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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01144 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| RSRB052271 | Other Identifier | University of Rochester | |
| URCC14040 | Other Identifier | University of Rochester NCORP Research Base | |
| URCC-14040 | Other Identifier | DCP | |
| URCC-14040 | Other Identifier | CTEP | |
| R01CA181064 | U.S. NIH Grant/Contract | View source | |
| UG1CA189961 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized phase III trial compares yoga, survivorship health education program, and cognitive behavioral therapy in reducing sleep disturbance (insomnia) in cancer survivors. Insomnia can be described as excessive daytime napping, difficulty falling asleep, difficulty staying asleep, or waking up earlier than desired. Insomnia can increase fatigue, impair physical function, impair immune function, cause circadian rhythms (known as the biological clock) to be disrupted and decrease quality of life. Yoga may improve circadian rhythms, physical and immune function, and improve insomnia and sleep quality in cancer survivors. It is not yet known whether yoga is more effective at treating insomnia than a health education program or cognitive behavioral therapy program.
PRIMARY OBJECTIVES:
I. To determine if Yoga for Cancer Survivors (YOCAS) is effective for improving patient-reported insomnia (Insomnia Severity Index) compared to Cognitive Behavioral Therapy for Insomnia (CBT-I) and a health education control immediately post intervention.
SECONDARY OBJECTIVES:
I. To examine if YOCAS is effective for improving objective symptoms of insomnia (sleep latency, sleep efficiency, wake after sleep onset, sleep duration, and daytime napping via actigraphy) and global sleep quality impairment (Pittsburgh Sleep Quality Index) compared to CBT-I and a health education control.
II. To examine if YOCAS and CBT-I are effective for maintaining improvements in insomnia (Insomnia Severity Index) 3 and 6 months post intervention compared to a health education control.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: 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.
ARM II: 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.
ARM III: 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."
After completion of intervention, patients are followed up at 3 and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (behavioral intervention-yoga) | Experimental | 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. |
|
| Arm II (cognitive intervention-CBT-I) | Experimental | 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. |
|
| Arm III (educational intervention) | Active Comparator | 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." |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Intervention | Behavioral | Undergo yoga intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in the ISI Comparing YOCAS vs. CBT-I | 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. | Baseline up to post intervention (approximately 4 to 8 weeks) |
| Mean Change in the ISI Comparing YOCAS vs. Health Education | 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. | Baseline up to post intervention (approximately 4 to 8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. Health Education | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Mustian | University of Rochester NCORP Research Base | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hawaii MU NCORP | Honolulu | Hawaii | 96813 | United States | ||
| Heartland NCORP |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41170811 | Derived | Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2. | |
| 40903493 | Derived | Altman BJ, Lin PJ, Mattick LJ, Outland EH, Bautista J, Li CS, Gada U, Morris KM, Knudsen-Clark AM, Mwangi D, DeRollo RE, Kleckner AS, Kleckner IR, Gilmore NJ, Esparaz BT, Curtis A, Conlin A, Monaco G, Hughey JJ, Mustian KM. Blood Clock Correlation Distance (BloodCCD) as a novel marker to detect circadian rhythm disruption in cancer survivors with insomnia. BJC Rep. 2025 Sep 3;3(1):60. doi: 10.1038/s44276-025-00176-9. |
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6 participants were registered but not eligible.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 7, 2018 |
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| Cognitive Intervention | Other | Undergo CBT-I intervention |
|
| Educational Intervention | Other | Receive health education |
|
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Monitoring Device | Device | Correlative studies |
|
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Baseline up to post intervention (approximately 4 to 8 weeks) |
| Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. CBT-I. | 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. | Baseline up to post intervention (approximately 4 to 8 weeks) |
| Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. Health Education | 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. | Baseline up to post intervention (approximately 4 to 8 weeks) |
| Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. CBT-I | 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. | Baseline up to post intervention (approximately 4 to 8 weeks) |
| Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. Health Education | 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. | Baseline up to post intervention (approximately 4 to 8 weeks) |
| Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. CBT-I | 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. | Baseline up to post intervention (approximately 4 to 8 weeks) |
| Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. Health Education | 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. | Baseline up to post intervention (approximately 4 to 8 weeks) |
| Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. CBT-I | 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. | Baseline up to post intervention (approximately 4 to 8 weeks) |
| Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. Health Education | 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. | Baseline up to post intervention (approximately 4 to 8 weeks) |
| Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. CBT-I | 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. | Baseline up to post intervention (approximately 4 to 8 weeks) |
| Mean Change in the ISI Comparing YOCAS and Health Education (3 Month) | 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. | Baseline to 3 months |
| Mean Change in the ISI Comparing YOCAS and CBT-I (3 Month) | 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. | Baseline to 3 months |
| Mean Change in the ISI Comparing YOCAS and Health Education (6 Month) | 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. | Baseline to 6 months |
| Mean Change in the ISI Comparing YOCAS and CBT-I (6 Month) | 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. | Baseline to 6 months |
| Decatur |
| Illinois |
| 62526 |
| United States |
| Wichita NCORP | Wichita | Kansas | 67214 | United States |
| Gulf South MU-NCORP | New Orleans | Louisiana | 70112 | United States |
| Michigan Cancer Research Consortium NCORP | Ann Arbor | Michigan | 48106 | United States |
| Cancer Research Consortium of West Michigan | Grand Rapids | Michigan | 49503 | United States |
| Metro-Minnesota NCORP | Minneapolis | Minnesota | 55426 | United States |
| Nevada Cancer Research Foundation NCORP | Las Vegas | Nevada | 89106 | United States |
| University of Rochester NCORP Research Base | Rochester | New York | 14642 | United States |
| Southeast Clinical Oncology Research Consortium | Winston-Salem | North Carolina | 27104 | United States |
| Columbus NCORP | Columbus | Ohio | 43215 | United States |
| Dayton Clinical Oncology Program | Dayton | Ohio | 45420 | United States |
| Pacific Cancer Research Consortium Ncorp | Portland | Oregon | 97213 | United States |
