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Breast Cancer SurvivorNCT05011279

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

A study testing Move Together app/Garmin Activity Tracker in people with Breast Cancer Survivor and Breast Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Move Together app/Garmin Activity Tracker
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
3 sitesUnited States
Study dates
10 Sep 2021to 21 Jan 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • (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)
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  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • University of Massachusetts Boston

    Boston, Massachusetts, 02125

  • University of Rochester

    Rochester, New York, 14627

Other trials in United States

About this study

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)

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.

Read the 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.
Being tested
Move Together app/Garmin Activity Tracker
Keywords
Digital Health Intervention, Breast Cancer Survivor, Breast Cancer, Garmin Activity Tracker, Move Together App, Fitness trackers
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Move Together app/Garmin Activity TrackerOther

    • 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 groups in NCT05011279
Study groupRoleWhat they receive
Pilot StudyExperimentalParticipants 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
Receives: Other: Move Together app/Garmin Activity Tracker

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.)

    Measured: Assessed at 4 Weeks

Secondary outcomes (7)

  1. Number of Participants Screened Per Month

    the number of participants screened per month during recruitment period (not cumulative)

    Measured: 4 month recruitment period

  2. Number of Participants Enrolled Per Month

    number of participants consented to the study each month during enrollment period

    Measured: 4 month enrollment period

  3. Completion Rate

    number of participants who completed all aspects of the protocol

    Measured: 4 Weeks

  4. 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)

    Measured: baseline to 4 weeks (28 days)

  5. Number of Participants Recruited

    Number of initial respondents who consent and enroll.

    Measured: during 4 month recruitment period

  6. Number of Participants Completed Study

    Total number of participants who completed the study

    Measured: 4 weeks

  7. 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

    Measured: Baseline to 4 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2021
  2. Study start10 Sep 2021
  3. Primary completion21 Jan 2022
  4. Study completion21 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05011279
Sponsor's protocol ID
20-104
Other IDs
U54CA156732
Status last verified
Nov 2023
First submitted
13 Aug 2021
Last updated
15 Nov 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Blazey M, Marinac C, Whiteley J, Peterson S, Burns White K, Jacques C, Lam H, Halpenny B, Patel S, Lamothe R, Wright J. Designing a Dyad-Based Digital Health Intervention to Reduce Sedentary Time in Black Breast Cancer Survivors and Their First-degree Relatives: Human-Centered Design Study. JMIR Form Res. 2023 May 24;7:e43592. doi: 10.2196/43592.

    PubMed 37223968

Questions about this trial

What is this clinical trial studying?

A study testing Move Together app/Garmin Activity Tracker in people with Breast Cancer Survivor and Breast Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

System Usability Scale (SUS) Score (time frame: Assessed at 4 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05011279, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.

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