Trial Outcomes & Findings for Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS) (NCT NCT04492007)
NCT ID: NCT04492007
Last Updated: 2025-02-03
Results Overview
The enrollment rate is defined as the number of potentially eligible couples (dyads) who have consented to participate in the study. 1 Dyad = 1 participant + their caregiver. Potentially eligible dyads (subjects and their caregivers) were approached and informed about the study. then the number of dyads who consented and completed.
COMPLETED
NA
46 participants
Baseline
2025-02-03
Participant Flow
Participants were enrolled in the study between 11/02/2020 - 8/10/2021 at one cancer center in North Carolina.
In total 46 participants, 23 patients, and 23 patients' caregivers were started to the study. Patients and their caregivers were graded as dyed; 16 dyed in the PRISM arm and 7 dyed in the control arm were enrolled in the study.
Participant milestones
| Measure |
Usual Care
Participants assigned to this arm will receive the standard of care that is provided to all patients.
|
Caregiver-Usual Care
The primary caregiver of the participants assigned to this arm will receive the standard of care that is provided to all patients.
|
PRISMS
Participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s).
|
Caregiver-PRISMS
The primary caregiver of the participants assigned to receive eceive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
16
|
16
|
|
Overall Study
COMPLETED
|
5
|
5
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
4
|
4
|
Reasons for withdrawal
| Measure |
Usual Care
Participants assigned to this arm will receive the standard of care that is provided to all patients.
|
Caregiver-Usual Care
The primary caregiver of the participants assigned to this arm will receive the standard of care that is provided to all patients.
|
PRISMS
Participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s).
|
Caregiver-PRISMS
The primary caregiver of the participants assigned to receive eceive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s).
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
2
|
|
Overall Study
Protocol Violation
|
1
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS)
Baseline characteristics by cohort
| Measure |
Usual Care
n=7 Participants
Participants assigned to this arm will receive the standard of care that is provided to all patients.
|
Caregiver-Usual Care
n=7 Participants
The primary caregiver of the participants assigned to this arm will receive the standard of care that is provided to all patients.
|
PRISMS
n=16 Participants
Participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s).
|
Caregiver-PRISMS
n=16 Participants
The primary caregiver of the participants assigned to receive eceive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s).
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
57.71 years
STANDARD_DEVIATION 25.81 • n=5 Participants
|
38.00 years
STANDARD_DEVIATION 27.47 • n=7 Participants
|
56.81 years
STANDARD_DEVIATION 13.73 • n=5 Participants
|
48.06 years
STANDARD_DEVIATION 16.30 • n=4 Participants
|
51.04 years
STANDARD_DEVIATION 19.72 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
16 participants
n=5 Participants
|
16 participants
n=4 Participants
|
46 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Potentially eligible dyads (subjects and their caregivers) were approached and informed about the study. A total of 29 dyads were approached and were eligible and 25 dyads were consented.
The enrollment rate is defined as the number of potentially eligible couples (dyads) who have consented to participate in the study. 1 Dyad = 1 participant + their caregiver. Potentially eligible dyads (subjects and their caregivers) were approached and informed about the study. then the number of dyads who consented and completed.
Outcome measures
| Measure |
Potentially Eligible Dyads Recruited Into The Study
n=29 Participants
The number of Dyads successfully consented and completed the baseline survey among all people approached for the study.
|
Usual Care- Caregivers
Caregivers of patient participants assigned to this arm will receive the standard of care that is provided to all patients.
|
PRISMS Patients
Patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s).
|
PRISMS- Caregivers
Caregivers of patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and their healthcare providers at the hospital(s).
|
|---|---|---|---|---|
|
Enrollment Number
|
25 Number of dyad participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, after consentPopulation: 25 dyads were consented.
Potentially Eligible Dyads Participants Actually Enrolled in the Study will be evaluated by the number of dyads who successfully consented and completed the baseline survey among all people approached for the study. 1 Dyad = 1 participant + their caregiver.
Outcome measures
| Measure |
Potentially Eligible Dyads Recruited Into The Study
n=25 Participants
The number of Dyads successfully consented and completed the baseline survey among all people approached for the study.
|
Usual Care- Caregivers
Caregivers of patient participants assigned to this arm will receive the standard of care that is provided to all patients.
|
PRISMS Patients
Patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s).
|
PRISMS- Caregivers
Caregivers of patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and their healthcare providers at the hospital(s).
|
|---|---|---|---|---|
|
Number of Potentially Eligible Dyads Participants Actually Enrolled in the Study
|
23 Number of dyad participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 3 months (2-month follow up survey)Population: The number of dyads who started to study completed baseline and post-intervention survey. Twenty-five dyads consented, and 23 of them completed the baseline survey.
