Trial Outcomes & Findings for Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy in Reducing Insomnia in Cancer Survivors (NCT NCT02613364)
NCT ID: NCT02613364
Last Updated: 2024-05-01
Results Overview
The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. Means and 95% confidence intervals for YOCAS and CBT-I will be calculated and plotted and examined in comparison with the a priori specified non-inferiority margin of 1.15.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
746 participants
Primary outcome timeframe
Baseline up to post intervention (approximately 4 to 8 weeks)
Results posted on
2024-05-01
Participant Flow
6 participants were registered but not eligible.
Participant milestones
| Measure |
Arm I (Behavioral Intervention-yoga)
Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.
Behavioral Intervention: Undergo yoga intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Cognitive Intervention-CBT-I)
Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.
Cognitive Intervention: Undergo CBT-I intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Educational Intervention)
Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families."
Educational Intervention: Receive health education
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Overall Study
STARTED
|
251
|
238
|
251
|
|
Overall Study
COMPLETED
|
185
|
148
|
175
|
|
Overall Study
NOT COMPLETED
|
66
|
90
|
76
|
Reasons for withdrawal
| Measure |
Arm I (Behavioral Intervention-yoga)
Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.
Behavioral Intervention: Undergo yoga intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Cognitive Intervention-CBT-I)
Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.
Cognitive Intervention: Undergo CBT-I intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Educational Intervention)
Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families."
Educational Intervention: Receive health education
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Overall Study
Other
|
19
|
29
|
17
|
|
Overall Study
Too time consuming
|
21
|
26
|
26
|
|
Overall Study
Withdrawal by Subject
|
13
|
18
|
17
|
|
Overall Study
Medical
|
12
|
13
|
9
|
|
Overall Study
Disliked Study Procedure
|
1
|
1
|
4
|
|
Overall Study
Disliked Intervention
|
0
|
3
|
3
|
Baseline Characteristics
The difference between the number of participants analyzed and the overall number of baseline participants is due to participant withdrawal.
Baseline characteristics by cohort
| Measure |
Arm I (Behavioral Intervention-yoga)
n=251 Participants
Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.
Behavioral Intervention: Undergo yoga intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Cognitive Intervention-CBT-I)
n=238 Participants
Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.
Cognitive Intervention: Undergo CBT-I intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Educational Intervention)
n=251 Participants
Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families."
Educational Intervention: Receive health education
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Total
n=740 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55 years
n=251 Participants
|
56 years
n=238 Participants
|
57 years
n=251 Participants
|
56 years
n=740 Participants
|
|
Sex: Female, Male
Female
|
234 Participants
n=251 Participants
|
216 Participants
n=238 Participants
|
236 Participants
n=251 Participants
|
686 Participants
n=740 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=251 Participants
|
22 Participants
n=238 Participants
|
15 Participants
n=251 Participants
|
54 Participants
n=740 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=251 Participants
|
2 Participants
n=238 Participants
|
2 Participants
n=251 Participants
|
4 Participants
n=740 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=251 Participants
|
3 Participants
n=238 Participants
|
3 Participants
n=251 Participants
|
11 Participants
n=740 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=251 Participants
|
0 Participants
n=238 Participants
|
0 Participants
n=251 Participants
|
2 Participants
n=740 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=251 Participants
|
26 Participants
n=238 Participants
|
28 Participants
n=251 Participants
|
83 Participants
n=740 Participants
|
|
Race (NIH/OMB)
White
|
213 Participants
n=251 Participants
|
207 Participants
n=238 Participants
|
214 Participants
n=251 Participants
|
634 Participants
n=740 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=251 Participants
|
0 Participants
n=238 Participants
|
0 Participants
n=251 Participants
|
0 Participants
n=740 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=251 Participants
|
0 Participants
n=238 Participants
|
4 Participants
n=251 Participants
|
6 Participants
n=740 Participants
|
|
Region of Enrollment
United States
|
251 participants
n=251 Participants
|
238 participants
n=238 Participants
|
251 participants
n=251 Participants
|
740 participants
n=740 Participants
|
|
ISI at Baseline
|
15.41 units on a scale
STANDARD_DEVIATION 4.34 • n=216 Participants • The difference between the number of participants analyzed and the overall number of baseline participants is due to participant withdrawal.
|
15.57 units on a scale
STANDARD_DEVIATION 4.35 • n=198 Participants • The difference between the number of participants analyzed and the overall number of baseline participants is due to participant withdrawal.
