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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06329479
• Other study ID #: 1926B
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: March 2024
• Source: University of Dublin, Trinity College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cancer
• Chronobiology Disorders
• Circadian Rhythm Disorders

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

Locations

Country	Name	City	State
Ireland	Our Lady's Hospice & Care Services	Dublin
Ireland	St James's Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
University of Dublin, Trinity College

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Recruitment rate	Number of participants recruited to the feasibility study over a 1 year period	1 year
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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