The number of dyad Participants Enrolled who Remained in the Study and Completed the Post-Intervention Follow-Up Survey was assessed by the number of enrolled dyad participants who completed the 2-month follow-up survey at the end of the study period.
Outcome measures
| Measure |
Potentially Eligible Dyads Recruited Into The Study
n=23 Participants
The number of Dyads successfully consented and completed the baseline survey among all people approached for the study.
|
Usual Care- Caregivers
Caregivers of patient participants assigned to this arm will receive the standard of care that is provided to all patients.
|
PRISMS Patients
Patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s).
|
PRISMS- Caregivers
Caregivers of patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and their healthcare providers at the hospital(s).
|
|---|---|---|---|---|
|
Number of Dyads Remained in the Study and Completed the Post-Intervention Follow-Up Survey.
|
17 Number of dyad participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 2 months (Follow up survey)Population: Thirty -four participants (17 patients and 17 caregivers) who completed the survey questionnaires were included.
Usability of Reported Outcomes - Patient Reported Outcomes - Informed Symptom Management System (PRISMS) evaluates three aspects: General, content, and navigation, contains 19 items on a 5-point Likert scale, where 1 is "strongly disagree" and 5 is "strongly agree". The score for each aspect was calculated as the sum of the scores from all items in this aspect. The scores ranged between 5 and 25 for General and Content, and the Navigation score ranged between 9 and 45. The higher score of the specific aspect that patients and their caregivers reported indicates the better usability of the aspect. This survey was offered separately at the follow-up visit to patients and their caregivers. Participants who completed at least 80.00% of the questions were included in the analysis. Usual Care and Informed Symptom Management System (PRISMS) group scores were compared.
Outcome measures
| Measure |
Potentially Eligible Dyads Recruited Into The Study
n=5 Participants
The number of Dyads successfully consented and completed the baseline survey among all people approached for the study.
|
Usual Care- Caregivers
n=5 Participants
Caregivers of patient participants assigned to this arm will receive the standard of care that is provided to all patients.
|
PRISMS Patients
n=12 Participants
Patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s).
|
PRISMS- Caregivers
n=12 Participants
Caregivers of patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and their healthcare providers at the hospital(s).
|
|---|---|---|---|---|
|
Usability of Reported Outcomes - Patient Reported Outcomes - Informed Symptom Management System (PRISMS)
general aspect
|
17.00 score on a scale
Standard Deviation 3.65
|
17.50 score on a scale
Standard Deviation 2.07
|
20 score on a scale
Standard Deviation 3.66
|
20.36 score on a scale
Standard Deviation 3.20
|
|
Usability of Reported Outcomes - Patient Reported Outcomes - Informed Symptom Management System (PRISMS)
content aspect
|
19.75 score on a scale
Standard Deviation 4.99
|
18.50 score on a scale
Standard Deviation 3.11
|
20.71 score on a scale
Standard Deviation 3.41
|
21.36 score on a scale
Standard Deviation 3.83
|
|
Usability of Reported Outcomes - Patient Reported Outcomes - Informed Symptom Management System (PRISMS)
navigation aspect
|
35.69 score on a scale
Standard Deviation 7.46
|
37.45 score on a scale
Standard Deviation 7.24
|
38.16 score on a scale
Standard Deviation 6.37
|
30.75 score on a scale
Standard Deviation 1.89
|
PRIMARY outcome
Timeframe: 2-month followup surveyPopulation: Thirty -four participants (17 patients and 17 caregivers) who completed the survey questionnaires were included.
The satisfaction survey evaluates satisfaction with various aspects, contains 9 items on a 5-point Likert scale of 1 to 5, and higher scores reflect better satisfaction. Questions: Q1. The amount of time to review the program every time. Q2. Ease of navigating. Q3. Information I received. Q4. Quality of the information I received. Q5. The program has increased my knowledge about managing my symptoms and complications. Q6. The program has improved how I manage my symptoms and complications. Q7. The program has improved how I communicate with my family about sensitive topics related to my cancer care. Q8. The time and effort took me to complete. Q9. My knowledge about how my cancer has affected my partner and our relationship was improved. This survey was offered at the follow-up visit to patients and their caregivers separately. More than 80.00% of the questions answered were included in the analysis. The mean score for each question for Usual Care and PRISMS were compared.
