Trial Outcomes & Findings for Shared Healthcare Actions and Reflections Electronic Systems in Survivorship (NCT NCT04337203)
NCT ID: NCT04337203
Last Updated: 2023-06-28
Results Overview
Using a 95% confidence interval (CI) to determine the range of estimates that are consistent with our data. Investigators will track the number of new patients seen in the Survivorship Clinic, and the percent who agree to be referred to SHARE-S.
COMPLETED
NA
40 participants
1 year, 8 months
2023-06-28
Participant Flow
Participant milestones
| Measure |
SHARE-S Intervention
SHARE-S Intervention
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
Baseline characteristics by cohort
| Measure |
Single Arm
n=40 Participants
Intervention
|
|---|---|
|
Age, Continuous
|
57.4 years
STANDARD_DEVIATION 15.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
BMI, Continuous
|
32.2 Kg/m^2
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Marital Status, Categorical
Currently Married
|
28 Participants
n=5 Participants
|
|
Marital Status, Categorical
Separated
|
1 Participants
n=5 Participants
|
|
Marital Status, Categorical
Divorced
|
3 Participants
n=5 Participants
|
|
Marital Status, Categorical
Widowed
|
2 Participants
n=5 Participants
|
|
Marital Status, Categorical
Single, never married
|
5 Participants
n=5 Participants
|
|
Marital Status, Categorical
Prefer not to answer
|
1 Participants
n=5 Participants
|
|
Highest Grade, Categorical
8th to 11th grade
|
1 Participants
n=5 Participants
|
|
Highest Grade, Categorical
High school or equivalent
|
5 Participants
n=5 Participants
|
|
Highest Grade, Categorical
Vocation/technical school post HS
|
1 Participants
n=5 Participants
|
|
Highest Grade, Categorical
Associate's degree/some college
|
8 Participants
n=5 Participants
|
|
Highest Grade, Categorical
Bachelor's degree
|
17 Participants
n=5 Participants
|
|
Highest Grade, Categorical
Graduate or professional school
|
8 Participants
n=5 Participants
|
|
Primary Tumor Site, Categorical
Breast
|
18 Participants
n=5 Participants
|
|
Primary Tumor Site, Categorical
Colorectal
|
1 Participants
n=5 Participants
|
|
Primary Tumor Site, Categorical
Endometrial
|
3 Participants
n=5 Participants
|
|
Primary Tumor Site, Categorical
Non-Hodgkin Lymphoma
|
1 Participants
n=5 Participants
|
|
Primary Tumor Site, Categorical
Prostate
|
10 Participants
n=5 Participants
|
|
Primary Tumor Site, Categorical
Other
|
7 Participants
n=5 Participants
|
|
History of Cancer-Related Surgical Procedure, Categorical
Yes
|
25 Participants
n=5 Participants
|
|
History of Cancer-Related Surgical Procedure, Categorical
No
|
15 Participants
n=5 Participants
|
|
History of Radiation Therapy, Categorical
Yes
|
28 Participants
n=5 Participants
|
|
History of Radiation Therapy, Categorical
No
|
12 Participants
n=5 Participants
|
|
History of Chemotherapy, Categorical
Yes
|
18 Participants
n=5 Participants
|
|
History of Chemotherapy, Categorical
No
|
22 Participants
n=5 Participants
|
|
Time since last treatment/surgery (months)
|
5 months
n=5 Participants
|
|
Difficult to pay monthly bills, Categorical
Very difficult
|
2 Participants
n=5 Participants
|
|
Difficult to pay monthly bills, Categorical
Somewhat difficult
|
8 Participants
n=5 Participants
|
|
Difficult to pay monthly bills, Categorical
Not very difficult
|
16 Participants
n=5 Participants
|
|
Difficult to pay monthly bills, Categorical
Not at all difficult
|
14 Participants
n=5 Participants
|
|
Travel to clinic bills (minutes)
|
31.5 minutes
STANDARD_DEVIATION 28.6 • n=5 Participants
|
|
Use internet or email at least occasionally, Categorical
Yes
|
38 Participants
n=5 Participants
|
|
Use internet or email at least occasionally, Categorical
No
|
2 Participants
n=5 Participants
|
|
Confident filling out medical forms, Categorical
