Move Together Boston Feasibility Pilot (Sit Less, Move More App for Black Breast Cancer Survivors & At-Risk Relatives)

Study Overview
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Brief Summary
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The purpose of this study is to develop and test a mobile app for Black/African American breast cancer survivors and their relatives, called Move Together, that promotes sitting less and moving more for better health.

Detailed Description
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The purpose of this study is to develop and test a mobile app for Black/African American breast cancer survivors and their relatives, called Move Together, that promotes sitting less and moving more for better health. This is a cross-sectional descriptive study using structured interviews and qualitative data analysis to develop an intervention, followed by a pilot test of the intervention with pre- /post- measures. In study phase 1,involved qualitative interviews with 5 community leader key informants, 9 breast cancer survivors and 6 first degree relatives of a survivor. This part of the research study is a Pilot Study, which means it is the first time that researchers are studying usability and acceptability of the Move Together app. Participants in the pilot study will participate as members of family-based dyads (n=10 dyads). One member of each dyad will be a breast cancer survivor and one will be a blood relative Study involves screening for eligibility, interviews, questionnaires, Use of Move Together app with Garmin activity tracker watch Participation on the trial will be for 5 weeks About 20 people (10 survivors with 10 relatives) will participate in this part of the study, and a total of 58 people in the whole study.

Official Title
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Sitting Less, Moving More: Designing a Digital Health Intervention for Black and African American Women Breast Cancer Survivors and Their At-risk Relatives (Phase II)

Conditions
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Breast Cancer Survivor, Breast Cancer, Fitness Trackers

Intervention / Treatment
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* Other: Move Together app/Garmin Activity Tracker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1a) Key informants (for interviews) Members of the community/advisory groups, community health centers, or faith-based network members (e.g., Pink and Black, Faces of Faith). English speaking adults. (1b) Breast cancer survivors and relatives (for interviews) Self-identify as Black or African American Age 18 and over English speaking Female breast cancer survivor status post curative antineoplastic treatment (except ongoing hormonal treatment) with no evidence of disease, OR a first degree blood relative (parent, child, or full sibling), of any gender, of a so defined breast cancer survivor Self-report ever using a smart phone (2) Breast cancer survivors and relatives (for user testing/interviews) Self-identify as Black or African American Age 18 and over English speaking Female breast cancer survivor status post curative antineoplastic treatment (except ongoing hormonal treatment) with no evidence of disease, OR a first degree blood relative (parent, child, or full sibling), of any gender, of a so defined breast cancer survivor Self-report willing/able to download the app for testing on a smart phone Self-report willing/able to meet via Zoom for interview (3) Breast cancer survivors and relatives/buddies (for pilot testing) Self-identify as Black or African American Age 18 and over English speaking Breast cancer survivor status post curative antineoplastic treatment (except ongoing hormonal treatment) with no evidence of disease, OR a blood relative, of any gender, of a so defined breast cancer survivor Self-report willing/able to participate with a blood relative in survivor relative dyad Self-report willing/able to download the app for use on a smart phone Self-report willing/able to meet via Zoom for instructions and interview Exclusion Criteria: (1a) Key informants (for interviews) --None (1b) Breast cancer survivors and relatives (for interviews) Requires medically supervised physical activity (Physical Activity Readiness Question for Everyone, PAR-Q+, Question 7) Pregnant women (2) Breast cancer survivors and relatives (for user testing/interviews) Requires medically supervised physical activity (Physical Activity Readiness Question for Everyone, PAR-Q+, Question 7) Pregnant women (3) Breast cancer survivors and relatives/buddies (for pilot testing) Meets exclusion criterion of the Modified Physical Activity Readiness Questionnaire (PAR-Q) (modified) Participated in interviews or user testing in prior phases of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilot Study<br>Participants in the pilot study will participate as members of family-based dyads (n=5 dyads). One member of each dyad will be a breast cancer survivor and one will be a blood relative. Study involves interviews, questionnaires, Use of Move Together app with Garmin activity tracker watch | Other: Move Together app/Garmin Activity Tracker<br>* The Move Together app allows users to set daily goals for increasing physical activity and decreasing sedentary time, track progress on goals, message their buddy, and access external educational infographics and other resource links. Garmin activity tracker in this study is for participants to track their steps and sedentary time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System Usability Scale (SUS) Score | The acceptability of the Move Together app will also be assessed with The System Usability Scale (SUS) score. The scale has 10 items. Scores range from 0-100; a SUS score above a 68 is considered above average (https://www.usability.gov/how-to-and-tools/methods/system-usability-scale.html.) | Assessed at 4 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Screened Per Month | the number of participants screened per month during recruitment period (not cumulative) | 4 month recruitment period | 
| Number of Participants Enrolled Per Month | number of participants consented to the study each month during enrollment period | 4 month enrollment period | 
| Completion Rate | number of participants who completed all aspects of the protocol | 4 Weeks | 
| Number of Study Days | number of study days in which the participants uses the Move Together app and will describe engagement with the app in a 28 day period (i.e., study days) | baseline to 4 weeks (28 days) | 
| Number of Participants Recruited | Number of initial respondents who consent and enroll. | during 4 month recruitment period | 
| Number of Participants Completed Study | Total number of participants who completed the study | 4 weeks | 
| Number of Participants Retained at the End of 4 Weeks | Retention will be the number who remain in the study at the end of 4 weeks | Baseline to 4 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital Health Intervention, Breast Cancer Survivor, Breast Cancer, Garmin Activity Tracker, Move Together App, Fitness trackers