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Completed

NCT Number: NCT01883635

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.

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Key information

Conditions

Cancer Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Rochester

Rochester, New York, 14642, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survivor-only progressive walking and resistance exercise

Behavioral

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

Other names: EXCAP

Dyadic progressive walking and resistance exercise

Behavioral

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

Primary outcomes

  1. 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

  1. Immune Biomarkers

    Time frame: 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.

Other outcomes

  1. Provision of Social Support

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

    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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

Dyadic Exercise Intervention for Cancer Survivors and Caregivers

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 21, 2013
Registry last updated
Feb 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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