Exercise and Relaxation Intervention for Young Adult Cancer Survivors

NCT ID: NCT00801008

Last Updated: 2012-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2013-12-31

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).

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Exercise and Relaxation Intervention

Participants in this arm will receive a 12 week exercise and relaxation intervention

Group Type: EXPERIMENTAL

Exercise and relaxation intervention

Intervention Type: BEHAVIORAL

Comparison of an exercise and relaxation intervention to a wait-list control condition

Wait List Control Condition

Participants in this arm will be offered the exercise and relaxation intervention after a 12 week delay.

Group Type: NO_INTERVENTION

Exercise and relaxation intervention

Intervention Type: BEHAVIORAL

Comparison of an exercise and relaxation intervention to a wait-list control condition

Interventions

Exercise and relaxation intervention

Comparison of an exercise and relaxation intervention to a wait-list control condition

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Women and Infants Hospital of Rhode Island

OTHER

Sponsor Role: collaborator

The Miriam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Carolyn Rabin

Assistant Professor (Research)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carolyn Rabin, PhD

Role: PRINCIPAL_INVESTIGATOR

The Miriam Hospital

Locations

Miriam Hospital

Providence, Rhode Island, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Carolyn Rabin, PhD

Role: CONTACT

CRabin@lifespan.org

(401)793-8234

Facility Contacts

Carolyn Rabin, PhD

Role: primary

CRabin@lifespan.org

401-793-8234

Other Identifiers

MRSG-09-091-01-CPPB

Identifier Type: -

Identifier Source: secondary_id

09-091-01-CPPB

Identifier Type: -

Identifier Source: org_study_id