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Completed

NCT Number: NCT06329479

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

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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Key information

Conditions

Circadian Rhythm Disorders Cancer Chronobiology Disorders Neoplasms Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Our Lady's Hospice & Care Services, Dublin, Ireland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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)

Treatment and study plan

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.

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.

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

Primary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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

  5. Recruitment rate

    Time frame: 1 year

    Number of participants recruited to the feasibility study over a 1 year period

Secondary outcomes

  1. 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

  2. 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).

  3. 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

  4. 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.

  5. 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).

  6. 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).

Sponsors and collaborators

Lead sponsor

University of Dublin, Trinity College

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 26, 2024
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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