| Greenville Health System NCORP | Greenville | South Carolina | 29605 | United States |
| Wisconsin NCORP | Marshfield | Wisconsin | 54449 | United States |
| Aurora NCORP | Milwaukee | Wisconsin | 53226 | United States |
| FG001 | 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 |
| FG002 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||
| ISI at Baseline | 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. | The difference between the number of participants analyzed and the overall number of baseline participants is due to participant withdrawal. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in the ISI Comparing YOCAS vs. CBT-I | 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline up to post intervention (approximately 4 to 8 weeks) |
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| Primary | Mean Change in the ISI Comparing YOCAS vs. Health Education | 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline up to post intervention (approximately 4 to 8 weeks) |
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| Secondary | Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. Health Education | 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline up to post intervention (approximately 4 to 8 weeks) |
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| Secondary | Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. CBT-I. | 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline up to post intervention (approximately 4 to 8 weeks) |
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| Secondary | Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. Health Education | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Baseline up to post intervention (approximately 4 to 8 weeks) |
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| Secondary | Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. CBT-I | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Baseline up to post intervention (approximately 4 to 8 weeks) |
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| Secondary | Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. Health Education | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Baseline up to post intervention (approximately 4 to 8 weeks) |
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| Secondary | Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. CBT-I | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Baseline up to post intervention (approximately 4 to 8 weeks) |
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| Secondary | Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. Health Education | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | percent of time | Baseline up to post intervention (approximately 4 to 8 weeks) |
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| Secondary | Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. CBT-I | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | percent of time | Baseline up to post intervention (approximately 4 to 8 weeks) |
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| Secondary | Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. Health Education | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Baseline up to post intervention (approximately 4 to 8 weeks) |
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| Secondary | Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. CBT-I | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Baseline up to post intervention (approximately 4 to 8 weeks) |
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| Secondary | Mean Change in the ISI Comparing YOCAS and Health Education (3 Month) | 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 3 months |
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| Secondary | Mean Change in the ISI Comparing YOCAS and CBT-I (3 Month) | 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 3 months |
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| Secondary | Mean Change in the ISI Comparing YOCAS and Health Education (6 Month) | 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 6 months |
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| Secondary | Mean Change in the ISI Comparing YOCAS and CBT-I (6 Month) | 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 6 months |
|
1 year and 9 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 251 | 3 | 251 | 0 | 251 |
| EG001 | 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 | 0 | 238 | 1 | 238 | 0 | 238 |
| EG002 | 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 | 0 | 251 | 1 | 251 | 0 | 251 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Nervous system disorders | Systematic Assessment |
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| Acute respiratory distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Confusion/brain met | Psychiatric disorders | Systematic Assessment |
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| Intracranial hemorrhage/brain met | Nervous system disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Intraparenchymal hemorrhage | Nervous system disorders | Systematic Assessment |
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| Hepatic Encephalopathy | Hepatobiliary disorders | Systematic Assessment |
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Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen Mustian, Study PI | University of Rochester Medical Center | 585-275-0557 | karen_mustian@urmc.rochester.edu |
| Feb 3, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D008991 | Monitoring, Physiologic |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
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Non-inferiority is established if the difference in mean change on the ISI between YOCAS©® and CBT-I is less than 1.15. Using ANCOVA to estimate differences in mean change between YOCAS©® and CBT-I, a correlation of 0.576 (from our prior study), and a sample of 168 subjects per group, we will have sufficient (80%) power to detect non-inferiority using a margin of 1.15 at p = 0.025.
| OG002 | 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 |
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| OG002 | 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 |
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| OG002 | 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 |
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| OG002 | 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 |
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| OG002 | 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 |
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| OG002 | 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 |
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| OG002 | 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 |
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| OG002 | 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 |
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| OG002 | 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 |
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| OG002 | 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 |
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| OG002 | 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 |
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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
| OG002 | 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 |
|
|
|
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
| OG002 | 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 |
|
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| OG002 | 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 |
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| OG002 | 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 |
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