Identifying Circadian Rest-Activity Rhythm Disorders in Patients With Advanced Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Preliminary Validation of a Novel Screening Tool and Diagnostic Criteria to Identify Circadian Rest-Activity Rhythm Disorders in Patients With Advanced Cancer

Conditions
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Cancer, Circadian Rhythm Disorders, Sleep Disturbance, Activity, Motor, Accelerometry

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Time 1 (baseline), Time 2 (after 72 consecutive hours of accelerometry monitoring) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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) | 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 | Time 2 (after 72 consecutive hours of accelerometry monitoring) |