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

• ClinicalTrials.gov Identifier: NCT05011279
• Recruitment Status: Completed
• First Posted: August 18, 2021
• Results First Posted: May 8, 2023
• Last Update Posted: November 15, 2023
• Sponsor: Dana-Farber Cancer Institute
• Collaborators: University of Massachusetts, Boston; University of Rochester; National Cancer Institute (NCI)
• Information provided by (Responsible Party): Catherine Marinac, PhD, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: August 13, 2021
• First Posted Date: August 18, 2021
• Results First Submitted Date: December 28, 2022
• Results First Posted Date: May 8, 2023
• Last Update Posted Date: November 15, 2023
• Actual Study Start Date: September 10, 2021
• Actual Primary Completion Date: January 21, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 14, 2023)

System Usability Scale (SUS) Score [ Time Frame: Assessed at 4 Weeks ]

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.)

Original Primary Outcome Measures (submitted: August 13, 2021)

System Usability Scale (SUS) score [ Time Frame: Baseline to 4 Weeks ]

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.)

Current Secondary Outcome Measures (submitted: April 14, 2023)

• Number of Participants Screened Per Month [ Time Frame: 4 month recruitment period ]
  the number of participants screened per month during recruitment period (not cumulative)
• Number of Participants Enrolled Per Month [ Time Frame: 4 month enrollment period ]
  number of participants consented to the study each month during enrollment period
• Completion Rate [ Time Frame: 4 Weeks ]
  number of participants who completed all aspects of the protocol
• Number of Study Days [ Time Frame: baseline to 4 weeks (28 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)
• Number of Participants Recruited [ Time Frame: during 4 month recruitment period ]
  Number of initial respondents who consent and enroll.
• Number of Participants Completed Study [ Time Frame: 4 weeks ]
  Total number of participants who completed the study
• Number of Participants Retained at the End of 4 Weeks [ Time Frame: Baseline to 4 Weeks ]
  Retention will be the number who remain in the study at the end of 4 weeks

Original Secondary Outcome Measures (submitted: August 13, 2021)

• Number of participants screened per month [ Time Frame: Baseline to 4 Weeks ]
  Measurement will be assessed by the completion rates at each time point divided by the number of participants enrolled at each time point
• Number of participants enrolled per month [ Time Frame: Baseline to 4 Weeks ]
  Measurement will be assessed by the completion rates at each time point divided by the number of participants enrolled at each time point
• Completion Rate [ Time Frame: Baseline to 4 Weeks ]
  rate of 70% of all participants completing each of these components per protocol
• Percentage of study days [ Time Frame: Baseline to 4 Weeks ]
  percentage of study days in which the participant uses the Move Together app and will describe engagement with the app. Achieving a minimum of using any app feature 4 out of 7 days will provide an indication of acceptability
• Percentage of participants recruited [ Time Frame: Baseline to 4 Weeks ]
  Percentage of initial respondents who consent and enroll. Achieving a minimum of enrolling 3 dyads per month as an indication of feasibility of recruitment.
• Percentage of participants completed study [ Time Frame: Baseline to 4 Weeks ]
  Achieving a minimum of 70% of those enrolled who complete all study data collection time-points will serve as an indication of the feasibility of the proposed study protocol
• Number of participants retained at the end of 4 weeks [ Time Frame: Baseline to 4 Weeks ]
  Retention will be the number who remain in the study at the end of 4 weeks

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

Detailed 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Breast Cancer Survivor
• Breast Cancer
• 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.

Study Arms

Experimental: Pilot Study

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

Intervention: Other: Move Together app/Garmin Activity Tracker

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 14, 2023): 10
• Original Estimated Enrollment (submitted: August 13, 2021): 58
• Actual Study Completion Date: January 21, 2022
• Actual Primary Completion Date: January 21, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05011279
• Other Study ID Numbers: 20-104; U54CA156732 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

• Current Responsible Party: Catherine Marinac, PhD, Dana-Farber Cancer Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Dana-Farber Cancer Institute
• Original Study Sponsor: Same as current

Collaborators

• University of Massachusetts, Boston
• University of Rochester
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Catherine Marinac, PhD; Dana-Farber Cancer Institute

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: November 2023