Gastrointestinal Cancer
Conditions
Brief summary
The purpose of this study is to learn about sleep behaviors and test different ways to help patients with cancer and caregiver partners.
Interventions
BEHAVIORALMy Sleep Our Sleep (MSOS) Program
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.
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 they spend 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.
Sponsors
University of Miami
National Institute of Nursing Research (NINR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in sleep disturbance symptoms as measured by scores on the Pittsburgh Sleep Quality Index (PSQI) | Baseline, Up to 13 weeks | Change in sleep disturbance symptoms (patient-sleep-partner caregiver dyads) among participants will be compared and reported for both intervention groups, BBTI and MSOS, as measured by scores on the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-reported, 19-item questionnaire health-related quality of life (HRQOL) questionnaire which assesses sleep quality and disturbances at baseline, week 5 and week 13. Questions generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. A decrease of ≥ 5 points on the PSQI) will be considered as clinical improvement of symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in insomnia symptoms as measured by scores on the Insomnia Severity Index (ISI) | Baseline, Up to 13 weeks | Change in insomnia symptoms among participants (patient-sleep-partner caregiver dyads) will be compared and reported for both intervention groups, BBTI and MSOS, as measured by scores on the 7-item Insomnia Severity Index (ISI). The ISI is a self-reported, health-related quality of life (HRQOL) questionnaire used to assess insomnia symptoms at baseline, week 5 and week 13. The dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, notice ability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item, ranging from 0 to 4 (e.g., 0 = no problem; 4 = very severe problem). The total score ranges from 0 to 28, the lower total score indicates a lower level of insomnia. Greater than a 6-point decrease on the ISI is considered substantial reduction in insomnia symptoms. |
Countries
United States
Contacts
CONTACTYoungmee Kim, PhD
PRINCIPAL_INVESTIGATORYoungmee Kim, PhD
University of Miami
Outcome results
None listed