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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-modal intervention | Experimental | Single arm study receiving a multi-modal intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioural therapy for Insomnia (CBT-I) | Behavioral | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Our Lady's Hospice & Care Services | Dublin | D6W RY72 | Ireland | |||
| St James's Hospital |
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| Bright Light Therapy | Device | Daily bright light therapy for 30 minutes on waking delivered using the Lumie-L light box during an 8-week feasibility trial. |
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| Individualised activity plan | Behavioral | 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. |
|
| Clincial review | Other | 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 |
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| 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 |
| Dublin |
| D6W RY72 |
| Ireland |
| ID | Term |
|---|---|
| D021081 | Chronobiology Disorders |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D014467 | Ultraviolet Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D010789 | Phototherapy |
| D013812 | Therapeutics |
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