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
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 |
Verified date | June 2024 |
Source | University of Dublin, Trinity College |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Ireland | Our Lady's Hospice & Care Services | Dublin | |
Ireland | St James's Hospital | Dublin |
Lead Sponsor | Collaborator |
---|---|
University of Dublin, Trinity College |
Ireland,
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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