Yoga Cancer Rehabilitation Study: A Randomized Trial of Adaptive Yoga for Older Cancer Survivors (YogaCares)

• ClinicalTrials.gov Identifier: NCT01324102
• Recruitment Status: Completed
• First Posted: March 28, 2011
• Results First Posted: May 22, 2015
• Last Update Posted: January 1, 2016
• Sponsor: VA Office of Research and Development
• Collaborator: Wake Forest University Health Sciences
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

Brief Summary:

With advances in the detection and treatment of cancer, there are now 14 million cancer survivors in the U.S., 500,000 of whom are treated in the Veterans Health Administration. 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 or disease	Intervention/treatment	Phase
Neoplasms	Behavioral: Yoga therapy	Phase 1; Phase 2

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 for cancer survivors who receive care in the Veterans Health Administration, 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 Yoga in Veterans after treatment for cancer, who are primarily male and older than age 60.

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

Aim 3: Evaluating Efficacy To evaluate the efficacy of the Yoga protocol 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 Post Traumatic Stress Disorder. The long term goal is to develop an evidence based mind-body Yoga intervention to support healing and restore function in Veterans Health Administration patients for use after treatment for cancer.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Yoga Cancer Rehabilitation Study
• Study Start Date: May 2011
• Actual Primary Completion Date: April 2013
• Actual Study Completion Date: December 2015

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1. Yoga therapy; The intervention is an 8 week Yoga therapy class adapted to the specific needs of the veteran. The class meets two times per weeks for 90 minutes. A series of poses are instructed, with adaptations used as provided by a physical therapist.	Behavioral: Yoga therapy; For the second aim of the study, individuals will complete an 8 week yoga intervention in a non-randomized trial to establish safe procedures for yoga for an older post colorectal cancer veteran population.
No Intervention: 2. Wait list; The comparative intervention is an 8 week wait list control group for which there is no intervention provided within the study protocol.

Outcome Measures

Primary Outcome Measures :

1. Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials. [ Time Frame: Primary outcome is measured at baseline and after the 8 week yoga intervention. ]
   The investigators will use the Patient-Reported Outcomes Measurement System which can be found on the National Institutes of Health website. It measures changes in scale levels of Depression, Anxiety, Fatigue, Sleep Disturbance before and after the intervention. The measure is developed by National Institutes of Health to permit comparison across studies, and is reliable and valid. This is measured at baseline, and to assess for change, after the 8 week yoga intervention. There are six items in each subscale with four points each, with a range from 1-5. The full subscale range is 6-30. Anxiety was assessed by anxiety subscale, ranging from 6 ( no anxiety) to 30 (worst possible anxiety); Insomnia was assessed by the anxiety subscale, ranging from 6 ( no anxiety) to 30 (worst possible anxiety).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Massachusetts

VA Boston Healthcare System Brockton Campus, Brockton, MA

Brockton, Massachusetts, United States, 02301

Sponsors and Collaborators

VA Office of Research and Development

Wake Forest University Health Sciences

Investigators

• Principal Investigator: Jennifer Ann Moye, PhD; VA Boston Healthcare System Brockton Campus, Brockton, MA

More Information

Publications:

Culos-Reed SN, Carlson LE, Daroux LM, Hately-Aldous S. A pilot study of yoga for breast cancer survivors: physical and psychological benefits. Psychooncology. 2006 Oct;15(10):891-7.

Danhauer SC, Tooze JA, Farmer DF, Campbell CR, McQuellon RP, Barrett R, Miller BE. Restorative yoga for women with ovarian or breast cancer: findings from a pilot study. J Soc Integr Oncol. 2008 Spring;6(2):47-58.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01324102
• Other Study ID Numbers: D7629-P
• First Posted: March 28, 2011
• Results First Posted: May 22, 2015
• Last Update Posted: January 1, 2016
• Last Verified: December 2015

Keywords provided by VA Office of Research and Development:

Neoplasms

Additional relevant MeSH terms:

Neoplasms