Trial Outcomes & Findings for The HEART Study (Healthy Eating and Recovery Together) (NCT NCT04552587)
NCT ID: NCT04552587
Last Updated: 2023-01-20
Results Overview
Investigator developed questionnaire investigating acceptability of session intervention and care plan. Items were rated on a 6-point descriptive scale from strongly disagree to strongly agree. Participants that meet criteria are those that chose moderately or strongly agree. Items included: Session made me feel prepared, care plan information was helpful emotionally, care plan was helpful practically, amount of information in care plan provided was appropriate, timing of session of session was appropriate.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
6 week follow-up visit
Results posted on
2023-01-20
Participant Flow
Head and neck cancer patients and caregivers were recruited at the end of radiation therapy.
Participant milestones
| Measure |
HEART
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
Patients
|
23
|
|
Overall Study
Caregivers
|
23
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
HEART
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support.
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|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
Baseline Characteristics
5 individuals who enrolled did not complete the study.
Baseline characteristics by cohort
| Measure |
HEART
n=46 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support.
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|---|---|
|
Age, Continuous
Caregivers
|
59 years
n=23 Participants • 5 individuals who enrolled did not complete the study.
|
|
Age, Continuous
Patients
|
63 years
n=23 Participants • 5 individuals who enrolled did not complete the study.
|
|
Sex: Female, Male
Caregivers · Female
|
18 Participants
n=23 Participants • 5 individuals who enrolled did not complete the study
|
|
Sex: Female, Male
Caregivers · Male
|
5 Participants
n=23 Participants • 5 individuals who enrolled did not complete the study
|
|
Sex: Female, Male
Patients · Female
|
7 Participants
n=23 Participants • 5 individuals who enrolled did not complete the study
|
|
Sex: Female, Male
Patients · Male
|
16 Participants
n=23 Participants • 5 individuals who enrolled did not complete the study
|
|
Ethnicity (NIH/OMB)
Caregiver · Hispanic or Latino
|
0 Participants
n=23 Participants • 5 individuals who enrolled did not complete the study
|
|
Ethnicity (NIH/OMB)
Caregiver · Not Hispanic or Latino
|
23 Participants
n=23 Participants • 5 individuals who enrolled did not complete the study
|
|
Ethnicity (NIH/OMB)
Caregiver · Unknown or Not Reported
|
0 Participants
n=23 Participants • 5 individuals who enrolled did not complete the study
|
|
Ethnicity (NIH/OMB)
Patient · Hispanic or Latino
|
0 Participants
n=23 Participants • 5 individuals who enrolled did not complete the study
|
|
Ethnicity (NIH/OMB)
Patient · Not Hispanic or Latino
|
23 Participants
n=23 Participants • 5 individuals who enrolled did not complete the study
|
|
Ethnicity (NIH/OMB)
Patient · Unknown or Not Reported
|
0 Participants
n=23 Participants • 5 individuals who enrolled did not complete the study
|
|
Race (NIH/OMB)
Caregivers · American Indian or Alaska Native
|
0 Participants
n=23 Participants • 5 individuals who enrolled in the study did not complete the study.
|
|
Race (NIH/OMB)
Caregivers · Asian
|
0 Participants
n=23 Participants • 5 individuals who enrolled in the study did not complete the study.
|
|
Race (NIH/OMB)
Caregivers · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=23 Participants • 5 individuals who enrolled in the study did not complete the study.
|
|
Race (NIH/OMB)
Caregivers · Black or African American
|
3 Participants
n=23 Participants • 5 individuals who enrolled in the study did not complete the study.
|
|
Race (NIH/OMB)
Caregivers · White
|
20 Participants
n=23 Participants • 5 individuals who enrolled in the study did not complete the study.
|
|
Race (NIH/OMB)
Caregivers · More than one race
|
0 Participants
n=23 Participants • 5 individuals who enrolled in the study did not complete the study.
|
|
Race (NIH/OMB)
Caregivers · Unknown or Not Reported
|
0 Participants
n=23 Participants • 5 individuals who enrolled in the study did not complete the study.
|
|
Race (NIH/OMB)
Patients · American Indian or Alaska Native
|
0 Participants
n=23 Participants • 5 individuals who enrolled in the study did not complete the study.
