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
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms||Behavioral: Yoga therapy||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Yoga Cancer Rehabilitation Study|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||December 2015|
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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01324102
|United States, Massachusetts|
|VA Boston Healthcare System Brockton Campus, Brockton, MA|
|Brockton, Massachusetts, United States, 02301|
|Principal Investigator:||Jennifer Ann Moye, PhD||VA Boston Healthcare System Brockton Campus, Brockton, MA|