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

NCT06329479 | Completed

• 1 other identifier: 1926B
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Circadian Rhythm Disorders; Cancer

Keywords

circadian rest-activity rhythms; advanced cancer; feasibility trial; multi-modal

Outcome Measures

Primary Outcomes (5)

• Acceptability and usability of a multi-modal non-pharmacological intervention

  Patient completed questionnaire of the acceptability and usability of interventions and research assessments

  At the end of 8-weeks

• Adherence to interventions

  Patient completed weekly diary of adherence to the interventions and weekly monitoring by the researcher

  Outcome assessed weekly during the 8-week trial

• Adverse events

  Number of subjects develop adverse events during the trial in accordance with the Common Terminology Criteria for Adverse Events (CTCAE)

  Outcome assessed weekly during an 8-week trial

• Completion rates of research assessments

  Number of participants completing the midpoint and end of study assessments

  Completed at baseline, week 2, week 4 and week 8

• Recruitment rate

  Number of participants recruited to the feasibility study over a 1 year period

  1 year

Secondary Outcomes (6)

• Symptom assessment

  Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks)

• Quality of Life assessment

  Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks)

• Daytime Sleepiness

  Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks)

• Sleep Quality

  Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks)

• Physical activity assessment

  Continuous midweek 72-hour monitoring at baseline, Continuous midweek 72-hour monitoring during week 7

Study Arms (1)

Multi-modal intervention

EXPERIMENTAL

Single arm study receiving a multi-modal intervention

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

Interventions

Cognitive behavioural therapy for Insomnia (CBT-I) BEHAVIORAL

A psychoeducational and evidence-based skills and strategies course for insomnia delivered online over four lessons through ThisWayUp. This will be completed during an 8-week feasibility trial.

Multi-modal intervention

Bright Light Therapy DEVICE

Daily bright light therapy for 30 minutes on waking delivered using the Lumie-L light box during an 8-week feasibility trial.

Multi-modal intervention

Individualised activity plan BEHAVIORAL

An individualised activity plan is created at baseline and adjusted weekly aiming to increased daytime physical activity and reduce sedentary behaviours. The activity plan takes into consideration personal interests, perceived barriers to activity and develops an activity plan using Specific Measureable Achievable Realistic and Timely (SMART) goals. This will take place during an 8-week feasibility trial.

Multi-modal intervention

Clincial review OTHER

Two clinical reviews will take place during an 8-week feasibility trial and consider uncontrolled symptoms, medication and blood test abnormalities which may impact on rest and physical activity levels

Multi-modal intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inpatient
• Engaged in shift-work
• Long-haul travel in the last 14 days
• Physical impairment limiting movement of the non-dominant arm
• Cognitive impairment limiting the ability to complete the assessment tool and/or patient diary
• Uncontrolled high blood pressure or tachycardia
• Exercise-related symptoms and signs (e.g. chest pain, syncope, limb claudication, hypoxia at rest)
• Participant has a history of uncontrolled mania or bipolar disorder
• Participant has a recent history or current thoughts of self-harm or suicide
• Participant has a recent change in antidepressant medication
• Participant has an eye disorder (e.g. glaucoma, cataracts, retinopathy)

Sponsors & Collaborators

• University of Dublin, Trinity College: lead

Study Sites (2)

Our Lady's Hospice & Care Services

Dublin, D6W RY72, Ireland

Location

St James's Hospital

Dublin, D6W RY72, Ireland

Location

MeSH Terms

Conditions

Chronobiology Disorders; Neoplasms

Interventions

Cognitive Behavioral Therapy; Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Nervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Phototherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Palliative Medicine

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: March 26, 2024
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: August 26, 2024
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

IE (2)