Trial Outcomes & Findings for Yoga in Treating Sleep Disturbance in Cancer Survivors (NCT NCT00397930)
NCT ID: NCT00397930
Last Updated: 2017-02-20
Results Overview
Pittsburgh Sleep Quality Index: Measures sleep disturbance and usual sleep habits during the prior month only using seven clinically derived domains of sleep difficulties: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Global PSQI is a summary of the seven domains. Each Domain is scored from 0 to 3, therefore PSQI has a range of 0 (better) to 21 (worse). Interpretation of the PSQI is that a score less than 5 is associated with good sleep quality and a score of 5 or greater is associated with poor sleep quality. PSQI was calculated at both pre- and post-intervention for both arms. Pre-intervention PSQI was recorded during the week immediately before commencing the 4-week intervention. Post-intervention PSQI was recorded during the week immediately following the intervention. Mean post-pre change was calculated for both arms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
410 participants
Primary outcome timeframe
2-24 months after surgery, chemotherapy, and/or radiation therapy
Results posted on
2017-02-20
Participant Flow
Participant milestones
| Measure |
Yoga Intervention (YOCAS)
The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.
fatigue assessment and management
management of therapy complications
quality-of-life assessment
sleep disorder therapy
yoga therapy
|
Standard Care Control Condition
The control condition used a standard care format. Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.
fatigue assessment and management
management of therapy complications
quality-of-life assessment
|
|---|---|---|
|
Overall Study
STARTED
|
206
|
204
|
|
Overall Study
COMPLETED
|
168
|
153
|
|
Overall Study
NOT COMPLETED
|
38
|
51
|
Reasons for withdrawal
| Measure |
Yoga Intervention (YOCAS)
The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.
fatigue assessment and management
management of therapy complications
quality-of-life assessment
sleep disorder therapy
yoga therapy
|
Standard Care Control Condition
The control condition used a standard care format. Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.
fatigue assessment and management
management of therapy complications
quality-of-life assessment
|
|---|---|---|
|
Overall Study
Personal reasons
|
14
|
8
|
|
Overall Study
Other medical
|
9
|
4
|
|
Overall Study
Unknown reasons
|
9
|
14
|
|
Overall Study
Noncompliant
|
3
|
2
|
|
Overall Study
Too time-consuming
|
2
|
9
|
|
Overall Study
Started own yoga program
|
1
|
1
|
|
Overall Study
Did not want to be in control group
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
8
|
|
Overall Study
Missing data
|
0
|
4
|
Baseline Characteristics
Yoga in Treating Sleep Disturbance in Cancer Survivors
Baseline characteristics by cohort
| Measure |
Yoga Intervention (YOCAS)
n=206 Participants
The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.
fatigue assessment and management
management of therapy complications
quality-of-life assessment
sleep disorder therapy
yoga therapy
|
Standard Care Control Condition
n=204 Participants
The control condition used a standard care format. Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.
