Exercise and Relaxation Intervention for Young Adult Cancer Survivors

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.

Study Overview

• Status: Unknown
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Exercise and relaxation intervention

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).

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Miriam Hospital
      • Contact: Carolyn Rabin, PhD; Phone Number: 401-793-8234; Email: CRabin@lifespan.org
      • Principal Investigator: Carolyn Rabin, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise and Relaxation Intervention; Participants in this arm will receive a 12 week exercise and relaxation intervention	Behavioral: Exercise and relaxation intervention; Comparison of an exercise and relaxation intervention to a wait-list control condition
No Intervention: Wait List Control Condition; Participants in this arm will be offered the exercise and relaxation intervention after a 12 week delay.	Behavioral: Exercise and relaxation intervention; Comparison of an exercise and relaxation intervention to a wait-list control condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Feasibility measure: number of counseling sessions delivered	12 weeks
Acceptability measure: response to the item "In general how satisfied were you with the intervention?"	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Minutes of moderate-intensity activity on Seven Day PAR	12 weeks

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Collaborators: Women and Infants Hospital of Rhode Island
• Investigators: Principal Investigator: Carolyn Rabin, PhD, The Miriam Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: December 2, 2008
• First Submitted That Met QC Criteria: December 2, 2008
• First Posted (Estimate): December 3, 2008

Study Record Updates

• Last Update Posted (Estimate): April 20, 2012
• Last Update Submitted That Met QC Criteria: April 19, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: exercise; cancer; young adult; relaxation
• Other Study ID Numbers: 09-091-01-CPPB; MRSG-09-091-01-CPPB