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临床试验/NCT03612596
NCT03612596已完成不适用

Narrative Visualization for Breast Cancer Survivors' Physical Activity

The University of Texas Medical Branch, Galveston2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年9月1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
40
试验地点
2
主要终点
Percentage of Daily Workbook Entries Completed

研究概览

简要总结

This study tests the feasibility and acceptability of a physical activity intervention that combines use of a wearable activity monitor with a scrapbook. Half of the participants will receive this enhanced intervention, while the other half will receive a wearable activity monitor with a standard step log.

详细描述

Women breast cancer survivors could benefit from increased physical activity but are in need of greater motivation to be active. Interventions that use wearable activity monitors and mobile apps have shown promise in the short-term, but use drops off over time. Reports have suggested that users find the step data provided to be unclear and not very personally meaningful. The ultimate purpose of this line of research is to test whether enhanced motivational feedback, using scrapbooks, can increase motivation for activity. The scrapbooks will target integrated regulation, which is a type of motivation related to personal identity and values. Participants who receive this intervention will draw their step graph, add photographs and stickers an explanations to the graph, and answer reflection questions daily. Before testing the effects of this intervention on physical activity, the investigators must first ensure that the materials and procedures are feasible and acceptable. This small pilot study will allow the research team to iteratively test scrapbook materials and improve upon them for use in future studies. The investigators will compare an intervention using the enhanced materials to an intervention using only the wearable device, app, and a standard step log without scrapbook or reflection components. In addition to the primary outcome of feasibility (use of the scrapbook), the investigators will also explore the effects of the intervention on steps, motivational and values-related outcomes, and various aspects of feasibility and acceptability.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
55 Years 至 79 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age between 55 and 79 years
  • Self-reported diagnosis of breast cancer
  • BMI between 18 and 40 kg/m2
  • Willingness to be randomized to any condition
  • Participant is able to walk for exercise
  • Able to read and understand English
  • Daily access to a smartphone or similar device compatible with Garmin app
  • PAR-Q+ indicates that physical activity would be safe (with note from physician required if any heart-related questions are endorsed)

排除标准

  • Participant is active (150 minutes or more activity per week)
  • Major health interventions (surgery, radiation, chemo) within the past 6 months
  • Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
  • History of orthopedic complications that would prevent optimal participation
  • No active recurrence of cancer
  • Self-reported smoker
  • Reports psychological issues that would interfere with study completion (dementia, schizophrenia)
  • Reports hospitalization within the past year due to psychiatric problem(s)
  • Plans to be out of town for more than 2 weeks at a time during study period
  • Clinical judgement concerning safety
  • Currently participating in an organized commercial or research exercise program
  • Another member of the household is a participant or staff member on this trial
  • Current use of a wearable activity monitor

结局指标

主要结局

Percentage of Daily Workbook Entries Completed

时间窗: 12 weeks

Percentage of daily workbook entries completed out of the total possible number, measured by photography of intervention materials at 12 week assessment and then assessment of each page.

次要结局

  • Physical Activity as Measured by Daily Steps During No-intervention Maintenance Period(Change from 12 to 24 weeks)
  • Physical Activity as Measured by Steps Per Day During Intervention Period(Change from 0 to 12 weeks)
  • Basic Psychological Needs: Competence(0 to 12 weeks)
  • Self-reflection(Change from 0 to 12 weeks)
  • Intrinsic Regulation(Change from 0 to 12 weeks)
  • Integrated Regulation(Change from 0 to 12 weeks)
  • Basic Psychological Needs: Autonomy(Change from 0 to 12 weeks)
  • Exercise Identity(Change from 0 to 12 weeks)
  • Basic Psychological Needs: Relatedness(0 to 12 weeks)
  • Quality of Life (Physical, Social, Emotional, Functional, and Breast Cancer-specific)(Change from 0 to 12 weeks)
  • Importance of Valued Domains(Change from 0 to 12 weeks)
  • Engaged Living(Change from 0 to 12 weeks)
  • Success in Living According to Valued Domains(Change from 0 to 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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