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

NCT01324102 | Completed Phase 1 Results

• 1 other identifier: D7629-P
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms

Keywords

Neoplasms

Outcome Measures

Primary Outcomes (1)

• Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials.

  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).

  Primary outcome is measured at baseline and after the 8 week yoga intervention.

Study Arms (2)

1. Yoga therapy

ACTIVE COMPARATOR

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

2. Wait list

NO INTERVENTION

The comparative intervention is an 8 week wait list control group for which there is no intervention provided within the study protocol.

Interventions

Yoga therapy 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.

1. Yoga therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cancer treated in the past 3 years

You may not qualify if:

• Dementia
• Psychotic Disorder
• In hospice care

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Wake Forest University Health Sciences: collaborator

Study Sites (1)

VA Boston Healthcare System Brockton Campus, Brockton, MA

Brockton, Massachusetts, 02301, United States

Location

Related Publications (2)

• 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.

  PMID: 16374892 BACKGROUND

• 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.

  PMID: 18544284 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Limitations and Caveats

The goals of this study were modest. A small pilot pre-post randomized trial was completed with a Yoga therapy intervention and a Wait list intervention. Additional studies in larger samples are needed.

Results Point of Contact

• Title: Jennifer Moye
• Organization: VA Boston Healthcare System

jennifer.moye@va.gov

774-826-3721

Study Officials

• Jennifer Ann Moye, PhD

  VA Boston Healthcare System Brockton Campus, Brockton, MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2011
• First Posted: March 28, 2011
• Study Start: May 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: December 1, 2015
• Last Updated: January 1, 2016
• Results First Posted: May 22, 2015

Record last verified: 2015-12

Locations

US (1)