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

"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)

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Breast Cancer Survivor; Fitness Trackers
• Intervention / Treatment: Other: Move Together app/Garmin Activity Tracker

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
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana Farber Cancer Institute
    • Boston, Massachusetts, United States, 02125
      • University of Massachusetts Boston
  • New York
    • Rochester, New York, United States, 14627
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Cancer Institute (NCI); University of Rochester; University of Massachusetts, Boston
• Investigators: Principal Investigator: Catherine Marinac, PhD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2021
• Primary Completion (Actual): January 21, 2022
• Study Completion (Actual): January 21, 2022

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: August 13, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Breast Cancer; Digital Health Intervention; Breast Cancer Survivor; Garmin Activity Tracker; Move Together App; Fitness trackers
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 20-104; U54CA156732 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No