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

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

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05044312
Enrollment
0
Registered
2021-09-14
Start date
2020-03-06
Completion date
2026-01-15
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Cancer, GI Cancers

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

Interventions

OTHERSleeping 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.

Sponsors

M.D. Anderson Cancer Center
Lead SponsorOTHER
American Cancer Society, Inc.
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Correlating the sleep disturbance and its types among patients with gastrointestinal cancers.through study completion, an average of 1 yearThis 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

Contacts

PRINCIPAL_INVESTIGATORSriram Yennu

M.D. Anderson Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026