|
15.39 units on a scale
STANDARD_DEVIATION 4.39 • n=205 Participants • The difference between the number of participants analyzed and the overall number of baseline participants is due to participant withdrawal.
|
15.45 units on a scale
STANDARD_DEVIATION 4.35 • n=619 Participants • The difference between the number of participants analyzed and the overall number of baseline participants is due to participant withdrawal.
|
PRIMARY outcome
Timeframe: Baseline up to post intervention (approximately 4 to 8 weeks)Population: The overall number of participants analyzed is higher than the number of participants who completed the study because the timeframe for this outcome measure was from baseline up to post-intervention. Some participants withdrew after the post-intervention assessment.
The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. Means and 95% confidence intervals for YOCAS and CBT-I will be calculated and plotted and examined in comparison with the a priori specified non-inferiority margin of 1.15.
Outcome measures
| Measure |
Arm I (Behavioral Intervention-yoga)
n=202 Participants
Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.
Behavioral Intervention: Undergo yoga intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Cognitive Intervention-CBT-I)
n=163 Participants
Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.
Cognitive Intervention: Undergo CBT-I intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Educational Intervention)
n=185 Participants
Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families."
Educational Intervention: Receive health education
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Mean Change in the ISI Comparing YOCAS vs. CBT-I
|
-3.61 units on a scale
Interval -4.19 to -3.03
|
-7.22 units on a scale
Interval -7.95 to -6.49
|
-2.19 units on a scale
Interval -2.84 to -1.55
|
PRIMARY outcome
Timeframe: Baseline up to post intervention (approximately 4 to 8 weeks)Population: The overall number of participants analyzed is higher than the number of participants who completed the study because the timeframe for this outcome measure was from baseline up to post-intervention. Some participants withdrew after the post-intervention assessment.
The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.
Outcome measures
| Measure |
Arm I (Behavioral Intervention-yoga)
n=202 Participants
Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.
Behavioral Intervention: Undergo yoga intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Cognitive Intervention-CBT-I)
n=163 Participants
Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.
Cognitive Intervention: Undergo CBT-I intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Educational Intervention)
n=185 Participants
Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families."
Educational Intervention: Receive health education
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Mean Change in the ISI Comparing YOCAS vs. Health Education
|
-3.61 units on a scale
Interval -4.19 to -3.03
|
-7.22 units on a scale
Interval -7.95 to -6.49
|
-2.19 units on a scale
Interval -2.84 to -1.55
|
SECONDARY outcome
Timeframe: Baseline up to post intervention (approximately 4 to 8 weeks)Population: The overall number of participants analyzed is higher than the number of participants who completed the study because the timeframe for this outcome measure was from baseline up to post-intervention. Some participants withdrew after the post-intervention assessment.
The PSQI measures sleep quality with a total score ranging from 0-21 with higher scores indicating worse sleep quality. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.
Outcome measures
| Measure |
Arm I (Behavioral Intervention-yoga)
n=202 Participants
Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.
Behavioral Intervention: Undergo yoga intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Cognitive Intervention-CBT-I)
n=163 Participants
Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.
Cognitive Intervention: Undergo CBT-I intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Educational Intervention)
n=186 Participants
Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families."
Educational Intervention: Receive health education
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. Health Education
|
-1.59 units on a scale
Interval -1.99 to -1.18
|
-3.82 units on a scale
Interval -4.3 to -3.33
|
-1.11 units on a scale
Interval -1.55 to -0.68
|
SECONDARY outcome
Timeframe: Baseline up to post intervention (approximately 4 to 8 weeks)Population: The overall number of participants analyzed is higher than the number of participants who completed the study because the timeframe for this outcome measure was from baseline up to post-intervention. Some participants withdrew after the post-intervention assessment.
The PSQI measures sleep quality with a total score ranging from 0-21 with higher scores indicating worse sleep quality. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I.
Outcome measures
| Measure |
Arm I (Behavioral Intervention-yoga)
n=202 Participants
Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.
Behavioral Intervention: Undergo yoga intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Cognitive Intervention-CBT-I)
n=163 Participants
Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.
Cognitive Intervention: Undergo CBT-I intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Educational Intervention)
n=186 Participants
Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families."
