Exercise and Relaxation Intervention for Young Adult Cancer Survivors
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cancer
Started Jul 2009
Longer than P75 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2008
CompletedFirst Posted
Study publicly available on registry
December 3, 2008
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedApril 20, 2012
April 1, 2012
4.4 years
December 2, 2008
April 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Minutes of moderate-intensity activity on Seven Day PAR
12 weeks
Study Arms (2)
Exercise and Relaxation Intervention
EXPERIMENTALParticipants in this arm will receive a 12 week exercise and relaxation intervention
Wait List Control Condition
NO INTERVENTIONParticipants in this arm will be offered the exercise and relaxation intervention after a 12 week delay.
Interventions
Comparison of an exercise and relaxation intervention to a wait-list control condition
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Miriam Hospitallead
- Women and Infants Hospital of Rhode Islandcollaborator
Study Sites (1)
Miriam Hospital
Providence, Rhode Island, 02903, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carolyn Rabin, PhD
The Miriam Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor (Research)
Study Record Dates
First Submitted
December 2, 2008
First Posted
December 3, 2008
Study Start
July 1, 2009
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
April 20, 2012
Record last verified: 2012-04