Sleep Disturbances in Surgical Patients With GI Cancers: A Quantitative and Qualitative Analysis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Correlating the sleep disturbance and its types among patients with gastrointestinal cancers.
Study Overview
Brief Summary
The primary objective of the study is to determine sleep disturbance and its types among patients with gastrointestinal cancers during the perioperative period (preoperative and in-hospital stay following surgery) by using Richard Campbell sleep questionnaire (RCSQ).
The primary objective of this study is to determine the SD during preoperative and post-operative periods evaluated by Richard Campbell Sleep questionnaire. Patients will be asked every 24 hours while at the hospital (before and after surgery) to fill out this questionnaire. The mean RCSQ score at each time point (i.e., before and after surgery) will be calculated for each patient. The overall mean (across all patients) will be calculated and reported along a 95% CI.
Detailed Description
Primary:
• Determine sleep disturbance and its types among patients with gastrointestinal cancers during the perioperative period (preoperative and in-hospital stay following surgery) by using Richard Campbell sleep questionnaire(RCSQ).
Secondary:
- Determine sleep disturbance and its types at 30 day post-discharge follow-up visit by RCSQ.
- Determine the correlation between objective sleep variables assessed using Actigraphy and Fitbit and patient-reported SD on Richard Campbell Sleep questionnaire.
- Determine the association of severity and impact of SD among Quality of recovery (QoR-15), Pittsburgh sleep quality index, MDASI-GI and Richard Campbell Sleep questionnaire, and Insomnia Severity Index (ISI).
Exploratory:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult GI Cancer patients admitted for elective gastrointestinal surgery.
- •Patients with an expected hospitalstay of at least 72 hours.
- •Able to be able to read and speak English.
- •Must have access to internet or use of mobile device for FitBit.
Exclusion Criteria
- •<18 years of age.
- •Night shift workers. Obtained from job history, any patient >/= 2 days per week, within the last six months prior consenting, are not eligible.
Arms & Interventions
Sleep Disturbances
Difficulty Sleeping
Intervention: Sleeping Disturbances (Other)
Outcomes
Primary Outcomes
Correlating the sleep disturbance and its types among patients with gastrointestinal cancers.
Time Frame: through study completion, an average of 1 year
This questionnaire will be used to assess during the stay by using (preoperative and in-hospital stay following surgery) by using Richard Campbell sleep questionnaire(RCSQ). scale of 1 to 10 (with 1 being "poor" and 10 being "excellent
Secondary Outcomes
No secondary outcomes reported