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Completed

NCT Number: NCT06023654

Identifying 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.

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Key information

Conditions

Cancer Accelerometry Activity, Motor Behavior Chronobiology Disorders Circadian Rhythm Disorders Mental Disorders Motor Activity Neoplasms Nervous System Diseases Parasomnias Sleep Disturbance Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Our Lady's Hospice & Care Services, Dublin, Ireland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

    Time frame: Time 1 (baseline), Time 2 (after 72 consecutive hours of accelerometry monitoring)

    Assessing the sensitivity and specificity of the screening tool

Secondary outcomes

  1. 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)

    Assessing the correlation between scores from the screening tool at two time points

  2. 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)

    Patient ease of use, understandability, acceptability and time to complete.

  3. 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)

    Patient ease of use, understandability, and acceptability

  4. 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)

    Incidence of Circadian rest-Activity Rhythm Disorders as identified by diagnostic criteria

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

    Time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)

    Combined assessment using wrist and thigh accelerometry alongside a sleep and activity diary

  6. 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)

    Baseline demographic details collected using a questionnaire

  7. 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)

    Past medical history collected using a questionnaire

  8. 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)

    Current medication use collected using a questionnaire

  9. 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)

    Chronotype assessed using the Morningness-Eveningness Questionnaire (MEQ)

  10. 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)

    Occupation provided by participant using a questionnaire

  11. 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

    Number and timing of last cigarette smoked each day assessed using a patient diary

  12. 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

    Number and timing of alcoholic beverages consumed each day assessed using a patient diary

  13. 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

    Number and timing of last of caffeinated drink consumed each day assessed using a patient diary

  14. 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)

    Symptoms measured using the Memorial Symptom Assessment Scale - Short Form (MSAS-SF)

  15. 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)

    Prognosis measured using the Prognosis in Palliative Care tool (PiPS-B)

  16. 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)

    Quality of Life measured using the EORTC Quality of Life Questionnaire (EORTC-QLQ-C30)

  17. 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)

    Sleep quality measured using the brief Pittsburgh Sleep Quality Instrument (bPSQI)

  18. 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)

    Daytime sleepiness assess using the Epworth Sleepiness Scale

Sponsors and collaborators

Lead sponsor

University of Dublin, Trinity College

Other

Collaborators

  • Our Lady's Hospice and Care Services

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 5, 2023
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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