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

NCT ID: NCT01324102

Last Updated: 2016-01-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2015-12-31

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.

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.

Conditions

Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Yoga therapy

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Cancer treated in the past 3 years

Exclusion Criteria

• Dementia
• Psychotic Disorder
• In hospice care

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Ann Moye, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Boston Healthcare System Brockton Campus, Brockton, MA

Locations

VA Boston Healthcare System Brockton Campus, Brockton, MA

Brockton, Massachusetts, United States

Countries

United States

References

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. doi: 10.1002/pon.1021.

Reference Type: BACKGROUND

PMID: 16374892 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18544284 (View on PubMed)

Other Identifiers

D7629-P

Identifier Type: -

Identifier Source: org_study_id