Clinical trial NCT06023654: Identifying Circadian Rest-Activity Rhythm Disorders in Patients With Advanced Cancer
Official title: Preliminary Validation of a Novel Screening Tool and Diagnostic Criteria to Identify Circadian Rest-Activity Rhythm Disorders in Patients With Advanced Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Circadian Rhythm Disorders
Sleep Disturbance
Activity, Motor
Accelerometry
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
Collaborators: name: Our Lady's Hospice and Care Services
First posted: 2023-09-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with locally advanced or metastatic cancer

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* Adult (18 years of age or older)
* Locally advanced or metastatic cancer
* Outpatient
* Ambulatory
* Prognosis of 3 months or more

Exclusion Criteria:

* Inpatient
* Shiftworker
* Recent long-haul travel
* Cognitive impairment impacting on ability to complete questionnaires

Primary outcomes:
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
timeFrame: Time 1 (baseline), Time 2 (after 72 consecutive hours of accelerometry monitoring)
Secondary outcomes:
measure: To measure test-retest reliability of a novel screening tool to identify Circadian rest-Activity Rhythm Disorders in patients with advanced cancer
timeFrame: Time 1 (baseline), Time 2 (after 72 consecutive hours of accelerometry monitoring)
measure: To measure acceptability and ease of use of a novel screening tool to identify Circadian rest-Activity Rhythm Disorders in patients with advanced cancer
timeFrame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
measure: To measure acceptability and ease of use of a novel sleep and activity diary in patients with advanced cancer
timeFrame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
measure: To identify the incidence of Circadian rest-activity Rhythm Disorders in patients with advanced cancer
timeFrame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
measure: To assess rest and physical activity patterns in patients with advanced cancer
timeFrame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
measure: To assess the relationship between demographic details and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
timeFrame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
measure: To assess the relationship between past medical history and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
timeFrame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
measure: To assess the relationship between current medication use and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
timeFrame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
measure: To assess the relationship between chronotype and the risk of develop a Circadian rest-Activity Rhythms in patients with cancer
timeFrame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
measure: To assess the relationship between occupation and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
timeFrame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
measure: To assess the relationship between cigarette use and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
timeFrame: During 72 hours period of monitoring
measure: To assess the relationship between alcohol consumption and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
timeFrame: During 72 hours period of monitoring
measure: To assess the relationship between caffeine consumption and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
timeFrame: During 72 hours period of monitoring
measure: To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with symptoms
timeFrame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
measure: To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer and prognosis
timeFrame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
measure: To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with quality of life
timeFrame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
measure: To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with sleep quality
timeFrame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
measure: To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with daytime sleepiness
timeFrame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Our Lady's Hospice & Care Services
city: Dublin
country: Ireland
facility: St James's Hospital
Study officials:
References: