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临床试验/NCT03386383
NCT03386383已完成不适用

mHealth Physical Activity Intervention for Survivors of Adolescent and Young Adult Cancers

UNC Lineberger Comprehensive Cancer Center6 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2018年2月28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
64
试验地点
6
主要终点
Accrual rate

研究概览

简要总结

The purpose of this study is to examine the feasibility, acceptability, and gather preliminary data on outcomes of a 3-month mHealth intervention to promote physical activity among adolescent and young adult (AYA) cancer survivors compared to a delayed intervention control group.

详细描述

Adolescent and young adult (AYA) survivors are not meeting recommended physical activity guidelines for cancer survivors, and few interventions to date have focused specifically on promoting physical activity among AYAs or capitalized on new technologies to deliver them. This is a pilot randomized controlled trial (RCT) to examine the feasibility, acceptability, and gather preliminary data on outcomes of a 3-month mHealth intervention to promote PA among AYA survivors compared to a delayed intervention control group. This project will focus on how to best integrate self-monitoring with wearable trackers, increase self-efficacy, enhance autonomous motivation, and promote social support in a mobile health behavioral intervention that promotes moderate-to-vigorous intensity physical activity (MVPA) among AYA survivors. Participants will be AYA cancer survivors (N=60), diagnosed at age 15 or older and currently age 18-39. AYA cancer survivors will be recruited from the three comprehensive cancer centers in North Carolina to participate in this study. The behavioral intervention will consist of an activity tracker, Facebook group, weekly email lessons, and weekly tailored feedback emails. Assessments of objectively-measured physical activity and other outcomes will be completed at baseline, 3, and 6 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

盲法说明

4

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with cancer (excluding basal cell skin cancer) at age 15 or older
  • Currently age 18-39
  • Are 0 to 10 years post active cancer treatment (i.e., current hormonal treatments or maintenance therapies are permissible)
  • Able to speak, read and write English
  • Have access to the Internet and computer on at least a weekly basis
  • Possession and usage of an Internet e-mail address or willingness to sign up for a free email account
  • Have active Facebook account
  • Willing to be randomized to either arm

排除标准

  • History of heart attack or stroke within past 6 months
  • Untreated hypertension, hyperlipidemia, or diabetes, unless permission is provided by their health care provider
  • Have a pre-existing medical condition(s) or contraindications that preclude adherence to an unsupervised exercise program, including cardiovascular disease, heart failure, pulmonary conditions, renal disease, and severe orthopedic conditions
  • Are already adhering to the American Cancer Society's recommendation of ≥150 minutes of moderate-intensity exercise per week (<150 minutes/week)
  • Current participation in another physical activity or weight control program
  • Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months
  • Plans for major surgery (e.g., breast reconstruction) during the study time frame

结局指标

主要结局

Accrual rate

时间窗: Through completion of study enrollment, an average of 6 months.

Number of participants who agreed to participate divided by the number of months of recruitment.

Participation rate

时间窗: Through completion of study enrollment, an average of 6 months.

Percentage of eligible participants who agreed to participate.

Retention rate at 3 months

时间窗: 3 months

Number of intervention participants who completed 3-month measures divided by the number who consented to participate.

次要结局

  • Satisfaction with intervention(6 months)
  • Intrinsic motivation(Baseline, 3 months, 6 months)
  • Retention rate at 6 months(6 months)
  • Weight(Baseline, 3 months, 6 months)
  • Adherence to physical activity monitoring(Through study completion, 6 months)
  • Physical activity: objective(Baseline, 3 months, 6 months)
  • Physical activity: self-report(Baseline, 3 months, 6 months)
  • Sedentary behavior: self-report(Baseline, 3 months, 6 months)
  • Social support for exercise(Baseline, 3 months, 6 months)
  • Self-efficacy for exercise(Baseline, 3 months, 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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