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Completed

NCT Number: NCT05011279

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Move Together app/Garmin Activity Tracker

Other
  • 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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

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

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 18, 2021
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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