Extremely
|
27 Participants
n=5 Participants
|
|
Confident filling out medical forms, Categorical
Quite a bit
|
11 Participants
n=5 Participants
|
|
Confident filling out medical forms, Categorical
Somewhat
|
2 Participants
n=5 Participants
|
|
Confident filling out medical forms, Categorical
A little bit
|
0 Participants
n=5 Participants
|
|
Confident filling out medical forms, Categorical
Not at all
|
0 Participants
n=5 Participants
|
|
Number of times received income assistance, Categorical
Never
|
30 Participants
n=5 Participants
|
|
Number of times received income assistance, Categorical
Once
|
4 Participants
n=5 Participants
|
|
Number of times received income assistance, Categorical
Twice
|
4 Participants
n=5 Participants
|
|
Number of times received income assistance, Categorical
Three times
|
1 Participants
n=5 Participants
|
|
Number of times received income assistance, Categorical
Four times
|
0 Participants
n=5 Participants
|
|
Number of times received income assistance, Categorical
More than four times
|
1 Participants
n=5 Participants
|
|
Rural residence, Categorical
Yes
|
5 Participants
n=5 Participants
|
|
Rural residence, Categorical
No
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year, 8 monthsPopulation: Total number reflects the total number of participants who were electronically referred in SHARE-S intervention.
Using a 95% confidence interval (CI) to determine the range of estimates that are consistent with our data. Investigators will track the number of new patients seen in the Survivorship Clinic, and the percent who agree to be referred to SHARE-S.
Outcome measures
| Measure |
SHARE-S Intervention
n=118 Participants
Enrolled in intervention
|
SHARE-S Intervention - Follow-Up
Same cohort with 5 lost to follow-up at time of subsequent survey administration
|
|---|---|---|
|
Number of Patients Enrolled Out of Those Electronically Referred
|
40 number of participants
Interval 29.0 to 50.0
|
—
|
SECONDARY outcome
Timeframe: 1 year, 8 monthsPopulation: Total number given a care plan
Using a 95% confidence interval to determine the range of estimates that are consistent with our data. Investigators will track the number of new patients seen in the Survivorship Clinic, and the percent who agree to enroll in SHARE-S
Outcome measures
| Measure |
SHARE-S Intervention
n=409 Participants
Enrolled in intervention
|
SHARE-S Intervention - Follow-Up
Same cohort with 5 lost to follow-up at time of subsequent survey administration
|
|---|---|---|
|
Adoption - Number of Electronically Referred Patients - Those Possible [Based on Chart Review]
|
118 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 30 days after the final intervention session.Population: Initial cohort less 6 lost to follow-up at time of subsequent survey administration
This measure will be used along with qualitative feedback among participants using a mixed-methods to assess acceptability of intervention with different cancer types. Acceptability ranges from 1-5 with higher scores indicating more acceptability.
Outcome measures
| Measure |
SHARE-S Intervention
n=34 Participants
Enrolled in intervention
|
SHARE-S Intervention - Follow-Up
Same cohort with 5 lost to follow-up at time of subsequent survey administration
|
|---|---|---|
|
Acceptability of Intervention Measure
|
4.4 score on a scale
Standard Deviation .6
|
—
|
SECONDARY outcome
Timeframe: Up to 30 days after the final intervention session.Population: Initial cohort less 6 lost to follow-up at time of subsequent survey administration
This measure will be used along with qualitative feedback among participants using a mixed-methods to assess appropriateness of intervention with different cancer types. Appropriateness ranges from 1-5 with higher scores meaning more appropriateness.