|
|
Race (NIH/OMB)
Patients · Asian
|
0 Participants
n=23 Participants • 5 individuals who enrolled in the study did not complete the study.
|
|
Race (NIH/OMB)
Patients · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=23 Participants • 5 individuals who enrolled in the study did not complete the study.
|
|
Race (NIH/OMB)
Patients · Black or African American
|
4 Participants
n=23 Participants • 5 individuals who enrolled in the study did not complete the study.
|
|
Race (NIH/OMB)
Patients · White
|
19 Participants
n=23 Participants • 5 individuals who enrolled in the study did not complete the study.
|
|
Race (NIH/OMB)
Patients · More than one race
|
0 Participants
n=23 Participants • 5 individuals who enrolled in the study did not complete the study.
|
|
Race (NIH/OMB)
Patients · Unknown or Not Reported
|
0 Participants
n=23 Participants • 5 individuals who enrolled in the study did not complete the study.
|
|
Region of Enrollment
United States
|
46 participants
n=46 Participants
|
PRIMARY outcome
Timeframe: 6 week follow-up visitInvestigator developed questionnaire investigating acceptability of session intervention and care plan. Items were rated on a 6-point descriptive scale from strongly disagree to strongly agree. Participants that meet criteria are those that chose moderately or strongly agree. Items included: Session made me feel prepared, care plan information was helpful emotionally, care plan was helpful practically, amount of information in care plan provided was appropriate, timing of session of session was appropriate.
Outcome measures
| Measure |
HEART Patients
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
HEART Caregivers
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Patient HRQOL Physical Scores
Patient HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Caregiver HRQOL Physical Scores
Caregiver HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
|---|---|---|---|---|
|
Number of Participants Meeting Patient-Caregiver Session and Care Plan Acceptability Criteria
Session made me feel prepared
|
18 participants
|
18 participants
|
—
|
—
|
|
Number of Participants Meeting Patient-Caregiver Session and Care Plan Acceptability Criteria
Care plan information was helpful emotionally
|
17 participants
|
15 participants
|
—
|
—
|
|
Number of Participants Meeting Patient-Caregiver Session and Care Plan Acceptability Criteria
Care plan was helpful practically
|
18 participants
|
18 participants
|
—
|
—
|
|
Number of Participants Meeting Patient-Caregiver Session and Care Plan Acceptability Criteria
Amount of information in the care plan provided was appropriate
|
18 participants
|
20 participants
|
—
|
—
|
|
Number of Participants Meeting Patient-Caregiver Session and Care Plan Acceptability Criteria
Session timing was appropriate
|
13 participants
|
9 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 week follow up visitNumber of caregivers receiving all session content and delivery of the intervention as planned (intro to session, nurse care plan discussion, viewed nutritional support video, app training).
Outcome measures
| Measure |
HEART Patients
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
HEART Caregivers
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Patient HRQOL Physical Scores
Patient HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Caregiver HRQOL Physical Scores
Caregiver HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
|---|---|---|---|---|
|
Intervention Delivery/ Fidelity
|
19 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and 6 week follow up visitPopulation: 50 enrolled, 4 lost to follow up
Percentage of those recruited who completed baseline and 6 week follow up surveys and the intervention session.
Outcome measures
| Measure |
HEART Patients
n=50 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
HEART Caregivers
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Patient HRQOL Physical Scores
Patient HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Caregiver HRQOL Physical Scores
Caregiver HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
|---|---|---|---|---|
|
Intervention Reach
|
46 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 week follow up visit only (no baseline comparison)Population: System Usability Scale only measured in Caregivers.
System Usability Scale (SUS) - The SUS consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Scores range from 0-100, with higher scores indicating better usability.
Outcome measures
| Measure |
HEART Patients
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
HEART Caregivers
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Patient HRQOL Physical Scores
Patient HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Caregiver HRQOL Physical Scores
Caregiver HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
|---|---|---|---|---|
|
Ease of Use/System Usability
|
76 score on a scale
Interval 20.0 to 98.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 6 week follow up visit30-item Cancer Survivors/Partners Unmet Needs instruments (CaSUN/ CaSPUN). Needs were endorsed on a yes/no basis, with a range of 0-30 total endorsed needs. A higher score indicates more endorsed needs. Average number of needs is reported.
