Exercise and Relaxation Intervention for Young Adult Cancer Survivors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by The Miriam Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Women and Infants Hospital of Rhode Island
Information provided by (Responsible Party):
Carolyn Rabin, The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT00801008
First received: December 2, 2008
Last updated: April 19, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Cancer
Behavioral: Exercise and relaxation intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Feasibility measure: number of counseling sessions delivered [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Acceptability measure: response to the item "In general how satisfied were you with the intervention?" [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Minutes of moderate-intensity activity on Seven Day PAR [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00801008

Contacts
Contact: Carolyn Rabin, PhD (401)793-8234 CRabin@lifespan.org

Locations
United States, Rhode Island
Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Carolyn Rabin, PhD    401-793-8234    CRabin@lifespan.org   
Principal Investigator: Carolyn Rabin, PhD         
Sponsors and Collaborators
The Miriam Hospital
Women and Infants Hospital of Rhode Island
Investigators
Principal Investigator: Carolyn Rabin, PhD The Miriam Hospital
  More Information

No publications provided

Responsible Party: Carolyn Rabin, Assistant Professor (Research), The Miriam Hospital
ClinicalTrials.gov Identifier: NCT00801008     History of Changes
Other Study ID Numbers: 09-091-01-CPPB, MRSG-09-091-01-CPPB
Study First Received: December 2, 2008
Last Updated: April 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Miriam Hospital:
young adult
cancer
exercise
relaxation

ClinicalTrials.gov processed this record on April 23, 2014