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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06329479
Other study ID # 1926B
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date September 1, 2024

Study information

Verified date June 2024
Source University of Dublin, Trinity College
Contact n/a
Is FDA regulated No
Health authority
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 July 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)

Study Design


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
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