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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborators:
University of Massachusetts, Boston
University of Rochester
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Catherine Marinac, PhD, Dana-Farber Cancer Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Survivor Breast Cancer Fitness Trackers Other: Move Together app/Garmin Activity Tracker Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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)
Actual Study Start Date : September 10, 2021
Actual Primary Completion Date : January 21, 2022
Actual Study Completion Date : January 21, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.)


Secondary Outcome Measures :
  1. Number of Participants Screened Per Month [ Time Frame: 4 month recruitment period ]
    the number of participants screened per month during recruitment period (not cumulative)

  2. Number of Participants Enrolled Per Month [ Time Frame: 4 month enrollment period ]
    number of participants consented to the study each month during enrollment period

  3. Completion Rate [ Time Frame: 4 Weeks ]
    number of participants who completed all aspects of the protocol

  4. 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)

  5. Number of Participants Recruited [ Time Frame: during 4 month recruitment period ]
    Number of initial respondents who consent and enroll.

  6. Number of Participants Completed Study [ Time Frame: 4 weeks ]
    Total number of participants who completed the study

  7. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05011279


Locations
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United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
University of Massachusetts Boston
Boston, Massachusetts, United States, 02125
United States, New York
University of Rochester
Rochester, New York, United States, 14627
Sponsors and Collaborators
Dana-Farber Cancer Institute
University of Massachusetts, Boston
University of Rochester
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Catherine Marinac, PhD Dana-Farber Cancer Institute
  Study Documents (Full-Text)

Documents provided by Catherine Marinac, PhD, Dana-Farber Cancer Institute:
Study Protocol and Statistical Analysis Plan  [PDF] June 29, 2021

More Information
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Responsible Party: Catherine Marinac, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT05011279    
Other Study ID Numbers: 20-104
U54CA156732 ( U.S. NIH Grant/Contract )
First Posted: August 18, 2021    Key Record Dates
Results First Posted: May 8, 2023
Last Update Posted: November 15, 2023
Last Verified: November 2023
Individual Participant Data (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
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Catherine Marinac, PhD, Dana-Farber Cancer Institute:
Digital Health Intervention
Breast Cancer Survivor
Breast Cancer
 Garmin Activity Tracker
Move Together App
Fitness trackers
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases