Exercise Intervention for Cancer Survivors and Caregivers

Dyadic Exercise Intervention for Cancer Survivors and Caregivers

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Survivor-only progressive walking and resistance exercise; Behavioral: Dyadic progressive walking and resistance exercise

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria for Cancer Survivors:

• Have a diagnosis of cancer (any cancer type excluding squamous and basal cell skin cancers) and have received surgery, chemotherapy, and/or radiation therapy within the last 1-12 months.
• Have a functional capacity rating of 70 or greater on the Karnofsky Performance Scale or a rating of 1 or 0 on the ECOG scale when assessed by a medical oncologist (or physicians designee) following cancer treatments
• Have a caregiver willing to participate int he study
• Be able to read English
• Be 21 years of age or older
• Give written informed consent

Inclusion Criteria for Caregivers:

• Be nominated by a cancer survivor
• Be able to read English
• Be 21 years of age or older
• Give written informed consent

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Individual Exercise Intervention; Survivor-only progressive walking and resistance exercise	Behavioral: Survivor-only progressive walking and resistance exercise; Daily, home-based, tailored exercise program delivered over the course of 6 weeks to the survivor only; Other Names: EXCAP
Experimental: Dyadic Exercise Intervention; Dyadic progressive walking and resistance exercise	Behavioral: Dyadic progressive walking and resistance exercise; Daily, home-based, tailored exercise program delivered over the course of 6 weeks to the survivor and caregiver as a dyad; Other Names: EXCAP-PA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological Distress	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.	Baseline to post-intervention (6 weeks later)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immune Biomarkers	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.	Baseline to post-intervention (6 weeks later)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provision of Social Support	Change in provision of social support from baseline to 6 weeks as reported by the cancer survivor was measured by the Dyadic Support Questionnaire (DSQ). At each time point (baseline and 6 weeks), this questionnaire had a total score range of 0-45, with higher scores signifying more support. We subtracted the baseline score from the 6 week DSQ score; the change score reported below thus has a range from -45 to 45, with higher scores signifying more support.	Baseline to post-intervention (6 weeks later)

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: Charles Kamen, PhD, University of Rochester

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: June 5, 2013
• First Submitted That Met QC Criteria: June 18, 2013
• First Posted (Estimate): June 21, 2013

Study Record Updates

• Last Update Posted (Estimate): February 5, 2016
• Last Update Submitted That Met QC Criteria: January 8, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 46413