Yoga Cancer Rehabilitation Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Wake Forest School of Medicine
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01324102
First received: March 4, 2011
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

With advances in the detection and treatment of cancer, there are now 11 million cancer survivors in the U.S., 500,000 of whom are veterans treated in VHA. The mental and physical health consequences of cancer and its treatment may affect a veteran's functioning and re-integration back into family, work, and daily life. Recent studies suggest that yoga may be an effective intervention for improving both the physical and mental health of individuals after cancer, although this has not been studied in veterans. This study has three components: (1) Determine factors that increase participation in Yoga by veterans using individual interviews and focus group; (2) Create a Yoga protocol for veterans adapted from an existing empirically supported treatment, akin to a phase 1 clinical trial for safety and tolerability; (3) Evaluate the efficacy of Yoga for improving fatigue, insomnia, anxiety, and depression after treatment for colorectal cancer, akin to a phase 2 trial with randomization.


Condition Intervention Phase
Neoplasms
Behavioral: Yoga
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Yoga Cancer Rehabilitation Study

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Patient-Reported Outcomes Measurement System (PROMIS) scale, a scale developed by NIH to assess outcomes across different trials. [ Time Frame: Primary outcome is measured at baseline and after the 8 week yoga intervention. ] [ Designated as safety issue: No ]
    The investigators will use the Patient-Reported Outcomes Measurement System (PROMIS) (www.nihpromis.org) scale to measure changes in scale levels of Depression, Anxiety, Fatigue, Sleep Disturbance before and after the intervention. This is measured at baseline, and to assess for change, after the 8 week yoga intervention. This same measure is repeated 12 weeks later to assess changes in these scale levels after an additional time period, to see if the improvements are sustained.


Enrollment: 38
Study Start Date: May 2011
Estimated Study Completion Date: April 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Intervention
Behavioral: Yoga
For the second aim of the study, 16 individuals will complete a yoga intervention in a non-randomized trial to establish safe procedures for yoga for an older post colorectal cancer veteran population.
No Intervention: Arm 2
Wait List

Detailed Description:

With a 1 and 2 lifetime risk of diagnosis, cancer is a highly prevalent disease. Cancer and its treatment are associated with long term mental and physical side effects that impair physical, vocational, and social role functioning. In order to provide excellent care for veterans, rehabilitative strategies to improve mental and physical health after cancer treatment need empirical study. The objective of the proposed pilot project is to create a Veterans' Yoga Rehabilitation Program (VYRP) for cancer survivors who receive care in VHA, that is based on an existing evidence based protocol which is systemically adapted, marketed, and tested in a veteran population, with 3 aims:

Aim 1: Enhancing Acceptability To determine factors that will increase participation in the VYRP in VHA patients after treatment for cancer, who are primarily male and older than age 60.

Aim 2: Adapting to Veterans To create the VYRP protocol by adapting an empirically supported Yoga protocol to the needs of veterans.

Aim 3: Evaluating Efficacy To evaluate the efficacy of the VYRP for improving health related quality of life in four domains, and, to determine if efficacy varies as a function of patient age or pre-existing PTSD. The long term goal is to develop an evidence based mind-body Yoga intervention to support healing and restore function in VHA patients for use after treatment for cancer.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cancer treated in the past 3 years

Exclusion Criteria:

  • Dementia
  • Psychotic Disorder
  • In hospice care
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01324102

Locations
United States, Massachusetts
VA Boston Healthcare System, Brockton Campus
Brockton, Massachusetts, United States, 02301
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Jennifer Ann Moye, PhD VA Boston Healthcare System, Brockton Campus
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01324102     History of Changes
Other Study ID Numbers: D7629-P
Study First Received: March 4, 2011
Last Updated: March 10, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Neoplasms

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014