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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-06704 | Registry Identifier | NCI Clinical Trials Reporting Program (NCI CTRP) |
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| Name | Class |
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| Community Foundation for Brevard | UNKNOWN |
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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 partners. Participants (patient-sleep-partner caregivers dyads as a unit) participate in the study together.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 2 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 4 weeks. |
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| Phase 2 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 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 spent 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants adapting to BBTI | The proportion of participants (patient--sleep-partner caregiver dyads) who adapt to Brief Behavioral Treatment for Insomnia (BBTI). | Up to 4 weeks |
| Change in Sleep Disturbance Symptoms Measured by Pittsburgh Sleep Quality Index (PSQI) | The proportion of participants (patient-sleep-partner caregiver dyads) experiencing a change in sleep disturbance symptoms will be compared and reported for both intervention groups, BBTI and MSOS, as measured by scores on the Pittsburgh Sleep Quality Index (PSQI) health-related quality of life HRQOL) questionnaire. The PSQI is a self-reported, 19-item questionnaire which assesses sleep quality and disturbances at baseline and over a four week period. 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. The PSQI global score has a possible range of 0-21 points. A total score of 5 or above indicates overall poor sleep quality. | Baseline, Up to 4 weeks |
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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:
Exclusion criteria for both patients and caregivers are:
Adults unable to consent, individuals who are not yet adults, pregnant women, or prisoners will be excluded.
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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 |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| My Sleep Our Sleep (MSOS) | 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. |
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