Outcome measures
| Measure |
Potentially Eligible Dyads Recruited Into The Study
n=5 Participants
The number of Dyads successfully consented and completed the baseline survey among all people approached for the study.
|
Usual Care- Caregivers
n=5 Participants
Caregivers of patient participants assigned to this arm will receive the standard of care that is provided to all patients.
|
PRISMS Patients
n=12 Participants
Patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s).
|
PRISMS- Caregivers
n=12 Participants
Caregivers of patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and their healthcare providers at the hospital(s).
|
|---|---|---|---|---|
|
Satisfaction With the PRISMS Program
Q1
|
3.20 score on a scale
Standard Deviation 1.10
|
3.20 score on a scale
Standard Deviation 1.48
|
4.08 score on a scale
Standard Deviation 0.79
|
3.83 score on a scale
Standard Deviation 0.72
|
|
Satisfaction With the PRISMS Program
Q2
|
3.60 score on a scale
Standard Deviation 1.34
|
4.20 score on a scale
Standard Deviation 0.84
|
4.08 score on a scale
Standard Deviation 1.00
|
4 score on a scale
Standard Deviation 0.95
|
|
Satisfaction With the PRISMS Program
Q3
|
3.40 score on a scale
Standard Deviation 1.14
|
4.00 score on a scale
Standard Deviation 1.00
|
4.00 score on a scale
Standard Deviation 0.95
|
3.92 score on a scale
Standard Deviation 0.90
|
|
Satisfaction With the PRISMS Program
Q4
|
3.60 score on a scale
Standard Deviation 0.89
|
4.20 score on a scale
Standard Deviation 1.1
|
4.08 score on a scale
Standard Deviation 1.00
|
4 score on a scale
Standard Deviation 0.85
|
|
Satisfaction With the PRISMS Program
Q5
|
3.80 score on a scale
Standard Deviation 1.10
|
3.60 score on a scale
Standard Deviation 1.14
|
4.08 score on a scale
Standard Deviation 1.00
|
4.17 score on a scale
Standard Deviation 0.72
|
|
Satisfaction With the PRISMS Program
Q6
|
3.60 score on a scale
Standard Deviation 0.89
|
3.40 score on a scale
Standard Deviation 1.52
|
3.75 score on a scale
Standard Deviation 1.22
|
4.17 score on a scale
Standard Deviation 0.72
|
|
Satisfaction With the PRISMS Program
Q7
|
3.40 score on a scale
Standard Deviation 0.89
|
3.60 score on a scale
Standard Deviation 1.14
|
3.17 score on a scale
Standard Deviation 1.40
|
4.00 score on a scale
Standard Deviation 0.95
|
|
Satisfaction With the PRISMS Program
Q8
|
3.20 score on a scale
Standard Deviation 1.48
|
2.40 score on a scale
Standard Deviation 1.14
|
3.83 score on a scale
Standard Deviation 1.19
|
3.64 score on a scale
Standard Deviation 1.12
|
|
Satisfaction With the PRISMS Program
Q9
|
3.80 score on a scale
Standard Deviation 0.84
|
3.60 score on a scale
Standard Deviation 1.67
|
3.64 score on a scale
Standard Deviation 1.29
|
3.92 score on a scale
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: baseline , 2 monthsPopulation: Thirty -four participants (17 patients and 17 caregivers) who completed the survey questionnaires were included.
Quality of Life Change Over Time as Assessed by The Functional Assessment of Cancer Therapy - General (FACT-G) at baseline and follow-up visit to patients and their caregivers separately. Change from baseline is the post-baseline value minus the Baseline value. FACT-G is a 27-item survey that assesses physical, social/family, emotional, and functional well-being on a 5-point Likert scale, with 0 indicating "not at all" and 4 indicating "very much" in response to item questions. The total FACT-G score is calculated as the sum of four sub-scores including physical, social/family, emotional, and functional well-being. Total scores range between 0-108. Higher scores indicated better well-being. It has also demonstrated sensitivity to change over time Mean FACT-G difference between baseline and 2 months were presented.
