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Exercise and Relaxation Intervention for Young Adult Cancer Survivors

Cancer Clinical Trial

Clinical Trial Summary

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.

Clinical Trial Description

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). ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00801008
Study type Interventional
Source The Miriam Hospital
Contact Carolyn Rabin, PhD
Phone (401)793-8234
Email CRabin@lifespan.org
Status Recruiting
Phase N/A
Start date July 2009
Completion date December 2013
View Details
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