Exercise Intervention for Cancer Survivors and Caregivers

Cancer Clinical Trial

Official title:

Dyadic Exercise Intervention for Cancer Survivors and Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01883635
• Other study ID #: 46413
• Status: Completed
• Phase: Phase 1
• First received: June 5, 2013
• Last updated: January 8, 2016
• Start date: May 2013
• Est. completion date: August 2015

Study information

• Verified date: January 2016
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

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
• 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

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	No
Primary	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)	No
Secondary	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)	No