Outcome measures
| Measure |
Potentially Eligible Dyads Recruited Into The Study
n=5 Participants
The number of Dyads successfully consented and completed the baseline survey among all people approached for the study.
|
Usual Care- Caregivers
n=5 Participants
Caregivers of patient participants assigned to this arm will receive the standard of care that is provided to all patients.
|
PRISMS Patients
n=12 Participants
Patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s).
|
PRISMS- Caregivers
n=12 Participants
Caregivers of patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and their healthcare providers at the hospital(s).
|
|---|---|---|---|---|
|
Difference of Quality of Life Change Over Time as Assessed by The Functional Assessment of Cancer Therapy - General (FACT-G).
|
18.43 score on a scale
Standard Deviation 13.59
|
13.57 score on a scale
Standard Deviation 33.64
|
7.41 score on a scale
Standard Deviation 8.98
|
9.53 score on a scale
Standard Deviation 13.86
|
SECONDARY outcome
Timeframe: Baseline and 2 monthsPopulation: Thirty -four participants (17 patients and 17 caregivers) who completed the survey questionnaires were included.
Difference of Anxiety Change Over Time as Assessed by PROMIS-Emotional Distress-Anxiety Short Form 7a used to examine the change in anxiety among patients and their caregivers separately, from Baseline to follow up (2 months). For all PROMS measurements, total raw scores are translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. The anxiety sub-scale of the PROMIS item bank measures the extent to which participants experience anxiety symptoms over the past 7 days using a 5-point Likert scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with the total scores range from 36.3 to 82.7 with higher scores reflect higher anxiety.
Outcome measures
| Measure |
Potentially Eligible Dyads Recruited Into The Study
n=5 Participants
The number of Dyads successfully consented and completed the baseline survey among all people approached for the study.
|
Usual Care- Caregivers
n=5 Participants
Caregivers of patient participants assigned to this arm will receive the standard of care that is provided to all patients.
|
PRISMS Patients
n=12 Participants
Patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s).
|
PRISMS- Caregivers
n=12 Participants
Caregivers of patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and their healthcare providers at the hospital(s).
|
|---|---|---|---|---|
|
Difference of Anxiety Change Over Time as Assessed by PROMIS-Emotional Distress-Anxiety Short Form 7a
|
6.56 score on a scale
Standard Deviation 1.55
|
10.02 score on a scale
Standard Deviation 8.48
|
13.42 score on a scale
Standard Deviation 3.59
|
13.22 score on a scale
Standard Deviation 3.62
|
SECONDARY outcome
Timeframe: Baseline, 2 monthsPopulation: Participants who completed the survey
Change of Depression Change Over Time as Assessed by PROMIS-Emotional Distress-Depression Short From 8b will be assessed by PROMIS-Emotional Distress-Depression Short From 8b. It is used to measure the change in depression scores among patients and their partners from Baseline (T1) to T2 (2 months post-T1). Required by the PROMIS scoring instrument, for all PROMS measurements, total raw scores are translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. The depression sub-scale of the PROMIS item bank measures the extent to which participants experience depressive symptoms in the past 7 days using a 5-point Likert scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with the total scores range from 24.7 to 63.5 with higher scores indicate greater depressive symptoms.
Outcome measures
| Measure |
Potentially Eligible Dyads Recruited Into The Study
n=5 Participants
The number of Dyads successfully consented and completed the baseline survey among all people approached for the study.
|
Usual Care- Caregivers
n=12 Participants
Caregivers of patient participants assigned to this arm will receive the standard of care that is provided to all patients.
|
PRISMS Patients
Patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s).
|
PRISMS- Caregivers
Caregivers of patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and their healthcare providers at the hospital(s).
|
|---|---|---|---|---|
|
Difference of Depression Change Over Time as Assessed by PROMIS-Emotional Distress-Depression Short From 8b
Patients
|
14.77 score on a scale
Standard Deviation 8.83
|
8.55 score on a scale
Standard Deviation 4.76
|
—
|
—
|
|
Difference of Depression Change Over Time as Assessed by PROMIS-Emotional Distress-Depression Short From 8b
Patients' caregiver
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20.94 score on a scale
Standard Deviation 5.60
|
11.08 score on a scale
Standard Deviation 1.63
|
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SECONDARY outcome
Timeframe: Baseline, 2 monthsPopulation: Thirty -four participants (17 patients and 17 caregivers) who completed the survey questionnaires were included.