Educational Intervention: Receive health education
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. CBT-I.
|
-1.59 units on a scale
Interval -1.99 to -1.18
|
-3.82 units on a scale
Interval -4.3 to -3.33
|
-1.11 units on a scale
Interval -1.55 to -0.68
|
SECONDARY outcome
Timeframe: Baseline up to post intervention (approximately 4 to 8 weeks)Population: The overall number of participants analyzed is lower than the number of participants who completed the study. This difference is due to the actigraphy device malfunction or battery issue and participant non-compliance.
Actigraphy will measure the number of minutes of actual sleep. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.
Outcome measures
| Measure |
Arm I (Behavioral Intervention-yoga)
n=150 Participants
Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.
Behavioral Intervention: Undergo yoga intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Cognitive Intervention-CBT-I)
n=135 Participants
Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.
Cognitive Intervention: Undergo CBT-I intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Educational Intervention)
n=144 Participants
Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families."
Educational Intervention: Receive health education
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. Health Education
|
395.99 minutes
Interval 383.49 to 408.5
|
380.06 minutes
Interval 366.93 to 393.18
|
376.27 minutes
Interval 363.06 to 389.48
|
SECONDARY outcome
Timeframe: Baseline up to post intervention (approximately 4 to 8 weeks)Population: The overall number of participants analyzed is lower than the number of participants who completed the study. This difference is due to the actigraphy device malfunction or battery issue and participant non-compliance.
Actigraphy will measure the number of minutes of actual sleep. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I.
Outcome measures
| Measure |
Arm I (Behavioral Intervention-yoga)
n=150 Participants
Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.
Behavioral Intervention: Undergo yoga intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Cognitive Intervention-CBT-I)
n=135 Participants
Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.
Cognitive Intervention: Undergo CBT-I intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Educational Intervention)
n=144 Participants
Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families."
Educational Intervention: Receive health education
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. CBT-I
|
395.99 minutes
Interval 383.49 to 408.5
|
380.06 minutes
Interval 366.93 to 393.18
|
376.27 minutes
Interval 363.06 to 389.48
|
SECONDARY outcome
Timeframe: Baseline up to post intervention (approximately 4 to 8 weeks)Population: The overall number of participants analyzed is lower than the number of participants who completed the study. This difference is due to the actigraphy device malfunction or battery issue and participant non-compliance.
Actigraphy will measure total minutes of wake time after sleep onset. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education. The transformation of the log base 10 of the original measurement was used for the analysis.
Outcome measures
| Measure |
Arm I (Behavioral Intervention-yoga)
n=150 Participants
Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.
Behavioral Intervention: Undergo yoga intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Cognitive Intervention-CBT-I)
n=135 Participants
Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.
Cognitive Intervention: Undergo CBT-I intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Educational Intervention)
n=144 Participants
Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families."
Educational Intervention: Receive health education
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. Health Education
|
1.85 minutes
Interval 1.81 to 1.89
|
1.81 minutes
Interval 1.76 to 1.85
|
1.86 minutes
Interval 1.81 to 1.9
|
SECONDARY outcome
Timeframe: Baseline up to post intervention (approximately 4 to 8 weeks)Population: The overall number of participants analyzed is lower than the number of participants who completed the study. This difference is due to the actigraphy device malfunction or battery issue and participant non-compliance.
Actigraphy will measure total minutes of wake time after sleep onset. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I. The transformation of log base 10 of the original measurement was used for the analysis.
Outcome measures
| Measure |
Arm I (Behavioral Intervention-yoga)
n=150 Participants
Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.
Behavioral Intervention: Undergo yoga intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Cognitive Intervention-CBT-I)
n=135 Participants
Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.
Cognitive Intervention: Undergo CBT-I intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Educational Intervention)
n=144 Participants
Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families."
Educational Intervention: Receive health education
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. CBT-I
|
1.85 minutes
Interval 1.81 to 1.89
|
1.81 minutes
Interval 1.76 to 1.85
|
1.86 minutes
Interval 1.81 to 1.9
|
SECONDARY outcome
Timeframe: Baseline up to post intervention (approximately 4 to 8 weeks)Population: The overall number of participants analyzed is lower than the number of participants who completed the study. This difference is due to the actigraphy device malfunction or battery issue and participant non-compliance.
Actigraphy will measure the percent of time actually slept compared to intended time sleeping. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.
Outcome measures
| Measure |
Arm I (Behavioral Intervention-yoga)
n=150 Participants
Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.
Behavioral Intervention: Undergo yoga intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Cognitive Intervention-CBT-I)
n=135 Participants
Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.
Cognitive Intervention: Undergo CBT-I intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Educational Intervention)
n=144 Participants
Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families."
