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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05044312
• Other study ID #: 2019-1182
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 30, 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: February 2024
• Source: M.D. Anderson Cancer Center
• Contact: Sriram Yennu
• Phone: 713-792-3938
• Email: syennu[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult GI Cancer patients admitted for elective gastrointestinal surgery.

2. Patients with an expected hospitalstay of at least 72 hours.

3. Able to be able to read and speak English.

4. Must have access to internet or use of mobile device for FitBit.

Exclusion Criteria:

1. <18 years of age.

2. Night shift workers. Obtained from job history, any patient >/= 2 days per week, within the last six months prior consenting, are not eligible.

Related Conditions & MeSH terms

• Dyssomnias
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Parasomnias

Intervention

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.

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlating the sleep disturbance and its types among patients with gastrointestinal cancers.	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	through study completion, an average of 1 year

External Links

•   M D Anderson Cancer Center website