A Feasibility Trial for Circadian Rest-activity Rhythm Disorders in Cancer (RALI)

March 31, 2025 updated by: Prof Andrew Davies, University of Dublin, Trinity College

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland, D6W RY72
        • Our Lady's Hospice & Care Services
      • Dublin, Ireland, D6W RY72
        • St James's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Multi-modal intervention
Single arm study receiving a multi-modal intervention
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
At the end of 8-weeks
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
Outcome assessed weekly during the 8-week trial
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)
Outcome assessed weekly during an 8-week trial
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
Completed at baseline, week 2, week 4 and week 8
Recruitment rate
Time Frame: 1 year
Number of participants recruited to the feasibility study over a 1 year period
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Symptom assessment
Time Frame: Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks)
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)
Quality of Life assessment
Time Frame: Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks)
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
Time Frame: Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks)
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
Time Frame: Time 1 (baseline), Time 2 (end of 4 weeks), Time 3 (end of 8 weeks)
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
Time Frame: Continuous midweek 72-hour monitoring at baseline, Continuous midweek 72-hour monitoring during week 7
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
Time Frame: Continuous midweek 72-hour monitoring at baseline, Continuous midweek 72-hour monitoring during week 7
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Dublin, Trinity College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1926B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings