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Trial Title:
FAMILY Sleep Program
NCT ID:
NCT06571305
Condition:
Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Brief Behavioral Treatment for Insomnia (BBTI)
Description:
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.
Arm group label:
Phase 2 BBTI Intervention Group
Intervention type:
Behavioral
Intervention name:
My Sleep Our Sleep (MSOS)
Description:
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.
Arm group label:
Phase 2 MSOS Intervention Group
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- The eligibility criteria for patients are
- newly diagnosed with stage I to IV of a solid tumor
- diagnosis in the past three 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
University of Miami
Address:
City:
Coral Gables
Zip:
33146
Country:
United States
Status:
Recruiting
Contact:
Last name:
Youngmee Kim, PhD
Phone:
305-284-5439
Email:
ykim@miami.edu
Investigator:
Last name:
Youngmee Kim, PhD
Email:
Principal Investigator
Start date:
August 1, 2024
Completion date:
October 1, 2026
Lead sponsor:
Agency:
University of Miami
Agency class:
Other
Collaborator:
Agency:
Community Foundation for Brevard
Agency class:
Other
Source:
University of Miami
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06571305
