NCT05044312

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2021

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

5.9 years

First QC Date

September 9, 2021

Last Update Submit

January 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Sleep Disturbances

OTHER

Difficulty Sleeping

Other: Sleeping Disturbances

Interventions

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

Sleep Disturbances

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \<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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • Sriram Yennu

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2021

First Posted

September 14, 2021

Study Start

March 6, 2020

Primary Completion

January 15, 2026

Study Completion

January 15, 2026

Last Updated

January 23, 2026

Record last verified: 2026-01