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

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ClinicalTrials.gov Identifier: NCT01324102
Recruitment Status : Completed
First Posted : March 28, 2011
Results First Posted : May 22, 2015
Last Update Posted : January 1, 2016
Sponsor:
Collaborator:
Wake Forest University Health Sciences
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neoplasms
Intervention Behavioral: Yoga therapy
Enrollment 23

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 Details No participants were excluded prior to assignment.
Arm/Group Title Yoga Therapy Intervention Wait List Control
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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 [1] 12 [2]
Completed 10 6
Not Completed 1 6
Reason Not Completed
illness             1             6
[1]
Yoga groups 3 and 5 (not including pre-randomization group)
[2]
Yoga group 4 and 6
Arm/Group Title Yoga Therapy Intervention Wait List Control Total
Hide 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 Number of Baseline Participants 11 12 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Mean (Full Range)
Unit of measure:  Years
Mean Number Analyzed 11 participants 12 participants 23 participants
69.42
(55 to 84)
69.42
(55 to 84)
69.42
(55 to 84)
[1]
Measure Description: Adult individuals of any age were permitted, but since most of those diagnosed with cancer are older, the sample is predominantly older.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 23 participants
Female
1
   9.1%
0
   0.0%
1
   4.3%
Male
10
  90.9%
12
 100.0%
22
  95.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 23 participants
Caucasian 10 11 21
All other 1 1 2
1.Primary Outcome
Title Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials.
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
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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
Overall Number of Participants Analyzed 23 23
Mean (Full Range)
Unit of Measure: units on a scale
Anxiety within normal limits at start (n=18)
8.90
(6 to 19)
12.26
(6 to 24)
Anxiety impaired at start (n=5)
19.80
(17 to 24)
16.80
(11 to 21)
Insomnia within normal limits at start (n=16)
12.41
(7 to 20)
13.00
(6 to 30)
Insomnia impaired at start (n=7)
23.14
(21 to 30)
18.14
(12 to 26)
Show Statistical Analysis 1 Hide 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 [Not Specified]
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
Show Statistical Analysis 2 Hide 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 [Not Specified]
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 [Not Specified]
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
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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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide 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 (0.00%)      0/12 (0.00%)      0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Yoga Therapy Wait List Wait List on Yoga Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/11 (9.09%)      1/12 (8.33%)      0/12 (0.00%)    
Respiratory, thoracic and mediastinal disorders       
Influenza Unrelated Hospitalization  1 [1]  1/11 (9.09%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Pneumonia Unrelated Hospitalization  2 [2]  0/11 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, Other adverse events
2
Term from vocabulary, other adverse event
[1]
One participant in the Arm 1, Yoga therapy, age 80, was hospitalized for influenza. The reportable event is hospitalization, hence I am listing an Unrelated Hospitalization for Influenza.
[2]
One participant in the Arm 2, Wait list, age 65, was hospitalized for pneumonia. The reportable event is hospitalization, hence I am listing an Unrelated Hospitalization for Pneumonia
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jennifer Moye
Organization: VA Boston Healthcare System
Phone: 774-826-3721
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01324102     History of Changes
Other Study ID Numbers: D7629-P
First Submitted: March 4, 2011
First Posted: March 28, 2011
Results First Submitted: December 2, 2014
Results First Posted: May 22, 2015
Last Update Posted: January 1, 2016