YogaCares: Yoga Cancer Rehabilitation Study: A Randomized Trial of Adaptive Yoga for Older Cancer Survivors
Study Details
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 |
|---|---|---|
|
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
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
- Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials. [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
Criteria
Inclusion Criteria:
- Cancer treated in the past 3 years
Exclusion Criteria:
-
Dementia
-
Psychotic Disorder
-
In hospice care
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.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.
- D7629-P
Study Results
Participant Flow
| Recruitment Details | Participants identified through cancer registry who were: diagnosed with cancer (any type) Stage 1-4 within the past three years; received surgery, chemotherapy, or radiation treatment; no psychotic or dementing disorders; and not currently in hospice care. |
|---|---|
| Pre-assignment Detail | No participants were excluded prior to assignment. |
| Arm/Group Title | Yoga Therapy Intervention | Wait List Control |
|---|---|---|
| Arm/Group Description | Intervention Yoga therapy received an 8 week 2x weekly Yoga therapy class. | Wait List control received no intervention for 8 weeks, then joined the yoga group |
| Period Title: Overall Study | ||
| STARTED | 11 | 12 |
| COMPLETED | 10 | 6 |
| NOT COMPLETED | 1 | 6 |
Baseline Characteristics
| Arm/Group Title | Yoga Therapy Intervention | Wait List Control | Total |
|---|---|---|---|
| Arm/Group Description | Intervention: Yoga therapy was 8 week class for two times per week | Wait List control: The wait list control did not receive an intervention. | Total of all reporting groups |
| Overall Participants | 11 | 12 | 23 |
| Age, Customized (Years) [Mean (Full Range) ] | |||
| Mean |
69.42
|
69.42
|
69.42
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
1
9.1%
|
0
0%
|
1
4.3%
|
| Male |
10
90.9%
|
12
100%
|
22
95.7%
|
| Race/Ethnicity, Customized (participants) [Number] | |||
| Caucasian |
10
90.9%
|
11
91.7%
|
21
91.3%
|
| All other |
1
9.1%
|
1
8.3%
|
2
8.7%
|
Outcome Measures
| Title | Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials. |
|---|---|
| Description | 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). |
| Time Frame | Primary outcome is measured at baseline and after the 8 week yoga intervention. |
Outcome Measure Data
| Analysis Population Description |
|---|
| This is a small scale pilot study. Due to small sample size, we did pre-post analysis of the total groups, separated by those with and without initial impairment. |
| Arm/Group Title | Pre Group Values | Post Group Values |
|---|---|---|
| Arm/Group Description | Patient Reported Outcome Measurement System values for all participants prior to participation in 8 session Yoga Therapy with home practice | Patient Reported Outcome Measurement System values for all participants after participation in 8 session Yoga Therapy with home practice |
| Measure Participants | 23 | 23 |
| Anxiety within normal limits at start (n=18) |
8.90
|
12.26
|
| Anxiety impaired at start (n=5) |
19.80
|
16.80
|
| Insomnia within normal limits at start (n=16) |
12.41
|
13.00
|
| Insomnia impaired at start (n=7) |
23.14
|
18.14
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pre Group Values, Post Group Values |
|---|---|---|
| Comments | Repeated measure Analysis of Variance (ANOVA) with null hypothesis of no group differences, comparing anxiety scores pre-Yoga versus post-Yoga, between the two groups for changes in anxiety. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .004 |
| Comments | The a priori threshold for statistical significance is .05. The .004 value exceeds this value. There was only one comparison, so there was no adjustment for multiple comparison. This analysis refers to the row and category of anxiety. | |
| Method | ANOVA | |
| Comments | F=10.25 | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pre Group Values, Post Group Values |
|---|---|---|
| Comments | Repeated measure Analysis of Variance (ANOVA) with null hypothesis of no group differences, comparing insomnia scores pre-Yoga versus post-Yoga, between the two groups. This measures changes in insomnia. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .056 |
| Comments | F=4.07. The a priori threshold for statistical significance is .05. The .056 value does not exceed it. There was only one comparison, so there was no adjustment for multiple comparison. This analysis refers to the row/category of insomnia. | |
| Method | ANOVA | |
| Comments | ||
Adverse Events
| Time Frame | We collected "serious adverse event and other (not including serious) adverse event" information from the beginning of the study period to 3 months post study period for a total of 5 months. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | During the collection period, two forms were submitted to the Institutional Review Board for review as required. One participant in the Arm 1, Yoga therapy, age 80, was hospitalized. His principal diagnosis was influenza. One participant in the Arm 2, Wait list, age 65, was hospitalized. His principal diagnosis was pneumonia. | |||||
| Arm/Group Title | Yoga Therapy | Wait List | Wait List on Yoga Therapy | |||
| Arm/Group Description | Received yoga therapy. One participant in the Arm 1, Yoga therapy, age 80, was hospitalized. His principal diagnosis was influenza. | Received no yoga therapy for 8 weeks while the intervention group received yoga therapy One participant in the Arm 2, Wait list, age 65, was hospitalized. His principal diagnosis was pneumonia. | Received yoga therapy after an 8 week wait. No participants were hospitalized. | |||
All Cause Mortality |
||||||
| Yoga Therapy | Wait List | Wait List on Yoga Therapy | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Yoga Therapy | Wait List | Wait List on Yoga Therapy | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/11 (0%) | 0/12 (0%) | 0/12 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Yoga Therapy | Wait List | Wait List on Yoga Therapy | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/11 (9.1%) | 1/12 (8.3%) | 0/12 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Influenza Unrelated Hospitalization | 1/11 (9.1%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
| Pneumonia Unrelated Hospitalization | 0/11 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Jennifer Moye |
|---|---|
| Organization | VA Boston Healthcare System |
| Phone | 774-826-3721 |
| jennifer.moye@va.gov |
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