search
Back to results

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

Primary Purpose

GI Cancers, Gastrointestinal Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleeping Disturbances
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for GI Cancers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Sleep Disturbances

Arm Description

Difficulty Sleeping

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 9, 2021
Last Updated
August 9, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
American Cancer Society, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05044312
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
American Cancer Society, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GI Cancers, Gastrointestinal Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sleep Disturbances
Arm Type
Other
Arm Description
Difficulty Sleeping
Intervention Type
Other
Intervention Name(s)
Sleeping Disturbances
Intervention Description
most common complaints of patients after surgery and may affect the ability to carry out daily activities, quality of life, and post-surgery recovery.
Primary Outcome Measure Information:
Title
Correlating the sleep disturbance and its types among patients with gastrointestinal cancers.
Description
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
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sriram Yennu
Phone
713-792-3938
Email
syennu@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sriram Yennu
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sriram Yennu
Phone
713-792-3938
Email
syennu@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Sriram Yennu

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center website

Learn more about this trial

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

We'll reach out to this number within 24 hrs