Clinical trial · Interventional
FAMILY Sleep Program
NCT06571305CI-TRIAL-00122068recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brief Behavioral Treatment for Insomnia (BBTI) | Behavioral | — | UNRESOLVED |
| My Sleep Our Sleep (MSOS) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase 2 BBTI Intervention Group
- description
- 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.
- interventionNames
- Behavioral: Brief Behavioral Treatment for Insomnia (BBTI)
- type
- EXPERIMENTAL
- label
- Phase 2 MSOS Intervention Group
- description
- 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.
- interventionNames
- Behavioral: My Sleep Our Sleep (MSOS)
Primary outcomes (2)
- measure
- Proportion of participants adapting to BBTI
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The eligibility criteria for patients are * newly diagnosed with stage I to IV of a solid tumor * diagnosis in the past seven years at the time of enrollment * having a consistent sleep partner. * The eligibility criterion for caregivers is * a sleep partner of the patient. * Additional eligibility criteria for both patients and caregivers are * Pittsburgh Sleep Quality Index (PSQI) ≥ 5, * willing to change sub-optimal sleep habits, * 18 years or older, * able to speak/listen English at the 8th grade level for intervention sessions, * able to read English or Spanish at the 8th grade for self-reported questionnaires, reside in Brevard County, Florida (FL), * only for participants of Aim 2, \> 4 weeks after surgery, if any, prior to enrollment, and no surgery planned in the next 5 weeks during the study period because surgery affects sleep. Exclusion Criteria: * Exclusion criteria for both patients and caregivers are: * having had a diagnosis of major depressive disorder, psychosis, or bipolar disorder that is not currently treated; * active suicidality, or substance or alcohol dependency in the past year; * currently have narcolepsy, restless leg syndrome, or untreated sleep apnea that is screened using the Sleep Health Screen; * both patients and caregivers have an extreme chronotype, or do shift work to have no overlap in sleep schedule between them; and * plan trans-meridian travel during the period of data collection blocks; and * having hearing or visual impairment, dementia, or cognitive dysfunction. * Adults unable to consent, individuals who are not yet adults, pregnant women, or prisoners will be excluded.
References
Publications (0)
Data not yet available
No reference posted for this study.