跳至主要内容
临床试验/NCT00801008
NCT00801008Unknown不适用

Exercise and Relaxation Intervention for Young Adult Cancer Survivors

The Miriam Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Feasibility measure: number of counseling sessions delivered

研究概览

简要总结

The purpose of this study is to develop an exercise and relaxation program for young adults (age 18 to 39) who have completed their treatment for cancer.

详细描述

There is evidence that cancer diagnosis and treatment during young adulthood puts survivors at risk for a number of medical and psychosocial difficulties including cardiovascular disease, second cancers and psychological distress. The proposed research is aimed at developing a physical activity and relaxation intervention for young adult cancer survivors in order to address some of their medical and psychosocial risks. The objective of the study is to pilot test a 12-week physical activity and relaxation intervention in this population. We hypothesize that the intervention will be feasible for and acceptable to young adult cancer survivors. We also hypothesize that the intervention group will demonstrate increased levels of physical activity, improved mood and reduced fatigue relative to the wait list control group at the 12-week and 24-week follow-up assessments; statistically significant differences may not be found due to the small sample size, however. In addition, we will conduct exploratory tests of intervention effects on fitness, flexibility, body mass, and waist circumference. Sixty participants will be recruited for the pilot study. Participants will be randomly assigned to receive a 12-week physical activity and relaxation intervention or to a wait list control group. Intervention group participants will receive 12 weeks of behavior change counseling, based on the Transtheoretical Model and Social Cognitive Theory, to help them adopt a program of brisk walking and learn mindfulness meditation. They will also be given access to an online discussion group. Participants in both arms of the study will be assessed at baseline, 12 weeks, and 24 weeks. Following the 24-week assessment, wait list control participants will offered the 12-week intervention and one additional assessment (i.e., at 36 weeks). Data will be collected on intervention feasibility (e.g., number of counseling sessions delivered) and acceptability (e.g., general satisfaction ratings). ANCOVAs will be used to conduct preliminary tests of intervention effects (e.g., on physical activity, mood, and fatigue).

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
None

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

  • age 18 to 39
  • diagnosed with any form of cancer (except non-melanoma skin cancer)
  • diagnosed between age 18 and 39 in the past 10 years
  • completed all surgery, chemotherapy and radiation therapy
  • currently in a cancer remission
  • able to speak and write English fluently
  • sedentary (i.e., not regularly physically active)
  • not currently engaging in a relaxation strategy
  • score above a cutoff on a fatigue screener

排除标准

  • the intention to get pregnant
  • the presence of a known medical condition or history of severe psychiatric illness that would make participation dangerous or very difficult

结局指标

主要结局

Feasibility measure: number of counseling sessions delivered

时间窗: 12 weeks

Acceptability measure: response to the item "In general how satisfied were you with the intervention?"

时间窗: 12 weeks

次要结局

  • Minutes of moderate-intensity activity on Seven Day PAR(12 weeks)

研究者

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

Carolyn Rabin

Assistant Professor (Research)

The Miriam Hospital

研究点 (2)

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