NCT04712604

Brief Summary

The purpose of this study is to test feasibility and acceptability of a psycho-behavioral intervention on sleep in cancer patients and their partners.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 14, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2022

Completed
Last Updated

March 10, 2022

Status Verified

February 1, 2022

Enrollment Period

11 months

First QC Date

January 13, 2021

Last Update Submit

February 22, 2022

Conditions

Insomnia

Keywords

Sleep disturbance in GI cancer patients and their sleep partner

Outcome Measures

Primary Outcomes (2)

  • Feasibility of the intervention

    Feasibility of the intervention will be reported as the percentage of participants who enroll and complete all the sessions of the study.

    4 weeks

  • Acceptability of the intervention

    Acceptability of the intervention will be reported as the percentage of participants who evaluated the intervention and the interventionist as "satisfactory" or better.

    4 weeks

Secondary Outcomes (2)

  • Change in sleep disturbance

    Baseline, 4 weeks

  • Change in quality of life

    Baseline, 4 weeks

Study Arms (1)

MSOS Group

EXPERIMENTAL

The participants in this group will receive the MSOS Intervention for 4 consecutive weeks.

Behavioral: My Sleep Our Sleep (MSOS) Program

Interventions

My Sleep Our Sleep (MSOS) ProgramBEHAVIORAL

MSOS Program is a weekly one-hour Zoom session that focuses on psychoeducation on sleep health for both patients and their sleep partners.

MSOS Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients:
  • newly diagnosed with a gastrointestinal cancer (stage I to IV) 12 months or less prior to participating
  • years or older
  • able to speak/read English at the 5th grade level
  • having a consistent partner who is involved in daily activities including sleep
  • having 5 or greater score on the Pittsburgh Sleep Quality Index.
  • Sleep partners:
  • years or older
  • able to speak/read English at the 5th grade level
  • a partner of the patient who is involved in the patient's daily activities including sleep
  • having similar circadian rhythm/sleep patterns with the patient
  • having 5 or greater score on the Pittsburgh Sleep Quality Index.

You may not qualify if:

  • Patients and their sleep partners:
  • having had a diagnosis of dementia, psychotic disorder, major depressive disorder, bipolar disorder, which currently has not been treated
  • having active suicidality in the past year
  • currently having an untreated diagnosed sleep disorder (narcolepsy, restless leg syndrome)
  • currently having have a poor physical functioning status as measured by an Eastern Cooperative Oncology Group (ECOG) score of 3 or higher and Karnofsky grade of 50 or lower
  • having poor cognitive function status as measured by the Mini Mental State Examination score of 24 or less
  • unable to see or hear
  • at the end of life (life expectancy of less than a month)
  • unwilling to change their current sleep-related habits in near future.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (2)

  • Kim Y, Ting A, Tsai TC, Carver CS. Dyadic sleep intervention for adult patients with cancer and their sleep-partner caregivers: A feasibility study. Palliat Support Care. 2024 Apr;22(2):226-235. doi: 10.1017/S1478951523000627.

    PMID: 37312582DERIVED

  • Kim Y, Ting A, Steel JL, Tsai TC. Protocol of a dyadic sleep intervention for adult patients with cancer and their sleep-partner caregivers. Contemp Clin Trials Commun. 2023 Jan 16;32:101064. doi: 10.1016/j.conctc.2023.101064. eCollection 2023 Apr.

    PMID: 36704757DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Youngmee Kim, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 13, 2021

First Posted

January 15, 2021

Study Start

March 14, 2021

Primary Completion

January 25, 2022

Study Completion

January 25, 2022

Last Updated

March 10, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)