fatigue assessment and management
management of therapy complications
quality-of-life assessment
|
Total
n=410 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
54.3 years
STANDARD_DEVIATION 11.05 • n=99 Participants
|
54 years
STANDARD_DEVIATION 9.57 • n=107 Participants
|
54.1 years
STANDARD_DEVIATION 10.33 • n=206 Participants
|
|
Gender
Female
|
197 Participants
n=99 Participants
|
196 Participants
n=107 Participants
|
393 Participants
n=206 Participants
|
|
Gender
Male
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
197 participants
n=99 Participants
|
186 participants
n=107 Participants
|
383 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
8 participants
n=99 Participants
|
16 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
206 participants
n=99 Participants
|
204 participants
n=107 Participants
|
410 participants
n=206 Participants
|
|
Currently employed
Yes
|
168 participants
n=99 Participants
|
155 participants
n=107 Participants
|
323 participants
n=206 Participants
|
|
Currently employed
No
|
38 participants
n=99 Participants
|
49 participants
n=107 Participants
|
87 participants
n=206 Participants
|
|
Marital status
Married or long-term committed relationship
|
145 participants
n=99 Participants
|
143 participants
n=107 Participants
|
288 participants
n=206 Participants
|
|
Marital status
Divorced or separated
|
28 participants
n=99 Participants
|
32 participants
n=107 Participants
|
60 participants
n=206 Participants
|
|
Marital status
Single
|
18 participants
n=99 Participants
|
17 participants
n=107 Participants
|
35 participants
n=206 Participants
|
|
Marital status
Widowed
|
6 participants
n=99 Participants
|
12 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Marital status
Unknown
|
9 participants
n=99 Participants
|
0 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Education
Completed 4 years of college or more
|
96 participants
n=99 Participants
|
93 participants
n=107 Participants
|
189 participants
n=206 Participants
|
|
Education
Completed < 4 years of college
|
72 participants
n=99 Participants
|
69 participants
n=107 Participants
|
141 participants
n=206 Participants
|
|
Education
High school graduate
|
33 participants
n=99 Participants
|
36 participants
n=107 Participants
|
69 participants
n=206 Participants
|
|
Education
Less than a high school graduate
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Education
Unknown
|
3 participants
n=99 Participants
|
5 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Cancer type
Breast
|
152 participants
n=99 Participants
|
157 participants
n=107 Participants
|
309 participants
n=206 Participants
|
|
Cancer type
Hematologic
|
16 participants
n=99 Participants
|
14 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
Cancer type
Gynecologic
|
11 participants
n=99 Participants
|
8 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Cancer type
Alimentary
|
7 participants
n=99 Participants
|
17 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Cancer type
Other
|
20 participants
n=99 Participants
|
8 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Cancer stage
0
|
11 participants
n=99 Participants
|
10 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
Cancer stage
I
|
66 participants
n=99 Participants
|
79 participants
n=107 Participants
|
145 participants
n=206 Participants
|
|
Cancer stage
II
|
71 participants
n=99 Participants
|
66 participants
n=107 Participants
|
137 participants
n=206 Participants
|
|
Cancer stage
III
|
32 participants
n=99 Participants
|
32 participants
n=107 Participants
|
64 participants
n=206 Participants
|
|
Cancer stage
IV
|
7 participants
n=99 Participants
|
4 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Cancer stage
Unknown
|
19 participants
n=99 Participants
|
13 participants
n=107 Participants
|
32 participants
n=206 Participants
|
|
Previous treatment - Surgery
Yes
|
183 participants
n=99 Participants
|
181 participants
n=107 Participants
|
364 participants
n=206 Participants
|
|
Previous treatment - Surgery
No
|
23 participants
n=99 Participants
|
23 participants
n=107 Participants
|
46 participants
n=206 Participants
|
|
Previous Treatment - Chemotherapy
Yes
|
145 participants
n=99 Participants
|
139 participants
n=107 Participants
|
284 participants
n=206 Participants
|
|
Previous Treatment - Chemotherapy
No
|
61 participants
n=99 Participants
|
65 participants
n=107 Participants
|
126 participants
n=206 Participants
|
|
Previous Treatment - Radiation therapy
Yes
|
137 participants
n=99 Participants
|
129 participants
n=107 Participants
|
266 participants
n=206 Participants
|
|
Previous Treatment - Radiation therapy
No
|
69 participants
n=99 Participants
|
75 participants
n=107 Participants
|
144 participants
n=206 Participants
|
|
Previous Treatment - Hormone treatment