Outcome measures
| Measure |
SHARE-S Intervention
n=34 Participants
Enrolled in intervention
|
SHARE-S Intervention - Follow-Up
Same cohort with 5 lost to follow-up at time of subsequent survey administration
|
|---|---|---|
|
Appropriateness of Intervention Measure
|
4.3 score on a scale
Standard Deviation 0.6
|
—
|
SECONDARY outcome
Timeframe: 1 year, 8 monthsPopulation: Number enrolled per month.
This will be defined as the average number of participants that enroll per month that the study is open to enrollment.
Outcome measures
| Measure |
SHARE-S Intervention
n=40 Participants
Enrolled in intervention
|
SHARE-S Intervention - Follow-Up
Same cohort with 5 lost to follow-up at time of subsequent survey administration
|
|---|---|---|
|
Number of Participants Enrolled Per Month
|
2 participants/month
Interval 0.0 to 7.0
|
—
|
SECONDARY outcome
Timeframe: Up to 30 days after the final intervention session.Population: Initial cohort less 6 lost to follow-up at time of subsequent survey administration
This measure will be used along with qualitative feedback among participants using a mixed-methods to assess feasibility of intervention with different cancer types. Feasibility ranges from 1-5 with higher scores indicating more feasibility.
Outcome measures
| Measure |
SHARE-S Intervention
n=34 Participants
Enrolled in intervention
|
SHARE-S Intervention - Follow-Up
Same cohort with 5 lost to follow-up at time of subsequent survey administration
|
|---|---|---|
|
Feasibility of Intervention Measure
|
4.3 score on a scale
Standard Deviation .5
|
—
|
SECONDARY outcome
Timeframe: Up to 30 days after the final intervention session.Population: SHARE-S Intervention enrolled participants less 5 lost in follow-up.
Retention is defined as participants that complete the follow up assessment.
Outcome measures
| Measure |
SHARE-S Intervention
n=40 Participants
Enrolled in intervention
|
SHARE-S Intervention - Follow-Up
Same cohort with 5 lost to follow-up at time of subsequent survey administration
|
|---|---|---|
|
Retention Rates
|
35 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 year, 8 monthsPopulation: 40 enrolled
Defined as participants that adhere to responding to text messages received during intervention.
Outcome measures
| Measure |
SHARE-S Intervention
n=40 Participants
Enrolled in intervention
|
SHARE-S Intervention - Follow-Up
Same cohort with 5 lost to follow-up at time of subsequent survey administration
|
|---|---|---|
|
Number of Participants Adhering to Text Responses
|
27 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 year, 8 monthsPopulation: 40 enrolled
Defined as adherence to completing coaching sessions during the intervention.
Outcome measures
| Measure |
SHARE-S Intervention
n=40 Participants
Enrolled in intervention
|
SHARE-S Intervention - Follow-Up
Same cohort with 5 lost to follow-up at time of subsequent survey administration
|
|---|---|---|
|
Participant Adherence to Coaching Sessions
|
36 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 30 days after the final intervention session.Population: 40 enrolled (mean minutes over coach calls at 3 timepoints).
Defined as how long each completed coaching sessions lasted during the intervention.
Outcome measures
| Measure |
SHARE-S Intervention
n=40 Participants
Enrolled in intervention
|
SHARE-S Intervention - Follow-Up
Same cohort with 5 lost to follow-up at time of subsequent survey administration
|
|---|---|---|
|
Length of Coaching Sessions
|
39 minutes
Interval 7.0 to 69.0
|
—
|
SECONDARY outcome
Timeframe: 1 year, 8 monthsPopulation: 40 enrolled
Defined as an observational checklist completed for a subset of coaching sessions.
Outcome measures
| Measure |
SHARE-S Intervention
n=40 Participants
Enrolled in intervention
|
SHARE-S Intervention - Follow-Up
Same cohort with 5 lost to follow-up at time of subsequent survey administration
|
|---|---|---|
|
Number of Coaching Sessions Completed
|
111 sessions
|
—
|
SECONDARY outcome
Timeframe: 1 year, 8 monthsPopulation: 40 participants enrolled
Number of patients enrolled will be defined as overall participants for the entirety of the study.
