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Clinical Trials/NCT01883635
NCT01883635
Completed
Phase 1

Dyadic Exercise Intervention for Cancer Survivors and Caregivers

University of Rochester1 site in 1 country44 target enrollmentMay 2013
ConditionsCancer

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Cancer
Sponsor
University of Rochester
Enrollment
44
Locations
1
Primary Endpoint
Psychological Distress
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The purpose of the study is to see whether exercise can improve the health and well-being of cancer survivors. We also want to know about the health and well being of caregivers.

Detailed Description

This was a pilot feasibility study to refine our methodology before a larger Phase II trial.

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
August 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Charles Kamen

Assistant Research Professor

University of Rochester

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • have physical limitations (e.g. cardiorespiratory, orthopedic) contraindicating participation in a low to moderate intensity home based walking and progressive resistance program, as assessed by their medical oncologist, their primary care physician, and/or the study medical monitor.
  • For caregivers, be currently undergoing active treatment for cancer

Outcomes

Primary Outcomes

Psychological Distress

Time Frame: Baseline to post-intervention (6 weeks later)

Change in psychological distress in the cancer survivor from baseline to 6 weeks, as measured by the Profile of Moods States (POMS) total score. At each time point (baseline and 6 weeks), this questionnaire had a total score range of 0-200, with lower scores signifying less distress. We subtracted the baseline POMS score from the 6 week POMS score; the change score reported below thus has a range from -200 to 200, with lower scores signifying less distress.

Secondary Outcomes

  • Immune Biomarkers(Baseline to post-intervention (6 weeks later))

Study Sites (1)

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