NCT00801008

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Jul 2009

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2008

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 20, 2012

Status Verified

April 1, 2012

Enrollment Period

4.4 years

First QC Date

December 2, 2008

Last Update Submit

April 19, 2012

Conditions

Keywords

young adultcancerexerciserelaxation

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

EXPERIMENTAL

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

Behavioral: Exercise and relaxation intervention

Wait List Control Condition

NO INTERVENTION

Participants in this arm will be offered the exercise and relaxation intervention after a 12 week delay.

Behavioral: Exercise and relaxation intervention

Interventions

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

Exercise and Relaxation InterventionWait List Control Condition

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Study Sites (1)

Miriam Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

NeoplasmsMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Carolyn Rabin, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolyn Rabin, PhD

CONTACT

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

Locations