Outcome measures
| Measure |
SHARE-S Intervention
n=40 Participants
Enrolled in intervention
|
SHARE-S Intervention - Follow-Up
Same cohort with 5 lost to follow-up at time of subsequent survey administration
|
|---|---|---|
|
Total Number of Patients Enrolled
|
40 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 30 days after the final intervention session.Population: 40 participants enrolled
Adverse events related to the intervention will be assessed in adverse event log.
Outcome measures
| Measure |
SHARE-S Intervention
n=40 Participants
Enrolled in intervention
|
SHARE-S Intervention - Follow-Up
Same cohort with 5 lost to follow-up at time of subsequent survey administration
|
|---|---|---|
|
Frequency of Adverse Events
|
0 events
|
—
|
SECONDARY outcome
Timeframe: Up to 30 days after the final intervention session.Population: Initial cohort with 6 lost to follow-up at time of subsequent survey administration
Patient reported measure of patient-centered communication/relatedness completed only at follow-up. Range 0-35 with higher scores indicating better communication.
Outcome measures
| Measure |
SHARE-S Intervention
n=34 Participants
Enrolled in intervention
|
SHARE-S Intervention - Follow-Up
Same cohort with 5 lost to follow-up at time of subsequent survey administration
|
|---|---|---|
|
HEAL Patient-Provider Connection
|
32.3 score on a scale
Standard Deviation 4.2
|
—
|
SECONDARY outcome
Timeframe: At baseline and up to 30 days after the final intervention session.Population: 40 enrolled at baseline; 35 available at follow-up
Questionnaire to assess the social role (0-100), physical functioning (0-100), anxiety (0-100), depression (0-100), fatigue (0-100), sleep disturbance (0-100), pain interference (0-100), pain intensity (0-10). Lower scores indicate less of construct.
Outcome measures
| Measure |
SHARE-S Intervention
n=40 Participants
Enrolled in intervention
|
SHARE-S Intervention - Follow-Up
n=35 Participants
Same cohort with 5 lost to follow-up at time of subsequent survey administration
|
|---|---|---|
|
Patient-Reported Health Outcomes PROMIS Profile 29
physical function (0-100)
|
48.4 score on a scale
Standard Deviation 8.2
|
49.2 score on a scale
Standard Deviation 8.5
|
|
Patient-Reported Health Outcomes PROMIS Profile 29
anxiety (0-100)
|
50.6 score on a scale
Standard Deviation 9.8
|
49.0 score on a scale
Standard Deviation 8.5
|
|
Patient-Reported Health Outcomes PROMIS Profile 29
depression (0-100)
|
48.1 score on a scale
Standard Deviation 9.3
|
45.9 score on a scale
Standard Deviation 7.7
|
|
Patient-Reported Health Outcomes PROMIS Profile 29
fatigue (0-100)
|
51.3 score on a scale
Standard Deviation 10.9
|
49.2 score on a scale
Standard Deviation 11.5
|
|
Patient-Reported Health Outcomes PROMIS Profile 29
sleep disturbance (0-100)
|
49.6 score on a scale
Standard Deviation 7.4
|
48.9 score on a scale
Standard Deviation 6.3
|
|
Patient-Reported Health Outcomes PROMIS Profile 29
social roles (0-100)
|
51.2 score on a scale
Standard Deviation 9.4
|
54.2 score on a scale
Standard Deviation 10.8
|
|
Patient-Reported Health Outcomes PROMIS Profile 29
pain interference (0-100)
|
51.5 score on a scale
Standard Deviation 10.2
|
50.3 score on a scale
Standard Deviation 9.3
|
|
Patient-Reported Health Outcomes PROMIS Profile 29
pain intensity (0-10)
|
2.7 score on a scale
Standard Deviation 2.4
|
2.5 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: At baseline and up to 30 days after the final intervention session.Population: 40 enrolled at baseline; 35 answered follow-up questionnaire
Participants will only answer the single item question that provides an indication of perceived change in health. Score range: 1 - excellent health, 2 - very good health, 3 - good health, 4 - fair health and 5 - poor health.