Educational Intervention: Receive health education
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. Health Education
|
81.65 percent of time
Interval 79.57 to 83.73
|
82.42 percent of time
Interval 80.24 to 84.6
|
79.38 percent of time
Interval 77.19 to 81.58
|
SECONDARY outcome
Timeframe: Baseline up to post intervention (approximately 4 to 8 weeks)Population: The overall number of participants analyzed is lower than the number of participants who completed the study. This difference is due to the actigraphy device malfunction or battery issue and participant non-compliance.
Actigraphy will measure the percent of time actually slept compared to intended time sleeping. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I.
Outcome measures
| Measure |
Arm I (Behavioral Intervention-yoga)
n=150 Participants
Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.
Behavioral Intervention: Undergo yoga intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Cognitive Intervention-CBT-I)
n=135 Participants
Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.
Cognitive Intervention: Undergo CBT-I intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Educational Intervention)
n=144 Participants
Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families."
Educational Intervention: Receive health education
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. CBT-I
|
81.65 percent of time
Interval 79.57 to 83.73
|
82.42 percent of time
Interval 80.24 to 84.6
|
79.38 percent of time
Interval 77.19 to 81.58
|
SECONDARY outcome
Timeframe: Baseline up to post intervention (approximately 4 to 8 weeks)Population: The overall number of participants analyzed is lower than the number of participants who completed the study. This difference is due to the actigraphy device malfunction or battery issue and participant non-compliance.
Actigraphy will measure the minutes it takes for the participant to fall asleep. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education. The transformation of log base 10 of the (measurement + 1) was used in the analysis.
Outcome measures
| Measure |
Arm I (Behavioral Intervention-yoga)
n=150 Participants
Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.
Behavioral Intervention: Undergo yoga intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Cognitive Intervention-CBT-I)
n=135 Participants
Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.
Cognitive Intervention: Undergo CBT-I intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Educational Intervention)
n=144 Participants
Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families."
Educational Intervention: Receive health education
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. Health Education
|
0.76 minutes
Interval 0.69 to 0.83
|
0.74 minutes
Interval 0.67 to 0.82
|
0.80 minutes
Interval 0.73 to 0.87
|
SECONDARY outcome
Timeframe: Baseline up to post intervention (approximately 4 to 8 weeks)Population: The overall number of participants analyzed is lower than the number of participants who completed the study. This difference is due to the actigraphy device malfunction or battery issue and participant non-compliance.
Actigraphy will measure the minutes it takes for the participant to fall asleep. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I. The transformation of the log base 10 of the (measure + 1) was used in the analysis.
Outcome measures
| Measure |
Arm I (Behavioral Intervention-yoga)
n=150 Participants
Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.
Behavioral Intervention: Undergo yoga intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Cognitive Intervention-CBT-I)
n=135 Participants
Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.
Cognitive Intervention: Undergo CBT-I intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Educational Intervention)
n=144 Participants
Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families."
Educational Intervention: Receive health education
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. CBT-I
|
0.76 minutes
Interval 0.69 to 0.83
|
0.74 minutes
Interval 0.67 to 0.82
|
0.80 minutes
Interval 0.73 to 0.87
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsPopulation: The overall number of participants analyzed in arms I \& II is higher than the number of participants who completed the study. This difference is due to some participants withdrew after this outcome measure was collected. The overall number of participants analyzed in arm III is lower than the number of participants who completed the study. This difference is due to participant non-compliance.
The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.
Outcome measures
| Measure |
Arm I (Behavioral Intervention-yoga)
n=189 Participants
Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.
Behavioral Intervention: Undergo yoga intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Cognitive Intervention-CBT-I)
n=153 Participants
Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.
Cognitive Intervention: Undergo CBT-I intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Educational Intervention)
n=173 Participants
Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families."
Educational Intervention: Receive health education
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Mean Change in the ISI Comparing YOCAS and Health Education (3 Month)
|
-5.02 units on a scale
Interval -5.72 to -4.28
|
-7.59 units on a scale
Interval -8.37 to -6.81
|
-3.56 units on a scale
Interval -4.31 to -2.82
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsPopulation: The overall number of participants analyzed in arms I \& II is higher than the number of participants who completed the study. This difference is due to some participants withdrew after this outcome measure was collected. The overall number of participants analyzed in arm III is lower than the number of participants who completed the study. This difference is due to participant non-compliance.
The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I.
