Exercise Intervention for Cancer Survivors and Caregivers

Phase 1

Completed

• Conditions: Cancer
• Interventions: Behavioral: Survivor-only progressive walking and resistance exercise; Behavioral: Dyadic progressive walking and resistance exercise

• Registration Number: NCT01883635
• Lead Sponsor: University of Rochester

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-06-05
• Study First Submitted QC: 2013-06-18
• Study First Posted: 2013-06-21
• Primary Completion: 2015-05
• Study Completion: 2015-08
• Results First Submitted: 2015-08-24
• Results First Submitted QC: 2015-10-23
• Results First Posted: 2015-11-30
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-08
• Last Update Posted: 2016-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individual Exercise Intervention	Survivor-only progressive walking and resistance exercise	Survivor-only progressive walking and resistance exercise
Dyadic Exercise Intervention	Dyadic progressive walking and resistance exercise	Dyadic progressive walking and resistance exercise

Primary Outcome Measures

Name	Time	Method
Psychological Distress	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 Outcome Measures

Name	Time	Method
Immune Biomarkers	Baseline to post-intervention (6 weeks later)	We measured improvement in immune biomarkers with IL-6, an inflammatory cytokine assessed in the serum of cancer survivors. Numbers presented below are change scores calculated by subtracting baseline IL-6 from post-intervention IL-6 (6 weeks later); lower numbers indicate less inflammation, hypothesized to be linked with better immune function.

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States