Exercise and Relaxation Intervention for Young Adult Cancer Survivors

Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00801008
• Other study ID #: 09-091-01-CPPB
• Secondary ID: MRSG-09-091-01-C
• Status: Recruiting
• Phase: N/A
• First received: December 2, 2008
• Last updated: April 19, 2012
• Start date: July 2009
• Est. completion date: December 2013

Study information

• Verified date: April 2012
• Source: The Miriam Hospital
• Contact: Carolyn Rabin, PhD
• Phone: (401)793-8234
• Email: CRabin[@]lifespan.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 39 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Exercise and relaxation intervention
Comparison of an exercise and relaxation intervention to a wait-list control condition

Locations

Country	Name	City	State
United States	Miriam Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility measure: number of counseling sessions delivered		12 weeks	No
Primary	Acceptability measure: response to the item "In general how satisfied were you with the intervention?"		12 weeks	No
Secondary	Minutes of moderate-intensity activity on Seven Day PAR		12 weeks	No