Exercise Intervention for Cancer Survivors and Caregivers

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

Official Title
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Dyadic Exercise Intervention for Cancer Survivors and Caregivers

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Survivor-only progressive walking and resistance exercise
* Behavioral: Dyadic progressive walking and resistance exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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) |