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

Last updated: March 31, 2025
Sponsor: University of Dublin, Trinity College
Overall Status: Completed

Phase

N/A

Condition

Cancer

Sleep Disorders

Treatment

Cognitive behavioural therapy for Insomnia (CBT-I)

Bright Light Therapy

Individualised activity plan

Clinical Study ID

NCT06329479
1926B
  • Ages > 18
  • All Genders

Study 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

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

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/orpatient 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)

Study Design

Total Participants: 30
Treatment Group(s): 4
Primary Treatment: Cognitive behavioural therapy for Insomnia (CBT-I)
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
August 26, 2024

Connect with a study center

  • Our Lady's Hospice & Care Services

    Dublin, D6W RY72
    Ireland

    Site Not Available

  • St James's Hospital

    Dublin, D6W RY72
    Ireland

    Site Not Available

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