Exercise Intervention for Cancer Survivors and Caregivers

NCT01883635 | Completed Phase 1 Results DMC

• 1 other identifier: 46413
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Immune Biomarkers

  Baseline to post-intervention (6 weeks later)

Other Outcomes (1)

• Provision of Social Support

  Baseline to post-intervention (6 weeks later)

Study Arms (2)

Individual Exercise Intervention

ACTIVE COMPARATOR

Survivor-only progressive walking and resistance exercise

Behavioral: Survivor-only progressive walking and resistance exercise

Dyadic Exercise Intervention

EXPERIMENTAL

Dyadic progressive walking and resistance exercise

Behavioral: Dyadic progressive walking and resistance exercise

Interventions

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

Also known as: EXCAP

Individual Exercise Intervention

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

Also known as: EXCAP-PA

Dyadic Exercise Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Neoplasms

Limitations and Caveats

First, this was a pilot, Phase I trial, and hence had a limited sample size. This study was conducted in a single geographic region. Finally, we analyzed only two time points: baseline and post-intervention.

Results Point of Contact

• Title: Dr. Charles Kamen
• Organization: University of Rochester

charles_kamen@urmc.rochester.edu

585-275-9958

Study Officials

• Charles Kamen, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Professor

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 21, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: August 1, 2015
• Last Updated: February 5, 2016
• Results First Posted: November 30, 2015

Record last verified: 2016-01

Locations

US (1)