NCT05044312

Sleep Disturbances in Surgical Patients With GI Cancers: A Quantitative and Qualitative Analysis

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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: • Determine the association between the preoperative inflammatory burden, sleep health {insomnia (using Insomnia Severity Index (ISI)),sleep architecture(sleep-wake cycles usingActigraphy)}, and perioperative inflammatory responses on postoperative SD

Conditions

• GI Cancers
• Gastrointestinal Cancer

Interventions

Type	Name	Description
OTHER	Sleeping Disturbances	most common complaints of patients after surgery and may affect the ability to carry out daily activities, quality of life, and post-surgery recovery.

Timeline

• Start date: 2020-03-06
• Primary completion: 2026-01-15
• Completion: 2026-01-15
• First posted: 2021-09-14
• Last updated: 2026-01-23