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Completed

NCT Number: NCT04712604

Feasibility and Acceptability Study of My Sleep Our Sleep (MSOS) Program

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

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients:

  • newly diagnosed with a gastrointestinal cancer (stage I to IV) 12 months or less prior to participating
  • 18 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:

  • 18 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.

Exclusion criteria

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.

Treatment and study plan

My Sleep Our Sleep (MSOS) Program

Behavioral

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

Primary outcomes

  1. Feasibility of the intervention

    Time frame: 4 weeks

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

  2. Acceptability of the intervention

    Time frame: 4 weeks

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

Secondary outcomes

  1. Change in sleep disturbance

    Time frame: Baseline, 4 weeks

    Change in sleep disturbance as measured by the Pittsburgh Sleep Quality Index (PSQI). PSQI has a total score ranging from 0 to 21, where lower score indicates healthier sleep quality.

  2. Change in quality of life

    Time frame: Baseline, 4 weeks

    Change in quality of life as measured by the Patient-reported Outcomes Measurement Information System (PROMIS-29). PROMIS-29 has a total score ranging from 20-80, with lower scores indicating better quality of life.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 15, 2021
Registry last updated
Mar 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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