Clinical trial NCT05044312: Sleep Disturbances in Surgical Patients With GI Cancers: A Quantitative and Qualitative Analysis
Official title: Sleep Disturbances in Surgical Patients With GI Cancers: A Quantitative and Qualitative Analysis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: GI Cancers
Gastrointestinal Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2021-09-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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

Eligibility criteria: 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.

Primary outcomes:
measure: Correlating the sleep disturbance and its types among patients with gastrointestinal cancers.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Sriram Yennu
role: PRINCIPAL_INVESTIGATOR
References: