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

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.

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)