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Clinical Trials/NCT05011279
NCT05011279
Completed
N/A

"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)

Dana-Farber Cancer Institute3 sites in 1 country10 target enrollmentSeptember 10, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Breast Cancer Survivor
Sponsor
Dana-Farber Cancer Institute
Enrollment
10
Locations
3
Primary Endpoint
System Usability Scale (SUS) Score
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 10, 2021
End Date
January 21, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Catherine Marinac, PhD

Principal Investigator

Dana-Farber Cancer Institute

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)

Exclusion Criteria

  • (1a) Key informants (for interviews)
  • (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

Outcomes

Primary Outcomes

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

  • Number of Participants Screened Per Month(4 month recruitment period)
  • Number of Participants Enrolled Per Month(4 month enrollment period)
  • Number of Participants Completed Study(4 weeks)
  • Number of Participants Retained at the End of 4 Weeks(Baseline to 4 Weeks)
  • Completion Rate(4 Weeks)
  • Number of Study Days(baseline to 4 weeks (28 days))
  • Number of Participants Recruited(during 4 month recruitment period)

Study Sites (3)

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