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NCT Number: NCT06845267

Chrono-behavioral Therapy for Chronic Fatigue in Cancer

Cancer-related fatigue (CRF) is a severe and persistent side effect of cancer and its treatment, affecting up to 40% of patients and significantly reducing quality of life. Recent research suggests that circadian rhythm disruption has been implicated as a possible related pathophysiological mechanism underlying CRF. Circadian rhythms are 24-hour cycles regulating physiology and behavior through environmental cues called "zeitgebers." Strengthening these cues-such as light exposure, physical activity, and eating-may help reduce CRF.

This project will develop and test the optimal combination a home-based, low-burden chrono-behavioral therapy (ChronoBT) targeting these zeitgebers.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Cancer-related fatigue (CRF) is frequently reported as the most severe and distressing side effect of cancer and its treatment. Among cancer patients, up to 40% will experience CRF that can last months or even years after treatment and it is also deleterious to quality of life. However, there is still no established CRF treatment. Underlying mechanisms of CRF are likely multi-factorial and recently, circadian rhythm disruption has been implicated as a possible related pathophysiological mechanism underlying CRF. Circadian rhythms are endogenous 24-hour cycles of rhythmicity in physiology and behavior orchestrated by the suprachiasmatic nuclei (SCN) in the brain. They are entrained to the environment via time-giving cues called "zeitgebers". Thus, improving circadian rhythm robustness by strengthening modifiable zeitgebers is one potential way to ameliorate CRF. The overarching goal of the proposed project is to conduct an optimization trial of a home-based, low-burden multicomponent chrono-behavioral therapy (ChronoBT) that aims to strengthen the effects of 3 zeitgebers to treat CRF - light/dark exposure, physical activity and eating - all of which individually have shown promise in strengthening circadian rhythms and reducing fatigue. The study will include two work packages: In Work Package 1 (WP1), the investigators will pilot test candidate intervention components in prostate and female breast cancer survivors. In Work Package 2 (WP2), a fully powered optimization trial will be undertaken using the framework - the Multiphase Optimization Strategy (MOST), to test the optimal combination of ChronoBT components.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • prostate or female breast cancer survivors
  • completed local and/or adjuvant cancer therapy (with the exception of hormonal therapy) ≥ 1 year previously
  • ≥18 years of age
  • able to speak and read Danish
  • experiencing CRF (score ≤36 on FACT-F)

Exclusion criteria

  • use of light therapy in the last year
  • confounding underlying medical/psychiatric disorders or use of medications associated with fatigue (e.g., a central nervous system cancer, untreated hypothyroidism, anemia, chronic fatigue syndrome, insomnia, major depression)
  • non-cancer related factor likely to be a driver of fatigue (e.g., shift work, pregnancy, recent travel across time zones)
  • recurrence of cancer or new cancer
  • physical or psychological conditions that could prevent participation in intervention components
  • use of photosensitizing medications

Treatment and study plan

Chronotherapy

Behavioral

This study utilize and test different combinations of three types of interventions (zeitgebers) to entrain the circadian rhythm: 1) Light being the primary photic zeitgebers that directly entrain the SCN, 2) physical activity and 3) timing of eating) being non-photic zeitgebers that drive peripheral rhythms.

Control

Behavioral

Control condition

Primary outcomes

  1. Cancer-related Fatigue

    Time frame: T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)

    Cancer-related Fatigue by the Functional Assessment of Cancer Therapy - Fatigue Scale (FACT-F) Number of items: 13. Score range: 0-52. Lower score indicates more fatigue.

Secondary outcomes

  1. Sleep Quality

    Time frame: T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)

    Sleep quality by the Pittsburg Sleep Quality Index (PSQI), measuring seven domains. Higher score indicates worse sleep.

  2. Insomnia

    Time frame: T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)

    Insomnia by the Insomnia Severity Index (ISI). Number of items: 7. Score range: 0-28. Higher score indicate worse insomnia.

  3. Anxiety and Depression

    Time frame: T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)

    Anxiety and Depression by the Hospital Anxiety and Depression Scale (HADS). Number of items: 14. Score range: 0-21 for each domain. Higher score indicates worse symptoms.

  4. Health-related Quality of Life

    Time frame: T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)

    Health-related Quality of Life by the Functional Assessment of Cancer Therapy - General (FACT-G). Number of items: 27. Score range: 0-128. Higher score indicates worse quality of life.

  5. Cognition

    Time frame: T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)

    Quality of Life - Cognition items from the European Organization for Research and Treatment of Cancer Questionnaires (EORTC-QLQ-30). Number of items: 2. Score range: 2-8. Higher score indicate more impairment.

  6. Circadian Function

    Time frame: During the entire period of intervention and follow-up T4 (4 weeks post intervention completion)

    Circadian Function Index derived from actigraphy data. Score range: 0-1. Higher score indicate more robust rhythms.

  7. Chronotype

    Time frame: T1 (Baseline)

    Chronotype by the reduced Morningness-Eveningness Questionnaire (rMEQ). Number of items: 5. Score range 5-25. Higher score indicates closer to morningness type, while lower score indicate closer to eveningness type.

  8. Credibility/Expectancy

    Time frame: T1 (Baseline)

    Credibility/Expectancy by the Credibility/Expectancy Questionnaire (CEQ). Number of items: 6. Item score range: 1-9. Higher score indicates more credibility/expectancy.

  9. Treatment Satisfaction

    Time frame: T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)

    Treatment Satisfaction by the Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General (FACIT-TS-G).

    Number of items: 8. Score range: 0-21. Higher score indicates better satisfaction.

Other outcomes

  1. Adherence and fidelity

    Time frame: During the intervention period: One week for WP1, and four weeks for WP2

    Start/end times of component(s) and protocol deviations by personal logs

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa M Wu, PhD

CONTACT

[email protected]

+45 87153748

Louise Strøm, PhD

CONTACT

[email protected]

+45 87165076

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • University of Aarhus

Registry information

Acronym: ChronoBT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 25, 2025
Registry last updated
Mar 14, 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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