Outcome measures
| Measure |
HEART Patients
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
HEART Caregivers
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Patient HRQOL Physical Scores
Patient HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Caregiver HRQOL Physical Scores
Caregiver HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
|---|---|---|---|---|
|
Mean Score of Unmet Needs
Baseline endorsed needs
|
9.5 score on a scale
Interval 5.8 to 13.2
|
8.6 score on a scale
Interval 5.5 to 11.7
|
—
|
—
|
|
Mean Score of Unmet Needs
6 week follow up visit endorsed needs
|
8.9 score on a scale
Interval 5.4 to 12.5
|
7.5 score on a scale
Interval 4.1 to 10.9
|
—
|
—
|
|
Mean Score of Unmet Needs
Change from baseline to 6 week follow up visit
|
-0.6 score on a scale
Interval -2.7 to 1.6
|
-1.0 score on a scale
Interval -3.7 to 1.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 6 week follow-up visitPROMIS Depression- SF v1.0 form 8A is an 8-item Patient-Reported Outcomes Measure Information System (PROMIS) short-form instrument. Respondents are asked how often in the past 7 days they have experienced specific depression symptoms, using a 5-point ordinal rating scale of "Never," "Rarely," "Sometimes," "Often," and "Always" whereby a higher score indicates higher depression. Raw score totals are converted to an item response theory-based T-scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10 with a range of 38.2 to 81.3. Therefore, a person with a T-score of 40 is one SD below the mean. A decrease in change from baseline to 6 week followup indicates reduced depression.
Outcome measures
| Measure |
HEART Patients
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
HEART Caregivers
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Patient HRQOL Physical Scores
Patient HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Caregiver HRQOL Physical Scores
Caregiver HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
|---|---|---|---|---|
|
PROMIS Depression- Short Form (SF) v1.0 Form 8A
Baseline
|
51.2 T-Score
Interval 47.2 to 55.1
|
51.1 T-Score
Interval 47.3 to 54.9
|
—
|
—
|
|
PROMIS Depression- Short Form (SF) v1.0 Form 8A
6 week follow up visit
|
48.0 T-Score
Interval 44.0 to 52.0
|
49.6 T-Score
Interval 45.8 to 53.4
|
—
|
—
|
|
PROMIS Depression- Short Form (SF) v1.0 Form 8A
Change from baseline to 6 week follow up visit
|
-3.2 T-Score
Interval -6.0 to -0.3
|
-1.5 T-Score
Interval -4.7 to 1.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 6 week follow-up visitThe 11-item Preparing for Life As a New Survivor (PLANS) Knowledge Subscale, developed at the University of Michigan, is utilized to evaluate survivor and caregiver (1) knowledge of diagnosis, treatment and side effects, and (2) communication with the cancer team regarding diagnosis, treatment and side effects and 3) preparedness for what to expect over the next year. Items are rated on a 6-point scale where: strongly disagree=1, moderately disagree =2, slightly disagree=3, slightly agree= 4, moderately agree=5 and strongly agree=6. Items were averaged, with a range of 1-6 with higher scores indicating higher levels of agreement.
Outcome measures
| Measure |
HEART Patients
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
HEART Caregivers
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Patient HRQOL Physical Scores
Patient HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Caregiver HRQOL Physical Scores
Caregiver HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
|---|---|---|---|---|
|
Mean Score of Survivorship Readiness/Caregiver Preparedness
Baseline
|
4.5 score on a scale
Interval 4.2 to 4.9
|
4.6 score on a scale
Interval 4.1 to 5.0
|
—
|
—
|
|
Mean Score of Survivorship Readiness/Caregiver Preparedness
6 week follow up visit
|
4.6 score on a scale
Interval 4.2 to 5.1
|
4.5 score on a scale
Interval 4.0 to 5.0
|
—
|
—
|
|
Mean Score of Survivorship Readiness/Caregiver Preparedness
Change from baseline to 6 weeks follow up
|
0.1 score on a scale
Interval -0.3 to 0.4
|
-0.1 score on a scale
Interval -0.4 to 0.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 6 week follow-up visitBased on the National Cancer Institute Follow-up Care Use Among Survivors (FOCUS) survey, two questions were asked: "How confident are you that you can get advice or information related to your/your loved one's cancer if you needed at this time?" and "How confident are you that you can (assist your loved one to) keep to the follow-up care schedule recommended by your doctors?" Participants rated items on a 5-point Likert scale where 0="Not at all confident" to 4= "Completely confident." Scores were averaged for each question, whereby higher scores indicated higher level of confidence. Change from baseline to 6 week follow up is also reported. Negative change indicates decline in self-efficacy.
