跳至主要内容
临床试验/NCT05011279
NCT05011279已完成不适用

"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 Institute6 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
6
主要终点
System Usability Scale (SUS) Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • (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

结局指标

主要结局

System Usability Scale (SUS) Score

时间窗: 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.)

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Catherine Marinac, PhD

Principal Investigator

Dana-Farber Cancer Institute

研究点 (6)

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