A Feasibility Trial for Circadian Rest-activity Rhythm Disorders in Cancer (RALI)

University of Dublin, Trinity College

Status: Completed

Conditions: Circadian Rhythm Disorders; Cancer

Treatments: Device: Bright Light Therapy; Behavioral: Cognitive behavioural therapy for Insomnia (CBT-I); Behavioral: Individualised activity plan; Other: Clincial review

Study type: Interventional

Funder types: Other

Identifiers

NCT06329479

1926B

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Multi-modal intervention

Experimental group

Description:

Single arm study receiving a multi-modal intervention

Treatment:

Other: Clincial review

Behavioral: Individualised activity plan

Behavioral: Cognitive behavioural therapy for Insomnia (CBT-I)

Device: Bright Light Therapy