Outcome measures
| Measure |
HEART Patients
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
HEART Caregivers
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Patient HRQOL Physical Scores
Patient HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Caregiver HRQOL Physical Scores
Caregiver HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
|---|---|---|---|---|
|
Mean Score of Self-Efficacy
Baseline- Self Efficacy: confidence in obtaining cancer related advice
|
3.3 score on a scale
Interval 2.9 to 3.6
|
3.0 score on a scale
Interval 2.5 to 3.5
|
—
|
—
|
|
Mean Score of Self-Efficacy
6 week f/u Self Efficacy: confidence in obtaining cancer related advice/adhering to follow up care
|
3.2 score on a scale
Interval 2.8 to 3.6
|
2.8 score on a scale
Interval 2.3 to 3.3
|
—
|
—
|
|
Mean Score of Self-Efficacy
Change- Self Efficacy: confidence in obtaining cancer related advice/adhering to follow up care
|
-0.1 score on a scale
Interval -0.5 to 0.4
|
-0.2 score on a scale
Interval -0.8 to 0.4
|
—
|
—
|
|
Mean Score of Self-Efficacy
Baseline- Self Efficacy: adhering to recommended follow up care
|
3.6 score on a scale
Interval 3.4 to 3.6
|
3.3 score on a scale
Interval 3.0 to 3.7
|
—
|
—
|
|
Mean Score of Self-Efficacy
6 week f/u visit- Self Efficacy: adhering to recommended follow up care
|
3.6 score on a scale
Interval 3.3 to 3.8
|
3.4 score on a scale
Interval 3.1 to 3.7
|
—
|
—
|
|
Mean Score of Self-Efficacy
Change - Self Efficacy: adhering to recommended follow up care
|
0.0 score on a scale
Interval -0.2 to 0.2
|
0.1 score on a scale
Interval -0.4 to 0.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 6 week follow-up visitDyadic Coping was measured using a 5-item cancer-specific subscale version of the Dyadic Coping Inventory. Items are rated on a 5-point scale from 1 ("never") to 5 ("always"). Scores were averaged with a higher score indicating a better outcome. A decrease in change between baseline and 6 week followup visit indicates worsening outcome over time. Dyadic Efficacy is an investigator developed 1-item question "How confident are you that you and your loved one can work together as a team to manage the cancer-related problems that come up?" Item was answered on a scale of 0 ("not at all confident") to 10 ("extremely confident"), with average score reported. A decrease in change between baseline and 6 week followup visit indicates worsening, where as an increase in change indicates improvement.
Outcome measures
| Measure |
HEART Patients
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
HEART Caregivers
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Patient HRQOL Physical Scores
Patient HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Caregiver HRQOL Physical Scores
Caregiver HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
|---|---|---|---|---|
|
Mean Score of Dyadic Coping/ Dyadic Efficacy
Dyadic Coping: Baseline
|
4.3 score on a scale
Interval 4.0 to 4.7
|
4.1 score on a scale
Interval 3.6 to 4.5
|
—
|
—
|
|
Mean Score of Dyadic Coping/ Dyadic Efficacy
Dyadic Coping: 6 week follow up visit
|
4.2 score on a scale
Interval 3.8 to 4.6
|
4.1 score on a scale
Interval 3.6 to 4.5
|
—
|
—
|
|
Mean Score of Dyadic Coping/ Dyadic Efficacy
Dyadic Coping: Change from baseline to 6 week follow up
|
-0.2 score on a scale
Interval -0.4 to 0.1
|
0.0 score on a scale
Interval -0.4 to 0.4
|
—
|
—
|
|
Mean Score of Dyadic Coping/ Dyadic Efficacy
Dyadic Efficacy: Baseline
|
9.0 score on a scale
Interval 7.9 to 10.0
|
8.2 score on a scale
Interval 7.4 to 9.0
|
—
|
—
|
|
Mean Score of Dyadic Coping/ Dyadic Efficacy
Dyadic Efficacy: 6 week follow up visit
|
8.3 score on a scale
Interval 7.3 to 9.3
|
8.6 score on a scale
Interval 7.8 to 9.4
|
—
|
—
|
|
Mean Score of Dyadic Coping/ Dyadic Efficacy
Dyadic Efficacy: Change from baseline to 6 week follow up
|
-0.6 score on a scale
Interval -1.3 to 0.1
|
0.4 score on a scale
Interval -0.3 to 1.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 6 week follow-up visitPROMIS Scale v1.2 - Global Health short form consists of 10 items that assess overall perceived quality of life and five general domains of health and functioning including overall physical health, mental health, social health, pain, and fatigue. Scoring uses a 5-point Likert scale with the response scores reversed (5=None to 1=Very severe) so that higher scores for responses always indicate better health. Raw scores are summed and converted to a T-score (mean score of 50, SD ± 10), Therefore a person with a T-score of 40 is one SD below the mean. A decrease in the change from baseline to 6 week follow up indicates worsening quality of life, whereas an increase indicates improvement.
