Exercise Intervention for Cancer Survivors and Caregivers

University of Rochester44 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cancer

Interventions

Survivor-only progressive walking and resistance exerciseBEHAVIORAL

Daily, home-based, tailored exercise program delivered over the course of 6 weeks to the survivor only

Dyadic progressive walking and resistance exerciseBEHAVIORAL

Daily, home-based, tailored exercise program delivered over the course of 6 weeks to the survivor and caregiver as a dyad

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Rochester

Rochester, New York, United States

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

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

Data from ClinicalTrials.gov

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