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

NCT ID: NCT05011279

Last Updated: 2023-11-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-10

Study Completion Date

2022-01-21

Brief Summary

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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

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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.

Conditions

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Breast Cancer Survivor Breast Cancer Fitness Trackers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Move Together app/Garmin Activity Tracker

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Massachusetts, Boston

OTHER

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Catherine Marinac, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Catherine Marinac, PhD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

University of Massachusetts Boston

Boston, Massachusetts, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37223968 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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U54CA156732

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-104

Identifier Type: -

Identifier Source: org_study_id

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