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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-06

Study Completion Date

2026-01-15

Brief Summary

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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.

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Detailed Description

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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

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GI Cancers Gastrointestinal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Sleep Disturbances

Difficulty Sleeping

Group Type OTHER

Sleeping Disturbances

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No