Outcome measures
| Measure |
HEART Patients
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
HEART Caregivers
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Patient HRQOL Physical Scores
n=23 Participants
Patient HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Caregiver HRQOL Physical Scores
n=23 Participants
Caregiver HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
|---|---|---|---|---|
|
Health-Related Quality-of-Life (PROMIS Scale v1.2 - Global Health)
Baseline
|
47.7 T-Score
Interval 43.5 to 51.8
|
49.0 T-Score
Interval 45.4 to 52.6
|
42.4 T-Score
Interval 39.5 to 45.2
|
50.4 T-Score
Interval 47.8 to 53.1
|
|
Health-Related Quality-of-Life (PROMIS Scale v1.2 - Global Health)
6 week follow up visit
|
46.6 T-Score
Interval 43.8 to 49.5
|
48.5 T-Score
Interval 44.2 to 52.7
|
44.6 T-Score
Interval 41.4 to 47.7
|
50.4 T-Score
Interval 47.5 to 53.3
|
|
Health-Related Quality-of-Life (PROMIS Scale v1.2 - Global Health)
Change from baseline to 6 week follow up visit
|
-1.0 T-Score
Interval -4.0 to 1.9
|
-0.5 T-Score
Interval -3.5 to 2.5
|
2.2 T-Score
Interval 0.04 to 4.4
|
-0.05 T-Score
Interval -1.8 to 1.7
|
SECONDARY outcome
Timeframe: Baseline and 6 week follow up visitPopulation: Change in mean score from baseline to six weeks measured in caregivers only
4-item screening version of the Zarit Burden Interview is a self-report measure of caregiver burden. Caregivers rate each item on a 5-point Likert scale (0=never, 4= nearly always). Higher scores indicate greater caregiver distress. Total score range: 0 to 16, ≥ 8: high burden. An increase in change from baseline to 6 week follow up visit indicates increased caregiver distress.
Outcome measures
| Measure |
HEART Patients
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
HEART Caregivers
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Patient HRQOL Physical Scores
Patient HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Caregiver HRQOL Physical Scores
Caregiver HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
|---|---|---|---|---|
|
Caregiver Burden
6 Week follow up visit
|
1.9 units on a scale
Interval 1.6 to 2.3
|
—
|
—
|
—
|
|
Caregiver Burden
Baseline
|
1.8 units on a scale
Interval 1.5 to 2.1
|
—
|
—
|
—
|
|
Caregiver Burden
Change from baseline to 6 week follow up visit
|
0.1 units on a scale
Interval -0.1 to 0.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks during app usePopulation: Measured in Caregivers only. (23 caregivers given 2 prompts per week for 4 weeks= 184 prompts).
Number of weekly prompt responses missed out of 184 total expected (23 caregivers given 2 prompts per week for 4 weeks).
Outcome measures
| Measure |
HEART Patients
n=184 prompts
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
HEART Caregivers
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Patient HRQOL Physical Scores
Patient HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Caregiver HRQOL Physical Scores
Caregiver HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
|---|---|---|---|---|
|
Ease of Mobile App Use/User Engagement
|
70 number of missed prompts
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 week follow up visitNumber of participants of use of care plan after session, including patient and caregiver report of "Referred to Care Plan again," "Used Care Plan," "Used educational materials," and "Shared Care Plan with others."
