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

Gastrointestinal Cancer Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Dyssomnias
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Parasomnias

• NCT number: NCT05044312
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Contact: Sriram Yennu
• Phone: 713-792-3938
• Email: syennu@mdanderson.org
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 30, 2024
• Completion date: December 30, 2026