CClinicalTrials.gg
Status unknownNCT00801008Updated Apr 20, 2012

Exercise and Relaxation Intervention for Young Adult Cancer Survivors

An interventional study of Exercise and relaxation intervention in Cancer, sponsored by The Miriam Hospital. Status unknown at 1 site in United States. Open to participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2012-04-20.

Sponsored by The Miriam Hospital · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Apr 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 39 Years
Sex
All
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Study 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.

Read the 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).

02

Conditions studied

  • Cancer

Keywords

  • young adult
  • cancer
  • exercise
  • relaxation
03

In context

Lead sponsor

The Miriam Hospital is the lead sponsor of 178 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Exercise and Relaxation Intervention

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

    Behavioral: Exercise and relaxation intervention

  • 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

Interventions

  • BehavioralExercise and relaxation intervention

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

06

What researchers measure

Primary outcomes

  1. Feasibility measure: number of counseling sessions delivered

    Time frame: 12 weeks

  2. Acceptability measure: response to the item "In general how satisfied were you with the intervention?"

    Time frame: 12 weeks

Secondary outcomes

  1. Minutes of moderate-intensity activity on Seven Day PAR

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
  • Miriam Hospital
    Providence, Rhode Island 02903, United States
    • Carolyn Rabin, PhD · Contact · CRabin@lifespan.org · 401-793-8234
    • Carolyn Rabin, PhD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00801008
Lead sponsor
The Miriam Hospital
Collaborators
Women and Infants Hospital of Rhode Island
Responsible party
Carolyn Rabin (Assistant Professor (Research), The Miriam Hospital) — Principal investigator
First posted
Dec 3, 2008
Start date
Jul 2009
Primary completion
Dec 2013 (estimated)
Completion
Dec 2013 (estimated)
Last update
Apr 20, 2012

Study contacts

Carolyn Rabin, PhD
Contact
CRabin@lifespan.org
(401)793-8234
Carolyn Rabin, PhD
principal investigator · The Miriam Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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