Outcome measures
| Measure |
HEART Patients
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
HEART Caregivers
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Patient HRQOL Physical Scores
Patient HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Caregiver HRQOL Physical Scores
Caregiver HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
|---|---|---|---|---|
|
Number of Participants With Care Plan Use Endpoints
Referred to Care plan again
|
17 Participants
|
20 Participants
|
—
|
—
|
|
Number of Participants With Care Plan Use Endpoints
Used Care Plan
|
10 Participants
|
8 Participants
|
—
|
—
|
|
Number of Participants With Care Plan Use Endpoints
Used educational materials
|
10 Participants
|
16 Participants
|
—
|
—
|
|
Number of Participants With Care Plan Use Endpoints
Shared Care Plan with others
|
7 Participants
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 week follow up visitRatings of satisfaction with app and prompts on a 6 point descriptive rating scale ranging from strongly agree to strongly disagree. Measurements reported below are count of participants who moderately or strongly agreed with individual prompts.
Outcome measures
| Measure |
HEART Patients
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
HEART Caregivers
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Patient HRQOL Physical Scores
Patient HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Caregiver HRQOL Physical Scores
Caregiver HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
|---|---|---|---|---|
|
Percentage of Participants Rating App Satisfaction/ Perceived Importance
App support received helped you provide care for your loved one
|
17 Participants
|
13 Participants
|
—
|
—
|
|
Percentage of Participants Rating App Satisfaction/ Perceived Importance
App support was helpful emotionally
|
15 Participants
|
11 Participants
|
—
|
—
|
|
Percentage of Participants Rating App Satisfaction/ Perceived Importance
App provided practical tips
|
10 Participants
|
12 Participants
|
—
|
—
|
|
Percentage of Participants Rating App Satisfaction/ Perceived Importance
Amount of app information was appropriate
|
15 Participants
|
16 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: After session completionResources needed: Session length overall, length of nursing portion of session, length of app training- number of minutes
Outcome measures
| Measure |
HEART Patients
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
HEART Caregivers
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Patient HRQOL Physical Scores
Patient HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Caregiver HRQOL Physical Scores
Caregiver HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
|---|---|---|---|---|
|
Process Monitoring Data
Length of full session
|
51 minutes
Interval 31.0 to 80.0
|
—
|
—
|
—
|
|
Process Monitoring Data
Length of nursing visit (within full session)
|
13 minutes
Interval 3.0 to 30.0
|
—
|
—
|
—
|
|
Process Monitoring Data
Length of App Training
|
12 minutes
Interval 7.0 to 35.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 6 week follow up visitInvestigator-developed 1 item: "During the past two weeks, how satisfied have you been with your nutritional status (from Extremely satisfied (1) to Not at all satisfied (5))?"
Outcome measures
| Measure |
HEART Patients
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
HEART Caregivers
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Patient HRQOL Physical Scores
Patient HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Caregiver HRQOL Physical Scores
Caregiver HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
|---|---|---|---|---|
|
Change From Baseline in Nutritional Status Scale
Baseline
|
3.5 score on a scale
Interval 3.0 to 4.0
|
3.3 score on a scale
Interval 2.7 to 3.9
|
—
|
—
|
|
Change From Baseline in Nutritional Status Scale
6 week follow up visit
|
3.0 score on a scale
Interval 2.6 to 3.5
|
2.5 score on a scale
Interval 2.1 to 3.0
|
—
|
—
|
|
Change From Baseline in Nutritional Status Scale
Change from baseline to 6 week follow up visit
|
-0.5 score on a scale
Interval -1.0 to 0.0
|
-0.8 score on a scale
Interval -1.4 to -0.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 6 week follow up visitAdapted Symptom Distress Scale 1 item scaled to assess how distressing symptoms are to participant. 0= not at all distressing, 10= extremely distressing 1 item to assess patient and caregiver perceptions concerning patient ability to manage symptoms. 0= can manage extremely well, 10= cannot manage at all
Outcome measures
| Measure |
HEART Patients
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
