Trial Outcomes & Findings for Yoga Cancer Rehabilitation Study: A Randomized Trial of Adaptive Yoga for Older Cancer Survivors (NCT NCT01324102)
NCT ID: NCT01324102
Last Updated: 2016-01-01
Results Overview
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).
COMPLETED
PHASE1/PHASE2
23 participants
Primary outcome is measured at baseline and after the 8 week yoga intervention.
2016-01-01
Participant Flow
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.
No participants were excluded prior to assignment.
Participant milestones
| Measure |
Yoga Therapy Intervention
Intervention
Yoga therapy received an 8 week 2x weekly Yoga therapy class.
|
Wait List Control
Wait List control received no intervention for 8 weeks, then joined the yoga group
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
|
Overall Study
COMPLETED
|
10
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
Reasons for withdrawal
| Measure |
Yoga Therapy Intervention
Intervention
Yoga therapy received an 8 week 2x weekly Yoga therapy class.
|
Wait List Control
Wait List control received no intervention for 8 weeks, then joined the yoga group
|
|---|---|---|
|
Overall Study
illness
|
1
|
6
|
Baseline Characteristics
Yoga Cancer Rehabilitation Study: A Randomized Trial of Adaptive Yoga for Older Cancer Survivors
Baseline characteristics by cohort
| Measure |
Yoga Therapy Intervention
n=11 Participants
Intervention: Yoga therapy was 8 week class for two times per week
|
Wait List Control
n=12 Participants
Wait List control: The wait list control did not receive an intervention.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Mean
|
69.42 Years
n=5 Participants
|
69.42 Years
n=7 Participants
|
69.42 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
All other
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Primary outcome is measured at baseline and after the 8 week yoga intervention.Population: 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.
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).
Outcome measures
| Measure |
Pre Group Values
n=23 Participants
Patient Reported Outcome Measurement System values for all participants prior to participation in 8 session Yoga Therapy with home practice
|
Post Group Values
n=23 Participants
Patient Reported Outcome Measurement System values for all participants after participation in 8 session Yoga Therapy with home practice
|
|---|---|---|
|
Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials.
Anxiety within normal limits at start (n=18)
|
8.90 units on a scale
Interval 6.0 to 19.0
|
12.26 units on a scale
Interval 6.0 to 24.0
|
|
Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials.
Anxiety impaired at start (n=5)
|
19.80 units on a scale
Interval 17.0 to 24.0
|
16.80 units on a scale
Interval 11.0 to 21.0
|
|
Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials.
Insomnia within normal limits at start (n=16)
|
12.41 units on a scale
Interval 7.0 to 20.0
|
13.00 units on a scale
Interval 6.0 to 30.0
|
|
Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials.
Insomnia impaired at start (n=7)
|
23.14 units on a scale
Interval 21.0 to 30.0
|
18.14 units on a scale
Interval 12.0 to 26.0
|
Adverse Events
Yoga Therapy
Wait List
Wait List on Yoga Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Yoga Therapy
n=11 participants at risk
Received yoga therapy.
One participant in the Arm 1, Yoga therapy, age 80, was hospitalized. His principal diagnosis was influenza.
|
Wait List
n=12 participants at risk
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.
|
Wait List on Yoga Therapy
n=12 participants at risk
Received yoga therapy after an 8 week wait.
No participants were hospitalized.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Influenza Unrelated Hospitalization
|
9.1%
1/11 • Number of events 1 • 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.
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.
|
0.00%
0/12 • 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.
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.
|
0.00%
0/12 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Unrelated Hospitalization
|
0.00%
0/11 • 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.
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.
|
8.3%
1/12 • Number of events 1 • 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.
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.
|
0.00%
0/12 • 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.
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place