CancerNCT06023654
Identifying Circadian Rest-Activity Rhythm Disorders in Patients With Advanced Cancer
An observational study of Cancer and Circadian Rhythm Disorders, run by University of Dublin, Trinity College at 2 sites in Ireland.
Trial summary
Circadian rest-Activity Rhythm disorders (CARDs) are common in patients with cancer, particularly in advanced disease. CARDs are associated with increased symptoms, poorer quality of life, poorer response to anticancer treatments and shorter survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Circadian Rhythm Disorders, Sleep Disturbance
- How many people
- 100 participants
- Where
- 2 sitesIreland
- Study dates
- 15 May 2023to 22 May 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with locally advanced or metastatic cancer
Who may be able to join
- Adult (18 years of age or older)
- Locally advanced or metastatic cancer
- Outpatient
- Ambulatory
- Prognosis of 3 months or more
Who cannot join
- Inpatient
- Shiftworker
- Recent long-haul travel
- Cognitive impairment impacting on ability to complete questionnaires
Trial locations and contacts
2 sites in 1 country.
Ireland2 sites
Our Lady's Hospice & Care Services
Dublin
St James's Hospital
Dublin
About this study
Official title: Preliminary Validation of a Novel Screening Tool and Diagnostic Criteria to Identify Circadian Rest-Activity Rhythm Disorders in Patients With Advanced Cancer
Circadian rest-Activity Rhythm disorders (CARDs) are common in patients with cancer, particularly in advanced disease. CARDs are associated with increased symptoms, poorer quality of life, poorer response to anticancer treatments and shorter survival.
The goal of this observational study is to see how common CARDs are in patients with advanced cancer and to characterise their rest and activity patterns in more detail.
Read more
A recent study has outlined a standard way to assess and diagnose a CARD.
This study aims to assess patients with advanced cancer for a CARD using a novel screening tool against this newly formed diagnostic criteria. Potentially modifiable risk factors will be considered along with associations between CARDs and symptoms, sleep preferences, sleep quality, daytime sleepiness, quality of life measures and predictors of survival.
- Medical subject headings
- Neoplasms, Chronobiology Disorders, Parasomnias, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure preliminary concurrent validity of a novel screening tool to identify Circadian rest-Activity Rhythm Disorders in patients with advanced cancer against diagnostic criteria
Assessing the sensitivity and specificity of the screening tool
Measured: Time 1 (baseline), Time 2 (after 72 consecutive hours of accelerometry monitoring)
Secondary outcomes (18)
To measure test-retest reliability of a novel screening tool to identify Circadian rest-Activity Rhythm Disorders in patients with advanced cancer
Assessing the correlation between scores from the screening tool at two time points
Measured: Time 1 (baseline), Time 2 (after 72 consecutive hours of accelerometry monitoring)
To measure acceptability and ease of use of a novel screening tool to identify Circadian rest-Activity Rhythm Disorders in patients with advanced cancer
Patient ease of use, understandability, acceptability and time to complete.
Measured: Time 2 (after 72 consecutive hours of accelerometry monitoring)
To measure acceptability and ease of use of a novel sleep and activity diary in patients with advanced cancer
Patient ease of use, understandability, and acceptability
Measured: Time 2 (after 72 consecutive hours of accelerometry monitoring)
To identify the incidence of Circadian rest-activity Rhythm Disorders in patients with advanced cancer
Incidence of Circadian rest-Activity Rhythm Disorders as identified by diagnostic criteria
Measured: Time 2 (after 72 consecutive hours of accelerometry monitoring)
To assess rest and physical activity patterns in patients with advanced cancer
Combined assessment using wrist and thigh accelerometry alongside a sleep and activity diary
Measured: Time 2 (after 72 consecutive hours of accelerometry monitoring)
To assess the relationship between demographic details and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
Baseline demographic details collected using a questionnaire
Measured: Time 2 (after 72 consecutive hours of accelerometry monitoring)
To assess the relationship between past medical history and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
Past medical history collected using a questionnaire
Measured: Time 2 (after 72 consecutive hours of accelerometry monitoring)
To assess the relationship between current medication use and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
Current medication use collected using a questionnaire
Measured: Time 2 (after 72 consecutive hours of accelerometry monitoring)
To assess the relationship between chronotype and the risk of develop a Circadian rest-Activity Rhythms in patients with cancer
Chronotype assessed using the Morningness-Eveningness Questionnaire (MEQ)
Measured: Time 2 (after 72 consecutive hours of accelerometry monitoring)
To assess the relationship between occupation and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
Occupation provided by participant using a questionnaire
Measured: Time 2 (after 72 consecutive hours of accelerometry monitoring)
To assess the relationship between cigarette use and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
Number and timing of last cigarette smoked each day assessed using a patient diary
Measured: During 72 hours period of monitoring
To assess the relationship between alcohol consumption and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
Number and timing of alcoholic beverages consumed each day assessed using a patient diary
Measured: During 72 hours period of monitoring
To assess the relationship between caffeine consumption and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
Number and timing of last of caffeinated drink consumed each day assessed using a patient diary
Measured: During 72 hours period of monitoring
To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with symptoms
Symptoms measured using the Memorial Symptom Assessment Scale - Short Form (MSAS-SF)
Measured: Time 2 (after 72 consecutive hours of accelerometry monitoring)
To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer and prognosis
Prognosis measured using the Prognosis in Palliative Care tool (PiPS-B)
