Colorectal NeoplasmNCT03254836
Sleep and Survival in Colorectal Cancer
An observational study of Colorectal Neoplasm and Circadian Rhythm Sleep Disorder, run by Zealand University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasm, Circadian Rhythm Sleep Disorder, Depression
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2017to 31 Jul 2023
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All patients eligible for elective curative intended surgery for colonic or rectal adenocarcinoma at Zealand University Hospital.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Surgery, Zealand University Hospital
Roskilde, Region Sjælland, 4000
About this study
Official title: Sleep-wake Rhythm in the Perioperative Period in Patients Admitted for Elective Radical Surgery for Colorectal Cancer: an Observational Prospective Cohort Study.
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.
Read more
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.
- Being tested
- Standard of care
- Keywords
- Actigraphy, Major Depression Inventory (MDI), Insomnia Severity Index (ISI)
- Medical subject headings
- Colorectal Neoplasms, Sleep Disorders, Circadian Rhythm, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
Elective radical surgery for adenocarcinoma.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actigraphy
Assessment of activity using accelerometor - Sleep and circadian assesment.
Measured: Approximately 1 week preoperatively to 2 weeks postoperatively
Secondary outcomes (8)
Major Depression Inventory
Assesment of depression
Measured: 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
Subjective sleep assesment
Measured: 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
EORCT-QLQ-C30
Measured: 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
EORCT-QLQ-CR29
Measured: 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 registration and follow-up assessments
Measured: 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.
Co-morbidity
Baseline registration and follow-up assessments
Measured: 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.
Drug prescription history (Drug name and dosage)
Baseline registration and follow-up assessments
Measured: 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.
Follow-up cancer treatment (Adjuvant chemotherapy, timing and duration)
Baseline registration and follow-up assessments
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start1 Mar 2017
- Primary completion31 Jul 2018
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Center of Surgical Science, Department of Surgery, Zealand University Hospital
- Responsible party
- Principal investigator, Michael Tvilling Madsen, Zealand University Hospital
- Investigators
- Michael T Madsen, M.D., Principal investigator, Department of Surgery, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254836
- Sponsor's protocol ID
- MTM-V3
- Other IDs
- SJ-600
- Status last verified
- Jan 2019
- First submitted
- 15 Aug 2017
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Contact to study investigators avaliable at mitm@regionsjaelland.dk
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep-wake Rhythm in the Perioperative Period in Patients Admitted for Elective Radical Surgery for Colorectal Cancer: an Observational Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT03254836
- Acronym / sponsor ID
- MTM-V3
- Keywords
- Actigraphy, Major Depression Inventory (MDI), Insomnia Severity Index (ISI)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Center of Surgical Science, Department of Surgery, Zealand University Hospital
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 21 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal cancer undergoing elective surgery | – | Other: Standard of careAll patients eligible for elective curative intended surgery for colonic adenocarcinoma at Zealand University Hospital. Patients will recieve treatment as per standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients eligible for elective curative intended surgery for colonic or rectal adenocarcinoma at Zealand University Hospital.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of careElective radical surgery for adenocarcinoma. | Other | Colorectal cancer undergoing elective surgery |
Primary outcome
Actigraphy
Time frame: Approximately 1 week preoperatively to 2 weeks postoperatively
Assessment of activity using accelerometor - Sleep and circadian assesment.
8 secondary outcomes
Major Depression Inventory
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Co-morbidity
Time frame: 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.
Drug prescription history (Drug name and dosage)
Time frame: 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.
Follow-up cancer treatment (Adjuvant chemotherapy, timing and duration)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Individual participant dataSharing planned: Undecided. Contact to study investigators avaliable at mitm@regionsjaelland.dk
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael T Madsen, M.D. principal investigator
Department of Surgery, Zealand University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasm and Circadian Rhythm Sleep Disorder, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actigraphy (time frame: Approximately 1 week preoperatively to 2 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.