Outcome measures
| Measure |
SHARE-S Intervention
n=40 Participants
Enrolled in intervention
|
SHARE-S Intervention - Follow-Up
n=35 Participants
Same cohort with 5 lost to follow-up at time of subsequent survey administration
|
|---|---|---|
|
36-Item Short Form Survey (SF-36)
|
3.15 score on a scale
Standard Deviation 0.83
|
3.15 score on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: At baseline and up to 30 days after the final intervention session.Population: 40 participants at baseline; 35 participants answered follow-up questionnaire
Investigators will only assess the quality of life of adult cancer survivors measuring domains of cancer survivorship that are cancer-specific. Cancer-Specific Quality of Life (range 15-105) - higher score indicates more quality of life; Benefits of Having Cancer (range 4-28) - higher score indicates more benefits; Positive Feelings (range 4-28) - lower score indicates more positive feelings.
Outcome measures
| Measure |
SHARE-S Intervention
n=40 Participants
Enrolled in intervention
|
SHARE-S Intervention - Follow-Up
n=35 Participants
Same cohort with 5 lost to follow-up at time of subsequent survey administration
|
|---|---|---|
|
Cancer-specific Quality of Life in Adult Cancer Survivors (QLACS) Questionnaire
Cancer-Specific Quality of Life
|
47 score on a scale
Standard Deviation 20.5
|
40.9 score on a scale
Standard Deviation 19.1
|
|
Cancer-specific Quality of Life in Adult Cancer Survivors (QLACS) Questionnaire
Benefits of Having Cancer
|
13.9 score on a scale
Standard Deviation 5.8
|
12.2 score on a scale
Standard Deviation 5.7
|
|
Cancer-specific Quality of Life in Adult Cancer Survivors (QLACS) Questionnaire
Positive Feelings
|
10.6 score on a scale
Standard Deviation 5.4
|
9.5 score on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: At baseline and up to 30 days after the final intervention session.Population: 40 participants at baseline; 35 participants answered follow-up questionnaire
The Index of Autonomous Functioning - self congruence subscale only. 5 Items were paired with a Likert-type scale with 1 = "not at all true", 2 = "a bit true", 3 = "somewhat true", 4 = "mostly true", and 5 = "completely true." Mean score is average of 5 items. Higher mean score indicate a higher level of self congruence functioning.
Outcome measures
| Measure |
SHARE-S Intervention
n=40 Participants
Enrolled in intervention
|
SHARE-S Intervention - Follow-Up
n=35 Participants
Same cohort with 5 lost to follow-up at time of subsequent survey administration
|
|---|---|---|
|
Index of Autonomous Functioning - Self Congruence Subscale Only
|
4.3 score on a scale
Standard Deviation .5
|
4.3 score on a scale
Standard Deviation .6
|
SECONDARY outcome
Timeframe: At baseline and up to 30 days after the final intervention session.Population: 40 participants at baseline; 35 participants answered follow-up questionnaire
A questionnaire made up of 6-items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident). Higher the mean score indicates higher self-efficacy.
Outcome measures
| Measure |
SHARE-S Intervention
n=40 Participants
Enrolled in intervention
|
SHARE-S Intervention - Follow-Up
n=35 Participants
Same cohort with 5 lost to follow-up at time of subsequent survey administration
|
|---|---|---|
|
Self-Efficacy to Manage Chronic Disease Questionnaire
|
7.7 score on a scale
Standard Deviation 1.8
|
7.8 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 1 year, 8 monthsPopulation: 34 participants available at follow-up
Self-reported use of the care plan since enrolled on the study.
Outcome measures
| Measure |
SHARE-S Intervention
n=34 Participants
Enrolled in intervention
|
SHARE-S Intervention - Follow-Up
Same cohort with 5 lost to follow-up at time of subsequent survey administration
|
|---|---|---|
|
Engagement With the Survivorship Care Plan
|
34 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 30 days after the final intervention session.Population: Follow-up only
Participants will evaluate their overall satisfaction with their care after the study intervention. Mean of Likert scale. 1=very poor, 5=very good.
