Circadian Rhythm DisordersNCT06329479
A Feasibility Trial for Circadian Rest-activity Rhythm Disorders in Cancer (RALI)
A study testing Cognitive behavioural therapy for Insomnia (CBT-I), Bright Light Therapy and Individualised activity plan in people with Circadian Rhythm Disorders and Cancer, run by University of Dublin, Trinity College at 2 sites in Ireland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Circadian Rhythm Disorders, Cancer
- What is being tested?
- Cognitive behavioural therapy for Insomnia (CBT-I), Bright Light Therapy and Individualised activity plan
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesIreland
- Study dates
- 1 Jun 2023to 26 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old
- Outpatient
- Diagnosis of advanced cancer (locally advanced, incurable, metastatic)
- Ambulatory
- Estimated prognosis ≥ 3 months
- Evidence of a circadian rest-activity rhythm disorder
Who cannot join
- Inpatient
- Engaged in shift-work
- Long-haul travel in the last 14 days
- Physical impairment limiting movement of the non-dominant arm
- Cognitive impairment limiting the ability to complete the assessment tool and/or patient diary
- Uncontrolled high blood pressure or tachycardia
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- Exercise-related symptoms and signs (e.g. chest pain, syncope, limb claudication, hypoxia at rest)
- Participant has a history of uncontrolled mania or bipolar disorder
- Participant has a recent history or current thoughts of self-harm or suicide
- Participant has a recent change in antidepressant medication
- Participant has an eye disorder (e.g. glaucoma, cataracts, retinopathy)
Trial locations and contacts
2 sites in 1 country.
Ireland2 sites
Our Lady's Hospice & Care Services
Dublin, D6W RY72
St James's Hospital
Dublin, D6W RY72
About this study
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
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
- Circadian Rhythm Disorders, Cancer
- Being tested
- Cognitive behavioural therapy for Insomnia (CBT-I), Bright Light Therapy, Individualised activity plan, Clincial review
- Keywords
- circadian rest-activity rhythms, advanced cancer, feasibility trial, multi-modal
- Medical subject headings
- Chronobiology Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioural therapy for Insomnia (CBT-I)Behavioural
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.
Bright Light TherapyDevice
Daily bright light therapy for 30 minutes on waking delivered using the Lumie-L light box during an 8-week feasibility trial.
Individualised activity planBehavioural
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 reviewOther
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
| Study group | Role | What they receive |
|---|---|---|
| Multi-modal intervention | Experimental | Single arm study receiving a multi-modal intervention Receives: Behavioral: Cognitive behavioural therapy for Insomnia (CBT-I); Device: Bright Light Therapy; Behavioral: Individualised activity plan; Other: Clincial review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability and usability of a multi-modal non-pharmacological intervention
Patient completed questionnaire of the acceptability and usability of interventions and research assessments
Measured: At the end of 8-weeks
Adherence to interventions
Patient completed weekly diary of adherence to the interventions and weekly monitoring by the researcher
Measured: 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)
Measured: Outcome assessed weekly during an 8-week trial
Completion rates of research assessments
Number of participants completing the midpoint and end of study assessments
Measured: 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
Measured: 1 year
Secondary outcomes (6)
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
Measured: Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks)
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).
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Continuous midweek 72-hour monitoring at baseline, Continuous midweek 72-hour monitoring during week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 Jun 2023
- Primary completion1 Jun 2024
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian Rhythm DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Andrew Davies, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329479
- Sponsor's protocol ID
- 1926B
- Status last verified
- Mar 2025
- First submitted
- 2 Nov 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06329479
- Acronym / sponsor ID
- 1926B
- Conditions
- Circadian Rhythm Disorders, Cancer
- Keywords
- circadian rest-activity rhythms, advanced cancer, feasibility trial, multi-modal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multi-modal intervention | Experimental | Behavioral: Cognitive behavioural therapy for Insomnia (CBT-I), Device: Bright Light Therapy, Behavioral: Individualised activity plan, Other: Clincial reviewSingle arm study receiving a multi-modal intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years old
- Outpatient
- Diagnosis of advanced cancer (locally advanced, incurable, metastatic)
- Ambulatory
- Estimated prognosis ≥ 3 months
Key exclusion criteria (11 listed)
- Inpatient
- Engaged in shift-work
- Long-haul travel in the last 14 days
- Physical impairment limiting movement of the non-dominant arm
- Cognitive impairment limiting the ability to complete the assessment tool and/or patient diary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Multi-modal intervention |
| Bright Light TherapyDaily bright light therapy for 30 minutes on waking delivered using the Lumie-L light box during an 8-week feasibility trial. | Device | Multi-modal intervention |
| Individualised activity planAn 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. | Behavioural | Multi-modal intervention |
| Clincial reviewTwo 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 | Other | Multi-modal intervention |
Primary outcome
Acceptability and usability of a multi-modal non-pharmacological intervention
Time frame: At the end of 8-weeks
Patient completed questionnaire of the acceptability and usability of interventions and research assessments
Adherence to interventions
Time frame: Outcome assessed weekly during the 8-week trial
Patient completed weekly diary of adherence to the interventions and weekly monitoring by the researcher
Adverse events
Time frame: Outcome assessed weekly during an 8-week trial
Number of subjects develop adverse events during the trial in accordance with the Common Terminology Criteria for Adverse Events (CTCAE)
Completion rates of research assessments
Time frame: Completed at baseline, week 2, week 4 and week 8
Number of participants completing the midpoint and end of study assessments
Recruitment rate
Time frame: 1 year
Number of participants recruited to the feasibility study over a 1 year period
6 secondary outcomes
Symptom assessment
Time frame: Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks)
Quality of Life assessment
Time frame: Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks)
Daytime Sleepiness
Time frame: Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks)
Sleep Quality
Time frame: Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks)
Physical activity assessment
Time frame: Continuous midweek 72-hour monitoring at baseline, Continuous midweek 72-hour monitoring during week 7
Physical activity and sleep assessment
Time frame: Continuous midweek 72-hour monitoring at baseline, Continuous midweek 72-hour monitoring during week 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioural therapy for Insomnia (CBT-I), Bright Light Therapy and Individualised activity plan in people with Circadian Rhythm Disorders and Cancer, run by University of Dublin, Trinity College at 2 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability and usability of a multi-modal non-pharmacological intervention (time frame: At the end of 8-weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.