NCT05011279

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
23 days until next milestone

Study Start

First participant enrolled

September 10, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2022

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

May 8, 2023

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

4 months

First QC Date

August 13, 2021

Results QC Date

December 28, 2022

Last Update Submit

November 13, 2023

Conditions

Breast Cancer SurvivorBreast CancerFitness Trackers

Keywords

Digital Health InterventionBreast Cancer SurvivorBreast CancerGarmin Activity TrackerMove Together AppFitness trackers

Outcome Measures

Primary Outcomes (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.)

    Assessed at 4 Weeks

Secondary Outcomes (7)

  • Number of Participants Screened Per Month

    4 month recruitment period

  • Number of Participants Enrolled Per Month

    4 month enrollment period

  • Completion Rate

    4 Weeks

  • Number of Study Days

    baseline to 4 weeks (28 days)

  • Number of Participants Recruited

    during 4 month recruitment period

  • +2 more secondary outcomes

Study Arms (1)

Pilot Study

EXPERIMENTAL

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

Interventions

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.

Pilot Study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a) 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
  • +9 more criteria

You may not qualify if:

  • (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)
  • Participated in interviews or user testing in prior phases of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Massachusetts Boston

Boston, Massachusetts, 02125, United States

Location

University of Rochester

Rochester, New York, 14627, United States

Location

Related Publications (1)

  • 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.

    PMID: 37223968DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Catherine Marinac
Organization
Dana-Farber Cancer Institute
CatherineR_Marinac@dfci.harvard.edu
617-632-4703

Study Officials

  • Catherine Marinac, PhD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 13, 2021

First Posted

August 18, 2021

Study Start

September 10, 2021

Primary Completion

January 21, 2022

Study Completion

January 21, 2022

Last Updated

November 15, 2023

Results First Posted

May 8, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, 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

Locations

US(3)