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

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.

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 Overview

• Status: Completed
• Conditions: Cancer; Sleep Disturbance; Circadian Rhythm Disorders; Activity, Motor; Accelerometry

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland
    • St James's Hospital
  • Dublin, Ireland
    • Our Lady's Hospice & Care Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with locally advanced or metastatic cancer

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Dublin, Trinity College
• Collaborators: Our Lady's Hospice and Care Services

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Actual): May 15, 2024
• Study Completion (Actual): May 22, 2024

Study Registration Dates

• First Submitted: September 9, 2022
• First Submitted That Met QC Criteria: September 1, 2023
• First Posted (Actual): September 5, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Chronobiology Disorders
• Other Study ID Numbers: 1926A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No