Change Pain Score Over Time as Assessed by PROMIS Pain Interference - Short Form 6b will be assessed by PROMIS Pain Interference - Short Form 6b. It is used to measure the change in Pain. It was offered to patients and their caregivers separately. Required by the PROMIS scoring instrument, for all PROMS measurements, total raw scores are translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. The pain measures the extent to which patients experience problems with pain over the past 7 days using a 5-point Likert scale. Higher scores reflect greater Pain Interference. The score value ranges between 41-78.3.
Outcome measures
| Measure |
Potentially Eligible Dyads Recruited Into The Study
n=5 Participants
The number of Dyads successfully consented and completed the baseline survey among all people approached for the study.
|
Usual Care- Caregivers
n=5 Participants
Caregivers of patient participants assigned to this arm will receive the standard of care that is provided to all patients.
|
PRISMS Patients
n=12 Participants
Patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s).
|
PRISMS- Caregivers
n=12 Participants
Caregivers of patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and their healthcare providers at the hospital(s).
|
|---|---|---|---|---|
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Difference Pain Score Over Time as Assessed by PROMIS Pain Interference - Short Form 6b
|
7.28 score on a scale
Standard Deviation 13.00
|
24.85 score on a scale
Standard Deviation 5.28
|
13.02 score on a scale
Standard Deviation 2.39
|
7.72 score on a scale
Standard Deviation 15.60
|
SECONDARY outcome
Timeframe: Baseline, 2 monthsPopulation: Thirty -four participants (17 patients and 17 caregivers) who completed the survey questionnaires were included.
PROMIS Fatigue -Short Form 7a is used to measure the change in Fatigue among patients and their caregivers separately, from Baseline (T1) to T2 (2 months post-T1). Required by the PROMIS scoring instrument, for all PROMS measurements, total raw scores are translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. The fatigue scale measures the extent to which patients and their partners experience problems with fatigue over the past 7 days using a 5-point Likert scale. Higher scores reflect greater fatigue. Score value ranges between 29.4 - 83.2.
Outcome measures
| Measure |
Potentially Eligible Dyads Recruited Into The Study
n=5 Participants
The number of Dyads successfully consented and completed the baseline survey among all people approached for the study.
|
Usual Care- Caregivers
n=5 Participants
Caregivers of patient participants assigned to this arm will receive the standard of care that is provided to all patients.
|
PRISMS Patients
n=12 Participants
Patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s).
|
PRISMS- Caregivers
n=12 Participants
Caregivers of patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and their healthcare providers at the hospital(s).
|
|---|---|---|---|---|
|
Difference of Fatigue Change Over Time as Assessed by PROMIS Fatigue -Short Form 7a
|
8.73 score on a scale
Standard Deviation 29.94
|
46.19 score on a scale
Standard Deviation 6.18
|
10.86 score on a scale
Standard Deviation 7.48
|
16.28 score on a scale
Standard Deviation 5.76
|
SECONDARY outcome
Timeframe: Baseline, 2 monthsPopulation: Patients' caregivers participants responded to the survey questionnaire.
Change in Sleep among caregivers. was assessed by the 22-item version of the Zarit Burden Interview is a caregiver self-reported instrument. It is used to assess caregiving burden change among caregivers from Baseline (T1) to T2 (2 months post-T1). Each item on the interview is a statement that the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Higher scores reflect more severe burden, 0-21: no to mild burden; 21-40: mild to moderate burden; 41-60: moderate to severe burden; ≥ 61: severe burden. The score value ranges between 0-88.
Outcome measures
| Measure |
Potentially Eligible Dyads Recruited Into The Study
n=5 Participants
The number of Dyads successfully consented and completed the baseline survey among all people approached for the study.
|
Usual Care- Caregivers
n=12 Participants
Caregivers of patient participants assigned to this arm will receive the standard of care that is provided to all patients.
|
PRISMS Patients
Patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s).
|
PRISMS- Caregivers
Caregivers of patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and their healthcare providers at the hospital(s).
|
|---|---|---|---|---|
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Change in Sleep Among Caregivers.
|
16.49 score on a scale
Standard Deviation 29.84
|
0.40 score on a scale
Standard Deviation 11.15
|
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Adverse Events
Usual Care
Caregiver-Usual Care
PRISMS
Caregiver-PRISMS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Xianming Tan PhD
University of North Carolina Lineberger Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators' joint publication is required.
- Publication restrictions are in place
Restriction type: OTHER