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

Not Applicable

Not yet recruiting

• Conditions: GI Cancers; Gastrointestinal Cancer
• Interventions: Other: Sleeping Disturbances

• Registration Number: NCT05044312
• Lead Sponsor: M.D. Anderson Cancer Center

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:

• 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-09
• Study First Posted: 2021-09-14
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-19
• Study Start: 2024-09-30
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sleep Disturbances	Sleeping Disturbances	Difficulty Sleeping

Primary Outcome Measures

Name	Time	Method
Correlating the sleep disturbance and its types among patients with gastrointestinal cancers.	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

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States