Yoga Cancer Rehabilitation Study
18 Years
N/A
Both
Neoplasms
Trial Information
Yoga Cancer Rehabilitation Study
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 domain, 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.
Inclusion Criteria:
- Cancer treated in the past 3 years
Exclusion Criteria:
- Dementia
- Psychotic Disorder
- In hospice care
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Patient-Reported Outcomes Measurement System (PROMIS) scale, a scale developed by NIH to assess outcomes across different trials.
Outcome Description:
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.
Outcome Time Frame:
Primary outcome is measured at baseline and after the 8 week yoga intervention.
Safety Issue:
No
Principal Investigator
Jennifer Ann Moye, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
VA Boston Healthcare System, Brockton Campus
Authority:
United States: Federal Government
Study ID:
D7629-P
NCT ID:
NCT01324102
Start Date:
May 2011
Completion Date:
April 2013
Related Keywords:
- Neoplasms
- Neoplasms
- Neoplasms
Name | Location |
|---|---|
| VA Boston Healthcare System, Brockton Campus | Brockton, Massachusetts 02301 |
