Sleep Disturbances in Surgical Patients With GI Cancers:... | NCT05044312

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

NCT05044312

Sponsor

M.D. Anderson Cancer Center

Status

Withdrawn

Last Update Posted

Jan 23, 2026Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

GI Cancers
Gastrointestinal Cancer

Interventions

Sleeping Disturbances

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2021-09807	Other Identifier	Clinical Trials Reporting Program (CTRP)

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI requested

Expanded Access Info

Start Date

Mar 6, 2020Estimated

Primary Completion Date

Jan 15, 2026Actual

Completion Date

Jan 15, 2026Actual

First Submitted Date

Sep 9, 2021

First Submission Date that Met QC Criteria

Sep 9, 2021

First Posted Date

Sep 14, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2026

Last Update Posted Date

Jan 23, 2026Actual

Name	Class
American Cancer Society, Inc.	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sleep Disturbances	Other	Difficulty Sleeping	Other: Sleeping Disturbances

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sleeping Disturbances	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult GI Cancer patients admitted for elective gastrointestinal surgery.
Patients with an expected hospitalstay of at least 72 hours.
Able to be able to read and speak English.
Must have access to internet or use of mobile device for FitBit.

Exclusion Criteria:

<18 years of age.
Night shift workers. Obtained from job history, any patient >/= 2 days per week, within the last six months prior consenting, are not eligible.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sriram Yennu	M.D. Anderson Cancer Center	Principal Investigator

Locations

Not provided

Label	URL
M D Anderson Cancer Center website	View source

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	May 14, 2020	Jan 21, 2026	ICF_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D005770	Gastrointestinal Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided