Clinical trial · Interventional
Dyadic Sleep Study
NCT06569693CI-TRIAL-00105055recruitingN/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 caregiver partners.
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 |
|---|---|---|---|
| Gastrointestinal Cancer | Malignant Digestive System 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) Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 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 13 weeks.
- interventionNames
- Behavioral: My Sleep Our Sleep (MSOS) Program
- type
- EXPERIMENTAL
- label
- 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 13 weeks.
- interventionNames
- Behavioral: Brief Behavioral Treatment for Insomnia (BBTI)
Primary outcomes (1)
- measure
- Change in sleep disturbance symptoms as measured by scores on the Pittsburgh Sleep Quality Index (PSQI)
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 GI cancer (anus, colon, esophagus, gallbladder, large and small intestine, liver, pancreas, rectum, stomach, other biliary or digestive organs) * diagnosis in the past 72 months at the time of enrollment * having a consistent sleep partner. * The eligibility criterion for caregivers is: * a sleep partner of the patient or partner who wish to resume sleeping together with 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, * \> 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 (1)
- DERIVEDKim 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. PMID 40514758