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Trial Title:
A Feasibility Trial for Circadian Rest-activity Rhythm Disorders in Cancer (RALI)
NCT ID:
NCT06329479
Condition:
Circadian Rhythm Disorders
Cancer
Conditions: Official terms:
Chronobiology Disorders
Conditions: Keywords:
circadian rest-activity rhythms
advanced cancer
feasibility trial
multi-modal
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Cognitive behavioural therapy for Insomnia (CBT-I)
Description:
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.
Arm group label:
Multi-modal intervention
Intervention type:
Device
Intervention name:
Bright Light Therapy
Description:
Daily bright light therapy for 30 minutes on waking delivered using the Lumie-L light box
during an 8-week feasibility trial.
Arm group label:
Multi-modal intervention
Intervention type:
Behavioral
Intervention name:
Individualised activity plan
Description:
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.
Arm group label:
Multi-modal intervention
Intervention type:
Other
Intervention name:
Clincial review
Description:
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
Arm group label:
Multi-modal intervention
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.
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Our Lady's Hospice & Care Services
Address:
City:
Dublin
Zip:
D6W RY72
Country:
Ireland
Status:
Recruiting
Contact:
Last name:
Craig Gouldthorpe
Phone:
+3534986235
Email:
gouldthc@tcd.ie
Facility:
Name:
St James's Hospital
Address:
City:
Dublin
Zip:
D6W RY72
Country:
Ireland
Status:
Recruiting
Contact:
Last name:
Craig Gouldthorpe
Phone:
+3534986235
Email:
gouldthc@tcd.ie
Start date:
June 1, 2023
Completion date:
September 1, 2024
Lead sponsor:
Agency:
University of Dublin, Trinity College
Agency class:
Other
Source:
University of Dublin, Trinity College
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06329479
