Sleep and Survival in Colorectal Cancer

Depression Clinical Trial

Official title:

Sleep-wake Rhythm in the Perioperative Period in Patients Admitted for Elective Radical Surgery for Colorectal Cancer: an Observational Prospective Cohort Study.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03254836
• Other study ID #: MTM-V3
• Secondary ID: SJ-600
• Status: Active, not recruiting
• Start date: March 1, 2017
• Est. completion date: July 31, 2023

Study information

• Verified date: January 2019
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Circadian Rhythm Sleep Disorder
• Colorectal Neoplasm
• Colorectal Neoplasms
• Depression
• Parasomnias
• Quality of Life
• Sleep
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders

Intervention

Other:
• Standard of care
Elective radical surgery for adenocarcinoma.

Locations

Country	Name	City	State
Denmark	Department of Surgery, Zealand University Hospital	Roskilde	Zealand

Sponsors (2)

Lead Sponsor	Collaborator
Zealand University Hospital	Center of Surgical Science, Department of Surgery, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Actigraphy	Assessment of activity using accelerometor - Sleep and circadian assesment.	Approximately 1 week preoperatively to 2 weeks postoperatively
Secondary	Major Depression Inventory	Assesment of depression	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.
Secondary	Insomnia Severity Index	Subjective sleep 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.
Secondary	Quality of life assesment	EORCT-QLQ-C30	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.
Secondary	Quality of life assesment	EORCT-QLQ-CR29	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.
Secondary	Mortality	Baseline registration and follow-up assessments	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.
Secondary	Co-morbidity	Baseline registration and follow-up assessments	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.
Secondary	Drug prescription history (Drug name and dosage)	Baseline registration and follow-up assessments	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.
Secondary	Follow-up cancer treatment (Adjuvant chemotherapy, timing and duration)	Baseline registration and follow-up assessments	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.