Study Stopped
PI requested
Sleep Disturbances in Surgical Patients With GI Cancers: A Quantitative and Qualitative Analysis
2 other identifiers
interventional
N/A
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2020
Longer than P75 for not_applicable
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
CompletedFirst Submitted
Initial submission to the registry
September 9, 2021
CompletedFirst Posted
Study publicly available on registry
September 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2026
CompletedJanuary 23, 2026
January 1, 2026
5.9 years
September 9, 2021
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
OTHERDifficulty Sleeping
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.
Eligibility Criteria
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
- M.D. Anderson Cancer Centerlead
- American Cancer Society, Inc.collaborator
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sriram Yennu
M.D. Anderson Cancer Center
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