Clinical trial NCT06329479: A Feasibility Trial for Circadian Rest-activity Rhythm Disorders in Cancer (RALI)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Circadian Rhythm Disorders
Cancer
Keywords: circadian rest-activity rhythms
advanced cancer
feasibility trial
multi-modal
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Acceptability and usability of a multi-modal non-pharmacological intervention
timeFrame: At the end of 8-weeks
measure: Adherence to interventions
timeFrame: Outcome assessed weekly during the 8-week trial
measure: Adverse events
timeFrame: Outcome assessed weekly during an 8-week trial
measure: Completion rates of research assessments
timeFrame: Completed at baseline, week 2, week 4 and week 8
measure: Recruitment rate
timeFrame: 1 year
Secondary outcomes:
measure: Symptom assessment
timeFrame: Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks)
measure: Quality of Life assessment
timeFrame: Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks)
measure: Daytime Sleepiness
timeFrame: Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks)
measure: Sleep Quality
timeFrame: Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks)
measure: Physical activity assessment
timeFrame: Continuous midweek 72-hour monitoring at baseline, Continuous midweek 72-hour monitoring during week 7
measure: Physical activity and sleep assessment
timeFrame: Continuous midweek 72-hour monitoring at baseline, Continuous midweek 72-hour monitoring during week 7
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Our Lady's Hospice & Care Services
city: Dublin
country: Ireland
facility: St James's Hospital
Study officials:
References: