Sleep and Survival in Colorectal Cancer

NCT03254836 | Unknown

• 2 other identifiers: MTM-V3SJ-600
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Objective The objective of the current trial is to investigate the effect of perioperative sleep and circadian rhythm on the natural course of survival among patient diagnosed with colorectal cancer. Concurrently, outcome measures like depression, fatigue, quality of life, and co-morbidity will be measured continuously in the short-, intermediate- and long-term period following diagnosis. The a-priori hypothesis is that preoperative sleep and circadian disturbances is a prognostic marker of reduced overall survival. Likewise, preoperative sleep-wake disturbances at baseline are expected to result in overall universally reduced quality of life, increased depression and fatigue. Furthermore, development of sleep-wake disturbances in the postoperative period as compared to preoperative sleep-wake rhythm is expected to a prognostic marker of negative outcomes. Target and study population The study population are all patients diagnosed with colorectal cancer in Region Zealand recruited consecutively from the trial initiation until study end each patient with an intended 5 year follow-up period. All available cases will be included in the trial. Study design The study will be an observational prospective cohort study applying a longituditional repeated measure design. Exposures and outcomes of interest The primary outcomes in the trial are sleep and circadian outcomes measured via actigraphy in the perioperative period. Furthermore, cancer related survival and overall survival in the 5 year follow-up period is considered primary outcomes. Secondary outcomes consist of consecutively measured depression, fatigue, quality of life, follow-up treatment and co-morbidity. Exposure variables are primary related to the cancer, i.e. cancer stage, surgical treatment, oncological treatment, baseline co-morbidity and pharmacological treatment. Some of the secondary outcomes could be expected to serve as confounding or mediating factors. Meaningful control for confounding will in the analysis phase be cancer stage and baseline sleep-wake rhythm status. Sampling methods All available cases will be sought included in the trial. No formal sample size has been performed and continues inclusion into the trial will be performed during an 1,5 year period. Statistical analyses The relationship between overall survival and baseline sleep-wake rhythm will be investigated using survival statistics and/or multivariate logistic regression. Expected results The investigators expect to see a marked difference in overall survival among patients with sleep and circadian disturbances at baseline.

Conditions

Colorectal Neoplasm; Circadian Rhythm Sleep Disorder; Depression; Quality of Life; Sleep

Keywords

Actigraphy; Major Depression Inventory (MDI); Insomnia Severity Index (ISI)

Outcome Measures

Primary Outcomes (1)

• Actigraphy

  Assessment of activity using accelerometor - Sleep and circadian assesment.

  Approximately 1 week preoperatively to 2 weeks postoperatively

Secondary Outcomes (8)

• Major Depression Inventory

  Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively.

• Insomnia Severity Index

  Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively.

• Quality of life assesment

  Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively.

• Quality of life assesment

  Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively.

• Mortality

  Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively.

Study Arms (1)

Colorectal cancer undergoing elective surgery

All patients eligible for elective curative intended surgery for colonic adenocarcinoma at Zealand University Hospital. Patients will recieve treatment as per standard of care.

Other: Standard of care

Interventions

Standard of care OTHER

Elective radical surgery for adenocarcinoma.

Colorectal cancer undergoing elective surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients eligible for elective curative intended surgery for colonic or rectal adenocarcinoma at Zealand University Hospital.

You may qualify if:

• Diagnosis of colorectal cancer as determined at the multi-disciplinary team conference.
• Admitted to elective radical surgery at the department of surgery at Zealand University Hospital
• Age above 18 years
• Informed consent

You may not qualify if:

• Non-ability to complete the study as assessed by the investigator
• Non-fluent in Danish.
• History of cognitive impairment (e.g. dementia)
• Paralysis or inability to answer study questioners electronically.
• Stadium 4 colonic adenocarcinoma with no surgical treatment options as determined at the multi-disciplinary conference.

Sponsors & Collaborators

• Zealand University Hospital: lead
• Center of Surgical Science, Department of Surgery, Zealand University Hospital: collaborator

Study Sites (1)

Department of Surgery, Zealand University Hospital

Roskilde, Region Sjælland, 4000, Denmark

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Sleep Disorders, Circadian Rhythm; Depression

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Michael T Madsen, M.D.

  Department of Surgery, Zealand University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 21, 2017
• Study Start: March 1, 2017
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2023
• Last Updated: January 15, 2019

Record last verified: 2019-01

Locations

DK (1)