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| ID | Type | Description | Link |
|---|---|---|---|
| R03CA201459-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This research study is evaluating the effectiveness of a 3-session behavioral intervention for insomnia in cancer survivors. This is a behavioral intervention study, and no medications are involved.
This study is being done to test the usefulness of a 3-session cognitive-behavioral intervention for improving insomnia in cancer survivors. In this study, the investigators are testing whether this 3-session intervention (Cognitive Behavior Therapy for Insomnia in Cancer Survivors: CBTI-CS) will improve insomnia in cancer survivors whose continue to have insomnia symptoms after receiving sleep hygiene education.
In addition to the participants who will be offered sleep hygiene education and the 3-session CBTI-CS,10 additional participants will be recruited to participate in a pilot evaluation of the CBTI-CS intervention delivered via telehealth. This will be a pilot aspect of the study and data from these participants will be for descriptive purposes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (Sleep Hygiene & CBTI-CS) | Experimental | Participants receive a single educational session describing principles of Sleep Hygiene for Cancer Survivors. Those who continue to have significant symptoms of insomnia then receive 3 groups CBTI-CS sessions |
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| Arm B (Telehealth Pilot of CBTI-CS) | Other | Descriptive data collected on 10 participants (non-randomized) receiving CBTI-CS via Telehealth. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBTI-CS | Behavioral | CBTI-CS is a multi-modal intervention designed to address both cognitive and behavioral factors that perpetuate insomnia. Cognitive factors are addressed via cognitive restructuring and psychoeducation. Behavioral factors are addressed by structured sleep restriction, stimulus control and sleep hygiene techniques. Cancer treatment late-effects affecting sleep are addressed as potential contributors to these cognitive and behavioral factors, and as symptoms that may benefit from referral for medical evaluation/management. Participants are instructed in these cognitive-behavioral strategies as a group, but using analysis of personal sleep-log data, symptom self-reports and targeted workbook exercises, they are helped to tailor the intervention to address their specific needs. |
| Measure | Description | Time Frame |
|---|---|---|
| The Insomnia Severity Index (ISI) | The ISI is a 7-item self-report questionnaire assessing severity, and impact of insomnia symptoms. | Change from Baseline to 4-weeks post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Profile of Mood States - Short Form (POMS-SF) | A 35-item measure which assesses mood states along several dimensions including Total Mood Disturbance. | Change from Baseline to 4 & 8 weeks post-intervention |
| The Insomnia Severity Index (ISI) |
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Inclusion Criteria:
-≥ 18 years of age
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Recklitis, PhD, MPH | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26872123 | Background | Zhou ES, Partridge AH, Recklitis CJ. A pilot trial of brief group cognitive-behavioral treatment for insomnia in an adult cancer survivorship program. Psychooncology. 2017 Jun;26(6):843-848. doi: 10.1002/pon.4096. Epub 2016 Feb 12. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Sleep Hygiene | Behavioral | Education on health behaviors, sleep habits and environmental practices intended to promote good quality sleep. Recommendations target exercise and natural light exposure,use of stimulants and alcohol, daytime napping, timing of meals, creating a comfortable non-stimulating sleep space, and creating sleep rituals. |
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| CBTI-CS via Telehealth | Behavioral | The CBTI-CS intervention, a multi-modal intervention designed to address both cognitive and behavioral factors that perpetuate insomnia, will be administered via live video. conferencing. Participants will have a single in-person training session and subsequent CBTI-CS group sessions will be conducted by live video conference. |
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The ISI is a 7-item self-report questionnaire assessing severity, and impact of insomnia symptoms.
| Change from Baseline to 8 weeks post-intervention |
| D001523 |
| Mental Disorders |