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18 Years
39 Years
Open (Enrolling)

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Trial Information

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).

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

Type of Study:


Study Design:

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

Outcome Measure:

Feasibility measure: number of counseling sessions delivered

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Carolyn Rabin, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Miriam Hospital


United States: Institutional Review Board

Study ID:




Start Date:

July 2009

Completion Date:

December 2013

Related Keywords:

  • Cancer
  • young adult
  • cancer
  • exercise
  • relaxation



Miriam Hospital Providence, Rhode Island  02906