Clinical trial · Interventional
A Feasibility Trial for Circadian Rest-activity Rhythm Disorders in Cancer (RALI)
The RALI Study: a Multimodal Non-pharmacological (Clinical Review, Physical Activity, Bright Light Therapy and Cognitive Behavioural Therapy for Insomnia) Feasibility Trial for 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 are common in patients with cancer, particularly in advanced disease. A recent international e-Delphi study has outlined recommendations for the assessment and reporting of the disorder and subsequently an observation study is underway assessing a cohort of patients with advanced cancer. Affected patients are eligible to enter a feasibility study assessing a non-pharmacological multi-modal intervention.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Circadian Rhythm Disorders | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bright Light Therapy | Device | — | UNRESOLVED |
| Clincial review | Other | — | UNRESOLVED |
| Cognitive behavioural therapy for Insomnia (CBT-I) | Behavioral | — | UNRESOLVED |
| Individualised activity plan | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Multi-modal intervention
- description
- Single arm study receiving a multi-modal intervention
- interventionNames
- Behavioral: Cognitive behavioural therapy for Insomnia (CBT-I)
- Device: Bright Light Therapy
- Behavioral: Individualised activity plan
- Other: Clincial review
Primary outcomes (5)
- measure
- Acceptability and usability of a multi-modal non-pharmacological intervention
- timeFrame
- At the end of 8-weeks
- description
- Patient completed questionnaire of the acceptability and usability of interventions and research assessments
- measure
- Adherence to interventions
- timeFrame
- Outcome assessed weekly during the 8-week trial
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18 years old 2. Outpatient 3. Diagnosis of advanced cancer (locally advanced, incurable, metastatic) 4. Ambulatory 5. Estimated prognosis ≥ 3 months 6. Evidence of a circadian rest-activity rhythm disorder Exclusion Criteria: 1. Inpatient 2. Engaged in shift-work 3. Long-haul travel in the last 14 days 4. Physical impairment limiting movement of the non-dominant arm 5. Cognitive impairment limiting the ability to complete the assessment tool and/or patient diary 6. Uncontrolled high blood pressure or tachycardia 7. Exercise-related symptoms and signs (e.g. chest pain, syncope, limb claudication, hypoxia at rest) 8. Participant has a history of uncontrolled mania or bipolar disorder 9. Participant has a recent history or current thoughts of self-harm or suicide 10. Participant has a recent change in antidepressant medication 11. Participant has an eye disorder (e.g. glaucoma, cataracts, retinopathy)
References
Publications (0)
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