Yes
|
13 participants
n=99 Participants
|
15 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Previous Treatment - Hormone treatment
No
|
193 participants
n=99 Participants
|
189 participants
n=107 Participants
|
382 participants
n=206 Participants
|
|
Current hormone therapy
Yes
|
99 participants
n=99 Participants
|
107 participants
n=107 Participants
|
206 participants
n=206 Participants
|
|
Current hormone therapy
Unknown
|
107 participants
n=99 Participants
|
97 participants
n=107 Participants
|
204 participants
n=206 Participants
|
|
Time since first treatment for cancer
|
14.9 months
STANDARD_DEVIATION 7.18 • n=99 Participants
|
17.7 months
STANDARD_DEVIATION 23.00 • n=107 Participants
|
16.3 months
STANDARD_DEVIATION 17.00 • n=206 Participants
|
|
Karnofsky performance status
|
86.9 Karnofsky performance scale
STANDARD_DEVIATION 33.15 • n=99 Participants
|
87.8 Karnofsky performance scale
STANDARD_DEVIATION 32.00 • n=107 Participants
|
87.4 Karnofsky performance scale
STANDARD_DEVIATION 32.6 • n=206 Participants
|
|
Exercise stage of change
Not exercising and do not intend to in next 6 mo
|
8 participants
n=99 Participants
|
10 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Exercise stage of change
Not exercising but intend to in next 6 mo
|
43 participants
n=99 Participants
|
38 participants
n=107 Participants
|
81 participants
n=206 Participants
|
|
Exercise stage of change
Not exercising but intend to begin in next 30 days
|
45 participants
n=99 Participants
|
50 participants
n=107 Participants
|
95 participants
n=206 Participants
|
|
Exercise stage of change
Exercising and have been for less than 6 months
|
44 participants
n=99 Participants
|
43 participants
n=107 Participants
|
87 participants
n=206 Participants
|
|
Exercise stage of change
Exercising and have been for more than 6 months
|
62 participants
n=99 Participants
|
58 participants
n=107 Participants
|
120 participants
n=206 Participants
|
|
Exercise stage of change
Unknown
|
4 participants
n=99 Participants
|
5 participants
n=107 Participants
|
9 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2-24 months after surgery, chemotherapy, and/or radiation therapyPittsburgh Sleep Quality Index: Measures sleep disturbance and usual sleep habits during the prior month only using seven clinically derived domains of sleep difficulties: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Global PSQI is a summary of the seven domains. Each Domain is scored from 0 to 3, therefore PSQI has a range of 0 (better) to 21 (worse). Interpretation of the PSQI is that a score less than 5 is associated with good sleep quality and a score of 5 or greater is associated with poor sleep quality. PSQI was calculated at both pre- and post-intervention for both arms. Pre-intervention PSQI was recorded during the week immediately before commencing the 4-week intervention. Post-intervention PSQI was recorded during the week immediately following the intervention. Mean post-pre change was calculated for both arms.
Outcome measures
| Measure |
Yoga Intervention (YOCAS)
n=168 Participants
The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.
fatigue assessment and management
management of therapy complications
quality-of-life assessment
sleep disorder therapy
yoga therapy
|
Standard Care Control Condition
n=153 Participants
The control condition used a standard care format. Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.
fatigue assessment and management
management of therapy complications
quality-of-life assessment
|
|---|---|---|
|
Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI)
|
-1.96 units on a scale
Standard Error 0.25
|
-1.07 units on a scale
Standard Error 0.23
|
Adverse Events
Yoga Intervention (YOCAS)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care Control Condition
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Yoga Intervention (YOCAS)
n=206 participants at risk
The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.
fatigue assessment and management
management of therapy complications
quality-of-life assessment
sleep disorder therapy
yoga therapy
|
Standard Care Control Condition
n=204 participants at risk
The control condition used a standard care format. Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.
fatigue assessment and management
management of therapy complications
quality-of-life assessment
|
|---|---|---|
|
General disorders
Death
|
0.49%
1/206
|
0.00%
0/204
|
|
Metabolism and nutrition disorders
Death
|
0.00%
0/206
|
0.49%
1/204
|
Other adverse events
Adverse event data not reported
Additional Information
Charles E. Heckler, PhD, MS. Research Assistant Professor
University of Rochester Medical Center
Phone: 585-273-1141
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place