Outcome measures
| Measure |
Arm I (Behavioral Intervention-yoga)
n=189 Participants
Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.
Behavioral Intervention: Undergo yoga intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Cognitive Intervention-CBT-I)
n=153 Participants
Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.
Cognitive Intervention: Undergo CBT-I intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Educational Intervention)
n=173 Participants
Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families."
Educational Intervention: Receive health education
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Mean Change in the ISI Comparing YOCAS and CBT-I (3 Month)
|
-5.02 units on a scale
Interval -5.72 to -4.28
|
-7.59 units on a scale
Interval -8.37 to -6.81
|
-3.56 units on a scale
Interval -4.31 to -2.82
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: The overall number of participants analyzed is lower than the number of participants who completed the study. This difference is due to participant non-compliance.
The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.
Outcome measures
| Measure |
Arm I (Behavioral Intervention-yoga)
n=182 Participants
Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.
Behavioral Intervention: Undergo yoga intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Cognitive Intervention-CBT-I)
n=144 Participants
Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.
Cognitive Intervention: Undergo CBT-I intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Educational Intervention)
n=171 Participants
Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families."
Educational Intervention: Receive health education
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Mean Change in the ISI Comparing YOCAS and Health Education (6 Month)
|
-5.29 units on a scale
Interval -6.0 to -4.57
|
-7.93 units on a scale
Interval -8.71 to -7.15
|
-3.91 units on a scale
Interval -4.75 to -3.07
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: The overall number of participants analyzed is lower than the number of participants who completed the study. This difference is due to participant non-compliance.
The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I.
Outcome measures
| Measure |
Arm I (Behavioral Intervention-yoga)
n=182 Participants
Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.
Behavioral Intervention: Undergo yoga intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Cognitive Intervention-CBT-I)
n=144 Participants
Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.
Cognitive Intervention: Undergo CBT-I intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Educational Intervention)
n=171 Participants
Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families."
Educational Intervention: Receive health education
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Mean Change in the ISI Comparing YOCAS and CBT-I (6 Month)
|
-5.29 units on a scale
Interval -6.0 to -4.57
|
-7.93 units on a scale
Interval -8.71 to -7.15
|
-3.91 units on a scale
Interval -4.75 to -3.07
|
Adverse Events
Arm I (Behavioral Intervention-yoga)
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm II (Cognitive Intervention-CBT-I)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm III (Educational Intervention)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Behavioral Intervention-yoga)
n=251 participants at risk
Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.
Behavioral Intervention: Undergo yoga intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Cognitive Intervention-CBT-I)
n=238 participants at risk
Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.
Cognitive Intervention: Undergo CBT-I intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Educational Intervention)
n=251 participants at risk
Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families."
Educational Intervention: Receive health education
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Nervous system disorders
Stroke
|
0.40%
1/251 • Number of events 1 • 1 year and 9 months
|
0.00%
0/238 • 1 year and 9 months
|
0.00%
0/251 • 1 year and 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress
|
0.00%
0/251 • 1 year and 9 months
|
0.00%
0/238 • 1 year and 9 months
|
0.40%
1/251 • Number of events 2 • 1 year and 9 months
|
|
Psychiatric disorders
Confusion/brain met
|
0.40%
1/251 • Number of events 1 • 1 year and 9 months
|
0.00%
0/238 • 1 year and 9 months
|
0.00%
0/251 • 1 year and 9 months
|
|
Nervous system disorders
Intracranial hemorrhage/brain met
|
0.40%
1/251 • Number of events 2 • 1 year and 9 months
|
0.00%
0/238 • 1 year and 9 months
|
0.00%
0/251 • 1 year and 9 months
|
|
Psychiatric disorders
Depression
|
0.40%
1/251 • Number of events 1 • 1 year and 9 months
|
0.00%
0/238 • 1 year and 9 months
|
0.00%
0/251 • 1 year and 9 months
|
|
Nervous system disorders
Intraparenchymal hemorrhage
|
0.00%
0/251 • 1 year and 9 months
|
0.42%
1/238 • Number of events 1 • 1 year and 9 months
|
0.00%
0/251 • 1 year and 9 months
|
|
Hepatobiliary disorders
Hepatic Encephalopathy
|
0.00%
0/251 • 1 year and 9 months
|
0.42%
1/238 • Number of events 1 • 1 year and 9 months
|
0.00%
0/251 • 1 year and 9 months
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Karen Mustian, Study PI
University of Rochester Medical Center
Phone: 585-275-0557
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place