This clinical trial evaluates sleep behaviors and tests different ways to help patients with stage I-IV gastrointestinal (GI) cancer and their partners. Sleep disturbance (insomnia) is highly prevalent in adult patients with cancer across all cancer sites/types and their caregivers. Sleep disturbance is defined as difficulty falling asleep, difficulty staying asleep, and frequent and prolonged nighttime awakenings which is common among cancer patients. Family cancer caregivers have self-reported or objectively assessed sleep disturbance. Brief Behavioral Treatment for Insomnia (BBTI) is a brief patient-focused intervention, addressing the sleep disturbance issues with dissemination of the cognitive behavioral therapy for insomnia (CBT-I), which is a gold standard psychobehavioral intervention. My Sleep Our Sleep (MSOS) is a sleep intervention for adult patients with cancer and their sleep-partner caregivers. MSOS may improve sleep and quality of life in patients with stage I-IV GI cancer and their caregivers.
Additional locations may be listed on ClinicalTrials.gov for NCT06569693.
Locations matching your search criteria
United States
Florida
Aventura
UM Sylvester Comprehensive Cancer Center at AventuraStatus: Active
Contact: Youngmee Kim
Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral GablesStatus: Active
Contact: Youngmee Kim
Coral Springs
UM Sylvester Comprehensive Cancer Center at Coral SpringsStatus: Active
Contact: Youngmee Kim
Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield BeachStatus: Active
Contact: Youngmee Kim
Hollywood
UM Sylvester Comprehensive Cancer Center at HollywoodStatus: Active
Contact: Youngmee Kim
Miami
University of Miami Miller School of Medicine-Sylvester Cancer CenterStatus: Active
Contact: Youngmee Kim
Phone: 305-284-5439
UM Sylvester Comprehensive Cancer Center at KendallStatus: Active
Contact: Youngmee Kim
Plantation
UM Sylvester Comprehensive Cancer Center at PlantationStatus: Active
Contact: Youngmee Kim
PRIMARY OBJECTIVES:
I. To establish whether MSOS (38 dyads) produces effects that are similar to BBTI (38 dyads) in reducing insomnia symptoms (assessed by the Pittsburgh Sleep Quality Index: primary outcome) in patients of colorectal cancer and their sleep-partner caregivers.
II. To test the preliminary efficacy of the MSOS that is similar to BBTI in reducing other sleep disturbance indices (secondary outcomes) and improving health-related quality of life (HRQOL) (tertiary outcomes).
III. To explore whether dyads in the MSOS report greater increases of self-disclosure and intimacy than those in the BBTI at T2 and T3.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants participate in the MSOS program virtually consisting of psychoeducation and cognitive-behavioral recommendations to improve sleep-related behaviors, cognition and mood, and close relationships weekly over 60 minutes for 4 weeks.
ARM II: Participants participate in the standard BBTI program virtually consisting of psychoeducation and cognitive-behavioral recommendations to improve sleep-related behaviors weekly over 60 minutes for 4 weeks.
After completion of study intervention, patients are followed up at 7 days.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Miami Miller School of Medicine-Sylvester Cancer Center
Principal InvestigatorYoungmee Kim
