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

• Sponsor: University of Dublin, Trinity College (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06023654
• Collaborator: Our Lady's Hospice and Care Services (Other)
• Enrollment: 100
• Locations: 2
• Anticipated Duration (Months): 12.6
• Patients Per Site: 50
• Patients Per Site Per Month: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer; Circadian Rhythm Disorders; Sleep Disturbance; Activity, Motor; Accelerometry

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Preliminary Validation of a Novel Screening Tool and Diagnostic Criteria to Identify Circadian Rest-Activity Rhythm Disorders in Patients With Advanced Cancer
• Actual Study Start Date: May 15, 2023
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jun 1, 2024

Outcome Measures

Primary Outcome Measures

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

   Assessing the sensitivity and specificity of the screening tool

Secondary Outcome Measures

1. 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)]

   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 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 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 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 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 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 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 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 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 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 [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 [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 [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 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 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 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 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 2 (after 72 consecutive hours of accelerometry monitoring)]

    Daytime sleepiness assess using the Epworth Sleepiness Scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Our Lady's Hospice & Care Services	Dublin		Ireland
2	St James's Hospital	Dublin		Ireland

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof Andrew Davies, Professor of Palliative Medicine, University of Dublin, Trinity College
• ClinicalTrials.gov Identifier: NCT06023654
• Other Study ID Numbers: 1926A
• First Posted: Sep 5, 2023
• Last Update Posted: Sep 5, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dyssomnias; Parasomnias; Chronobiology Disorders

Study Results

No Results Posted as of Sep 5, 2023