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

Primary Purpose

Breast Cancer Survivor, Breast Cancer, Fitness Trackers

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Move Together app/Garmin Activity Tracker
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer Survivor focused on measuring Digital Health Intervention, Breast Cancer Survivor, Breast Cancer, Garmin Activity Tracker, Move Together App, Fitness trackers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dana Farber Cancer Institute
  • University of Massachusetts Boston
  • University of Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pilot Study

Arm Description

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

Outcomes

Primary Outcome Measures

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.)

Secondary Outcome Measures

Number of Participants Screened Per Month
the number of participants screened per month during recruitment period (not cumulative)
Number of Participants Enrolled Per Month
number of participants consented to the study each month during enrollment period
Completion Rate
number of participants who completed all aspects of the protocol
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)
Number of Participants Recruited
Number of initial respondents who consent and enroll.
Number of Participants Completed Study
Total number of participants who completed the study
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

Full Information

First Posted
August 13, 2021
Last Updated
April 14, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
University of Massachusetts, Boston, University of Rochester, National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05011279
Brief Title
Move Together Boston Feasibility Pilot (Sit Less, Move More App for Black Breast Cancer Survivors & At-Risk Relatives)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
January 21, 2022 (Actual)
Study Completion Date
January 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
University of Massachusetts, Boston, University of Rochester, National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Survivor, Breast Cancer, Fitness Trackers
Keywords
Digital Health Intervention, Breast Cancer Survivor, Breast Cancer, Garmin Activity Tracker, Move Together App, Fitness trackers

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pilot Study
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Move Together app/Garmin Activity Tracker
Intervention Description
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 Outcome Measure Information:
Title
System Usability Scale (SUS) Score
Description
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.)
Time Frame
Assessed at 4 Weeks
Secondary Outcome Measure Information:
Title
Number of Participants Screened Per Month
Description
the number of participants screened per month during recruitment period (not cumulative)
Time Frame
4 month recruitment period
Title
Number of Participants Enrolled Per Month
Description
number of participants consented to the study each month during enrollment period
Time Frame
4 month enrollment period
Title
Completion Rate
Description
number of participants who completed all aspects of the protocol
Time Frame
4 Weeks
Title
Number of Study Days
Description
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)
Time Frame
baseline to 4 weeks (28 days)
Title
Number of Participants Recruited
Description
Number of initial respondents who consent and enroll.
Time Frame
during 4 month recruitment period
Title
Number of Participants Completed Study
Description
Total number of participants who completed the study
Time Frame
4 weeks
Title
Number of Participants Retained at the End of 4 Weeks
Description
Retention will be the number who remain in the study at the end of 4 weeks
Time Frame
Baseline to 4 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Marinac, PhD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Massachusetts Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02125
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14627
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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