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| ID | Type | Description | Link |
|---|---|---|---|
| R21NR021083 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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The purpose of this study is to learn about sleep behaviors and test different ways to help patients with cancer and caregiver partners.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSOS Intervention Group | Experimental | Participants (patient-sleep-partner caregiver dyads) in this group will receive the My Sleep Our Sleep (MSOS) intervention. Total participation is up to 13 weeks. |
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| BBTI Intervention Group | Experimental | Participants (patient-sleep-partner caregiver dyads) in this group will receive the Brief Behavioral Treatment for Insomnia (BBTI). Total participation is up to 13 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| My Sleep Our Sleep (MSOS) Program | Behavioral | MSOS is a sleep intervention developed by the investigator aimed at improving sleep health for patient-sleep-partner caregiver dyads using behavioral education in sleep behaviors, sleep cognition and sleep in relationship. MSOS will be delivered over four weeks, in weekly one-hour sessions, one session per week. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in sleep disturbance symptoms as measured by scores on the Pittsburgh Sleep Quality Index (PSQI) | Change in sleep disturbance symptoms (patient-sleep-partner caregiver dyads) among participants will be compared and reported for both intervention groups, BBTI and MSOS, as measured by scores on the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-reported, 19-item questionnaire health-related quality of life (HRQOL) questionnaire which assesses sleep quality and disturbances at baseline, week 5 and week 13. Questions generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. A decrease of ≥ 5 points on the PSQI) will be considered as clinical improvement of symptoms. | Baseline, Up to 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in insomnia symptoms as measured by scores on the Insomnia Severity Index (ISI) | Change in insomnia symptoms among participants (patient-sleep-partner caregiver dyads) will be compared and reported for both intervention groups, BBTI and MSOS, as measured by scores on the 7-item Insomnia Severity Index (ISI). The ISI is a self-reported, health-related quality of life (HRQOL) questionnaire used to assess insomnia symptoms at baseline, week 5 and week 13. The dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, notice ability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item, ranging from 0 to 4 (e.g., 0 = no problem; 4 = very severe problem). The total score ranges from 0 to 28, the lower total score indicates a lower level of insomnia. Greater than a 6-point decrease on the ISI is considered substantial reduction in insomnia symptoms. |
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Inclusion Criteria:
The eligibility criteria for patients are:
The eligibility criterion for caregivers is:
Additional eligibility criteria for both patients and caregivers are:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Youngmee Kim, PhD | Contact | 305-284-5439 | ykim@miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Youngmee Kim, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Coral Gables | Florida | 33146 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40514758 | Derived | Kim Y, Tsai TC, Steel JL, Ramos AR, Laurenceau JP, Troxel WM. Protocol of testing the feasibility and acceptability of two brief dyadic sleep interventions for adults with cancer and their bedpartner caregivers. Pilot Feasibility Stud. 2025 Jun 14;11(1):82. doi: 10.1186/s40814-025-01671-z. |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| Brief Behavioral Treatment for Insomnia (BBTI) | Behavioral | BBTI is brief patient-focused intervention for patient-sleep-partner caregiver dyads, aimed at altering participants' sleep behaviors to improve sleep. BBTI utilizes behavioral education in sleep restriction and stimulus control. For sleep restriction, participants will be instructed to limit the time they spend in bed, which serves to increase sleep efficiency. For stimulus control, participants will be instructed to go to bed only when feeling sleepy and reserve the bed for sleep and intimacy. BBTI will be delivered over four weeks, in weekly one-hour sessions, one session per week. |
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| Baseline, Up to 13 weeks |
| University of Pittsburgh | Active, not recruiting | Pittsburgh | Pennsylvania | 15260 | United States |
| D005767 |
| Gastrointestinal Diseases |