Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Accelerometry | — | UNRESOLVED | — |
| Activity, Motor | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Circadian Rhythm Disorders | — | UNRESOLVED | — |
| Sleep Disturbance | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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
- timeFrame
- Time 1 (baseline), Time 2 (after 72 consecutive hours of accelerometry monitoring)
- description
- Assessing the sensitivity and specificity of the screening tool
Secondary outcomes (18)
- measure
- To measure test-retest reliability of a novel screening tool to identify Circadian rest-Activity Rhythm Disorders in patients with advanced cancer
- timeFrame
- Time 1 (baseline), Time 2 (after 72 consecutive hours of accelerometry monitoring)
- description
- Assessing the correlation between scores from the screening tool at two time points
- measure
- To measure acceptability and ease of use of a novel screening tool to identify Circadian rest-Activity Rhythm Disorders in patients with advanced cancer
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available