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

Not Applicable

Recruiting

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

• Registration Number: NCT06329479
• Lead Sponsor: University of Dublin, Trinity College

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-11-02
• Study First Submitted QC: 2024-03-23
• Study First Posted: 2024-03-26
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-17
• Primary Completion: 2024-07-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multi-modal intervention	Cognitive behavioural therapy for Insomnia (CBT-I)	Single arm study receiving a multi-modal intervention
Multi-modal intervention	Individualised activity plan	Single arm study receiving a multi-modal intervention
Multi-modal intervention	Clincial review	Single arm study receiving a multi-modal intervention
Multi-modal intervention	Bright Light Therapy	Single arm study receiving a multi-modal intervention

Primary Outcome Measures

Name	Time	Method
Adverse events	Outcome assessed weekly during an 8-week trial	Number of subjects develop adverse events during the trial in accordance with the Common Terminology Criteria for Adverse Events (CTCAE)
Acceptability and usability of a multi-modal non-pharmacological intervention	At the end of 8-weeks	Patient completed questionnaire of the acceptability and usability of interventions and research assessments
Completion rates of research assessments	Completed at baseline, week 2, week 4 and week 8	Number of participants completing the midpoint and end of study assessments
Adherence to interventions	Outcome assessed weekly during the 8-week trial	Patient completed weekly diary of adherence to the interventions and weekly monitoring by the researcher
Recruitment rate	1 year	Number of participants recruited to the feasibility study over a 1 year period

Secondary Outcome Measures

Name	Time	Method
Symptom assessment	Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks)	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
Physical activity assessment	Continuous midweek 72-hour monitoring at baseline, Continuous midweek 72-hour monitoring during week 7	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).
Daytime Sleepiness	Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks)	Epworth Sleepiness Scale. Participants rate the likelihood of falling asleep in 8 scenarios. Higher scores suggest increased daytime sleepiness
Physical activity and sleep assessment	Continuous midweek 72-hour monitoring at baseline, Continuous midweek 72-hour monitoring during week 7	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).
Quality of Life assessment	Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks)	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).
Sleep Quality	Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks)	Brief Pittsburgh Sleep Quality Index (bPSQI). Participants complete 6 questions with higher scores suggesting poorer sleep quality.

Trial Locations

Locations (2)

Our Lady's Hospice & Care Services; 🇮🇪 Dublin, Ireland

St James's Hospital; 🇮🇪 Dublin, Ireland