Clinical trial NCT00801008: Exercise and Relaxation Intervention for Young Adult Cancer Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Keywords: young adult
cancer
exercise
relaxation
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: Women and Infants Hospital of Rhode Island
First posted: 2008-12-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility measure: number of counseling sessions delivered
timeFrame: 12 weeks
measure: Acceptability measure: response to the item "In general how satisfied were you with the intervention?"
timeFrame: 12 weeks
Secondary outcomes:
measure: Minutes of moderate-intensity activity on Seven Day PAR
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Carolyn Rabin, PhD
role: PRINCIPAL_INVESTIGATOR
References: