Trials / Completed
CompletedNCT06329479
A Feasibility Trial for Circadian Rest-activity Rhythm Disorders in Cancer (RALI)
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- University of Dublin, Trinity College · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-06-01
- Primary completion
- 2024-06-01
- Completion
- 2024-08-26
- First posted
- 2024-03-26
- Last updated
- 2025-04-03
Locations
2 sites across 1 country: Ireland
Source: ClinicalTrials.gov record NCT06329479. Inclusion in this directory is not an endorsement.