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

NCT06023654 | Completed

• 1 other identifier: 1926A
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• To measure test-retest reliability of a novel screening tool to identify Circadian rest-Activity Rhythm Disorders in patients with advanced cancer

  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 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 2 (after 72 consecutive hours of accelerometry monitoring)

• To identify the incidence of Circadian rest-activity Rhythm Disorders in patients with advanced cancer

  Time 2 (after 72 consecutive hours of accelerometry monitoring)

• To assess rest and physical activity patterns in patients with advanced cancer

  Time 2 (after 72 consecutive hours of accelerometry monitoring)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with locally advanced or metastatic cancer

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (2)

Our Lady's Hospice & Care Services

Dublin, Ireland

Location

St James's Hospital

Dublin, Ireland

Location

MeSH Terms

Conditions

Neoplasms; Chronobiology Disorders; Parasomnias; Motor Activity

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Wake Disorders; Mental Disorders; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Palliative Medicine

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 5, 2023
• Study Start: May 15, 2023
• Primary Completion: May 15, 2024
• Study Completion: May 22, 2024
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

IE (2)