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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Circadian Rhythm Disorders
• Intervention / Treatment: Behavioral: Cognitive behavioural therapy for Insomnia (CBT-I); Device: Bright Light Therapy; Behavioral: Individualised activity plan; Other: Clincial review

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, D6W RY72
    • Recruiting
    • Our Lady's Hospice & Care Services
    • Contact: Craig Gouldthorpe; Phone Number: +3534986235; Email: gouldthc@tcd.ie
  • Dublin, Ireland, D6W RY72
    • Recruiting
    • St James's Hospital
    • Contact: Craig Gouldthorpe; Phone Number: +3534986235; Email: gouldthc@tcd.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Multi-modal intervention; Single arm study receiving a multi-modal intervention

Behavioral: Cognitive behavioural therapy for Insomnia (CBT-I); 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.; Device: Bright Light Therapy; Daily bright light therapy for 30 minutes on waking delivered using the Lumie-L light box during an 8-week feasibility trial.; Behavioral: Individualised activity plan; 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.; Other: Clincial review; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom assessment	Memorial Symptom Assessment Score Short Form (MSAS-SF). The scale assesses the presence and level of distress (Not at all, A little bit, Somewhat, Quite a bit, Very much) associated with 32 physical and psychological symptoms. Higher scores suggest increased symptomatology and increased distress	Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks)
Quality of Life assessment	European Organisation for Research and Treatment of Cancer QLQ-C30. Participants rate 28 symptom and quality of life measures on a scale (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much). Higher scores suggest a worser outcome. Participants also rate their overall health and quality of life on a scale 1-7 (1 = very poor, 7 = excellent).	Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks)
Daytime Sleepiness	Epworth Sleepiness Scale. Participants rate the likelihood of falling asleep in 8 scenarios. Higher scores suggest increased daytime sleepiness	Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks)
Sleep Quality	Brief Pittsburgh Sleep Quality Index (bPSQI). Participants complete 6 questions with higher scores suggesting poorer sleep quality.	Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks)
Physical activity assessment	Physical activity will be captured over a continuous 72-hour period using wrist and thigh accelerometry. Accelerometry devices collect activity counts during 1 minute periods (epochs).	Continuous midweek 72-hour monitoring at baseline, Continuous midweek 72-hour monitoring during week 7
Physical activity and sleep assessment	A novel diary will be completed. Daytime physical activity will be assessed (level of tiredness, level of exertion, time spent during different activity intensities). Additional medication, smoking, caffeine and alcohol use will be documented. Nighttime sleep will also be assessed (time in bed, time to lights off, time to fall asleep, waking time, out of bed time, sleep quality).	Continuous midweek 72-hour monitoring at baseline, Continuous midweek 72-hour monitoring during week 7

Collaborators and Investigators

• Sponsor: University of Dublin, Trinity College

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: November 2, 2023
• First Submitted That Met QC Criteria: March 23, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 23, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: advanced cancer; feasibility trial; circadian rest-activity rhythms; multi-modal
• Additional Relevant MeSH Terms: Nervous System Diseases; Chronobiology Disorders
• Other Study ID Numbers: 1926B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No