CompletedNo phase
A Feasibility Trial for Circadian Rest-activity Rhythm Disorders in Cancer (RALI)
Key facts
- Who runs it
- University of Dublin, Trinity College
- Where
- Ireland2 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 30 people enrolled
- Started
- 1 Jun 2023
- Ended
- 26 Aug 2024
- Type of study
- Interventional
- Treatments tested
- Cognitive behavioural therapy for Insomnia (CBT-I)
- Bright Light Therapy
- Individualised activity plan
- Clincial review
- Record updated
- 3 April 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- Age ≥18 years old
- Outpatient
- Diagnosis of advanced cancer (locally advanced, incurable, metastatic)
- Ambulatory
- Estimated prognosis ≥ 3 months
- Evidence of a circadian rest-activity rhythm disorder
Who cannot take part
- Participant has a recent change in antidepressant medication
- Physical impairment limiting movement of the non-dominant arm
- Cognitive impairment limiting the ability to complete the assessment tool and/or patient diary
- Participant has a history of uncontrolled mania or bipolar disorder
- Participant has an eye disorder (e.g. glaucoma, cataracts, retinopathy)
- Inpatient
- Engaged in shift-work
- Long-haul travel in the last 14 days
- Uncontrolled high blood pressure or tachycardia
- Exercise-related symptoms and signs (e.g. chest pain, syncope, limb claudication, hypoxia at rest)
- Participant has a recent history or current thoughts of self-harm or suicide
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The group in the trial
- Multi-modal interventionTreatment being tested
Single arm study receiving a multi-modal intervention
Treatment: Cognitive behavioural therapy for Insomnia (CBT-I), Bright Light Therapy, Individualised activity plan, and Clincial review
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Record updated
- 3 April 2025