Outcome measures
| Measure |
SHARE-S Intervention
n=35 Participants
Enrolled in intervention
|
SHARE-S Intervention - Follow-Up
Same cohort with 5 lost to follow-up at time of subsequent survey administration
|
|---|---|---|
|
Satisfaction of Care
|
4.8 score on a scale
Standard Deviation .4
|
—
|
SECONDARY outcome
Timeframe: At baseline and up to 30 days after the final intervention session.Population: 40 participants at baseline; 34 participants answered follow-up questionnaire
Participants will be asked about their tobacco use within the last seven days. Tobacco use is scored 1=yes, 0=no. Higher values represent more participants were tobacco users.
Outcome measures
| Measure |
SHARE-S Intervention
n=40 Participants
Enrolled in intervention
|
SHARE-S Intervention - Follow-Up
n=34 Participants
Same cohort with 5 lost to follow-up at time of subsequent survey administration
|
|---|---|---|
|
Health Behaviors Questionnaire - Tobacco Use
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At baseline and up to 30 days after the final intervention session.Population: Entire cohort at baseline; 34 participants at follow-up.
Participants will be asked individual questions about their alcohol use. Alcohol use disorder is on a scale of 0-12 with higher scores indicating more hazardous; men ≥ 4, women ≥ 3 is considered hazardous.
Outcome measures
| Measure |
SHARE-S Intervention
n=40 Participants
Enrolled in intervention
|
SHARE-S Intervention - Follow-Up
n=34 Participants
Same cohort with 5 lost to follow-up at time of subsequent survey administration
|
|---|---|---|
|
Health Behaviors Questionnaire - Alcohol Use Disorder
|
1.4 score on a scale
Standard Deviation 1.9
|
1.2 score on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: At baseline and up to 30 days after the final intervention session.Population: Entire cohort at baseline; 34 participants at follow-up.
Participants will be asked individual questions about their physical activity. Physical activity is minutes/week with \<90 minutes considered insufficient.
Outcome measures
| Measure |
SHARE-S Intervention
n=40 Participants
Enrolled in intervention
|
SHARE-S Intervention - Follow-Up
n=34 Participants
Same cohort with 5 lost to follow-up at time of subsequent survey administration
|
|---|---|---|
|
Health Behaviors Questionnaire - Physical Activity
|
124.5 minutes/week
Standard Deviation 140
|
162.4 minutes/week
Standard Deviation 157.2
|
SECONDARY outcome
Timeframe: At baseline and up to 30 days after the final intervention session.Population: Entire cohort at baseline; 34 participants at follow-up.
Participants will be asked individual questions about their fruit and vegetable intake. Mean for the responses were calculated in cups so ½ to 1 cup = 0.75 cups, at least 2-3 cups for both considered sufficient.
Outcome measures
| Measure |
SHARE-S Intervention
n=40 Participants
Enrolled in intervention
|
SHARE-S Intervention - Follow-Up
n=34 Participants
Same cohort with 5 lost to follow-up at time of subsequent survey administration
|
|---|---|---|
|
Health Behaviors Questionnaire - Fruit and Vegetable Intake
|
2.7 cups/day
Standard Deviation 1.2
|
3.2 cups/day
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: At baseline and up to 30 days after the final intervention session.Population: Entire cohort at baseline; 34 participants at follow-up.
Participants will be asked individual questions how many days/week they practice mindfulness.
Outcome measures
| Measure |
SHARE-S Intervention
n=40 Participants
Enrolled in intervention
|
SHARE-S Intervention - Follow-Up
n=34 Participants
Same cohort with 5 lost to follow-up at time of subsequent survey administration
|
|---|---|---|
|
Health Behaviors Questionnaire - Mindfulness Practice
|
1.8 days/week
Standard Deviation 2.1
|
3.4 days/week
Standard Deviation 2.1
|
Adverse Events
Overall
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Carol Kittel
Wake Forest Baptist Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place