HEART Caregivers
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Patient HRQOL Physical Scores
Patient HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Caregiver HRQOL Physical Scores
Caregiver HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
|---|---|---|---|---|
|
Change From Baseline in Symptom Distress/Symptom Management
Symptom Distress: Baseline
|
4.6 score on a scale
Interval 3.4 to 5.8
|
5.6 score on a scale
Interval 4.2 to 6.9
|
—
|
—
|
|
Change From Baseline in Symptom Distress/Symptom Management
Symptom Distress: 6 week follow up
|
4.2 score on a scale
Interval 2.8 to 5.6
|
4.3 score on a scale
Interval 3.0 to 5.6
|
—
|
—
|
|
Change From Baseline in Symptom Distress/Symptom Management
Symptom Distress: Baseline to 6 week follow up visit
|
-0.4 score on a scale
Interval -1.8 to 1.0
|
-1.3 score on a scale
Interval -2.7 to 0.2
|
—
|
—
|
|
Change From Baseline in Symptom Distress/Symptom Management
Symptom Management: Baseline
|
2.5 score on a scale
Interval 1.3 to 3.6
|
3.7 score on a scale
Interval 2.6 to 4.9
|
—
|
—
|
|
Change From Baseline in Symptom Distress/Symptom Management
Symptom Management: 6 week follow up
|
2.7 score on a scale
Interval 1.7 to 4.0
|
2.6 score on a scale
Interval 1.5 to 3.7
|
—
|
—
|
|
Change From Baseline in Symptom Distress/Symptom Management
Symptom Management: Baseline to 6 week follow up visit
|
0.2 score on a scale
Interval -1.1 to 1.6
|
-1.2 score on a scale
Interval -2.3 to 0.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 6 week follow up visitPROMIS Short Form v2.0 - Emotional Support - 4a is a 4-item questionnaire. Item banks (currently adults only) assess perceived feelings of being cared for and valued as a person; having confidant relationships. PROMIS instruments are scored using item-level calibrations. Each question usually has five response options ranging in value from one to five. Raw scores are the sum of values of the response to each question then rescaled to to a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean.
Outcome measures
| Measure |
HEART Patients
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
HEART Caregivers
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Patient HRQOL Physical Scores
Patient HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Caregiver HRQOL Physical Scores
Caregiver HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
|---|---|---|---|---|
|
Change From Baseline in Emotional Support
Baseline
|
56.0 T-Score
Interval 52.2 to 59.8
|
52.0 T-Score
Interval 48.1 to 55.8
|
—
|
—
|
|
Change From Baseline in Emotional Support
6 week follow up visit
|
55.7 T-Score
Interval 52.5 to 58.9
|
52.8 T-Score
Interval 49.5 to 56.0
|
—
|
—
|
|
Change From Baseline in Emotional Support
Change from baseline to 6 week follow up visit
|
-0.3 T-Score
Interval -2.6 to 1.9
|
0.8 T-Score
Interval -2.7 to 4.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 6 week follow up visitMD Anderson Symptom Inventory (MDASI) Head and Neck Module- Includes 13 core items and an additional 9 head and neck cancer module items which calculates a total score of symptom severity. The MDASI assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 Numeric Rating Scale, with 0 being "not present" and 10 being "as bad as you can imagine." Core items and module symptom items are averaged into a mean module severity. A higher score always indicates an increase in severity. A decrease in change from baseline to 6 week follow up indicates improvement of symptoms.
Outcome measures
| Measure |
HEART Patients
n=23 Participants
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
HEART Caregivers
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Patient HRQOL Physical Scores
Patient HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
Caregiver HRQOL Physical Scores
Caregiver HRQOL Physical scores
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Heart APP: The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support
|
|---|---|---|---|---|
|
Change From Baseline in Symptom Severity
Baseline
|
3.0 score on a scale
Interval 2.4 to 3.7
|
—
|
—
|
—
|
|
Change From Baseline in Symptom Severity
6 week follow up visit
|
2.0 score on a scale
Interval 1.3 to 2.8
|
—
|
—
|
—
|
|
Change From Baseline in Symptom Severity
Change from baseline to 6 week follow up visit
|
-1.0 score on a scale
Interval -1.6 to -0.4
|
—
|
—
|
—
|
Adverse Events
HEART Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HEART Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Katherine R. Sterba, PhD, MPH
Medical University of South Carolina
Phone: 843- 876-2419
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place