Measured: Time 2 (after 72 consecutive hours of accelerometry monitoring)
To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with quality of life
Quality of Life measured using the EORTC Quality of Life Questionnaire (EORTC-QLQ-C30)
Measured: Time 2 (after 72 consecutive hours of accelerometry monitoring)
To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with sleep quality
Sleep quality measured using the brief Pittsburgh Sleep Quality Instrument (bPSQI)
Measured: Time 2 (after 72 consecutive hours of accelerometry monitoring)
To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with daytime sleepiness
Daytime sleepiness assess using the Epworth Sleepiness Scale
Measured: Time 2 (after 72 consecutive hours of accelerometry monitoring)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start15 May 2023
- Primary completion15 May 2024
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- Our Lady's Hospice and Care Services
- Responsible party
- Principal investigator, Prof Andrew Davies, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023654
- Sponsor's protocol ID
- 1926A
- Status last verified
- Mar 2025
- First submitted
- 9 Sep 2022
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Validation of a Novel Screening Tool and Diagnostic Criteria to Identify Circadian Rest-Activity Rhythm Disorders in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT06023654
- Acronym / sponsor ID
- 1926A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- Our Lady's Hospice and Care Services
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 5 Sep 2023 (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.
Circadian rest-Activity Rhythm disorders (CARDs) are common in patients with cancer, particularly in advanced disease. CARDs are associated with increased symptoms, poorer quality of life, poorer response to anticancer treatments and shorter survival.
The goal of this observational study is to see how common CARDs are in patients with advanced cancer and to characterise their rest and activity patterns in more detail.
A recent study has outlined a standard way to assess and diagnose a CARD.
This study aims to assess patients with advanced cancer for a CARD using a novel screening tool against this newly formed diagnostic criteria. Potentially modifiable risk factors will be considered along with associations between CARDs and symptoms, sleep preferences, sleep quality, daytime sleepiness, quality of life measures and predictors of survival.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced or metastatic cancer
Key inclusion criteria (5 listed)
- Adult (18 years of age or older)
- Locally advanced or metastatic cancer
- Outpatient
- Ambulatory
- Prognosis of 3 months or more
Key exclusion criteria (4 listed)
- Inpatient
- Shiftworker
- Recent long-haul travel
- Cognitive impairment impacting on ability to complete questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To measure preliminary concurrent validity of a novel screening tool to identify Circadian rest-Activity Rhythm Disorders in patients with advanced cancer against diagnostic criteria
Time frame: Time 1 (baseline), Time 2 (after 72 consecutive hours of accelerometry monitoring)
Assessing the sensitivity and specificity of the screening tool
18 secondary outcomes
To measure test-retest reliability of a novel screening tool to identify Circadian rest-Activity Rhythm Disorders in patients with advanced cancer
Time frame: Time 1 (baseline), Time 2 (after 72 consecutive hours of accelerometry monitoring)
To measure acceptability and ease of use of a novel screening tool to identify Circadian rest-Activity Rhythm Disorders in patients with advanced cancer
Time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
To measure acceptability and ease of use of a novel sleep and activity diary in patients with advanced cancer
Time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
To identify the incidence of Circadian rest-activity Rhythm Disorders in patients with advanced cancer
Time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
To assess rest and physical activity patterns in patients with advanced cancer
Time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
To assess the relationship between demographic details and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
Time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
To assess the relationship between past medical history and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
Time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
To assess the relationship between current medication use and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
Time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
To assess the relationship between chronotype and the risk of develop a Circadian rest-Activity Rhythms in patients with cancer
Time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
To assess the relationship between occupation and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
Time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
To assess the relationship between cigarette use and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
Time frame: During 72 hours period of monitoring
To assess the relationship between alcohol consumption and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
Time frame: During 72 hours period of monitoring
To assess the relationship between caffeine consumption and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
Time frame: During 72 hours period of monitoring
To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with symptoms
Time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer and prognosis
Time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with quality of life
Time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with sleep quality
Time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with daytime sleepiness
Time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Circadian Rhythm Disorders, run by University of Dublin, Trinity College at 2 sites in Ireland.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To measure preliminary concurrent validity of a novel screening tool to identify Circadian rest-Activity Rhythm Disorders in patients with advanced cancer against diagnostic criteria (time frame: Time 1 (baseline), Time 2 (after 72 consecutive hours of accelerometry monitoring)). 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 3 Apr 2025.