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

Breast Cancer Clinical Trial

Official title:

"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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05011279
• Other study ID #: 20-104
• Secondary ID: U54CA156732
• Status: Completed
• Phase: N/A
• Start date: September 10, 2021
• Est. completion date: January 21, 2022

Study information

• Verified date: November 2023
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 21, 2022
• Est. primary completion date: January 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Survivor
• Breast Neoplasms
• Fitness Trackers

Intervention

Other:
• Move Together app/Garmin Activity Tracker
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.

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	University of Massachusetts Boston	Boston	Massachusetts
United States	University of Rochester	Rochester	New York

Sponsors (4)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Cancer Institute (NCI), University of Massachusetts, Boston, University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants Screened Per Month	the number of participants screened per month during recruitment period (not cumulative)	4 month recruitment period
Secondary	Number of Participants Enrolled Per Month	number of participants consented to the study each month during enrollment period	4 month enrollment period
Secondary	Completion Rate	number of participants who completed all aspects of the protocol	4 Weeks
Secondary	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)
Secondary	Number of Participants Recruited	Number of initial respondents who consent and enroll.	during 4 month recruitment period
Secondary	Number of Participants Completed Study	Total number of participants who completed the study	4 weeks
Secondary	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