Clinical trial NCT06845267: Chrono-behavioral Therapy for Chronic Fatigue in Cancer
Official title: Chrono-behavioral Therapy for Chronic Fatigue in Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Fatigue
Cancer Survivors
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2025-02-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible participants will be randomly assigned to one of eight 4-week intervention conditions to test the optimal combination of the three ChronoBT components utilizing a Multiphase Optimization Strategy (MOST).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. prostate or female breast cancer survivors
2. completed local and/or adjuvant cancer therapy (with the exception of hormonal therapy) ≥ 1 year previously
3. ≥18 years of age
4. able to speak and read Danish
5. experiencing CRF (score ≤36 on FACT-F)

Exclusion Criteria:

1. use of light therapy in the last year
2. 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)
3. non-cancer related factor likely to be a driver of fatigue (e.g., shift work, pregnancy, recent travel across time zones)
4. recurrence of cancer or new cancer
5. physical or psychological conditions that could prevent participation in intervention components
6. use of photosensitizing medications

Primary outcomes:
measure: Cancer-related Fatigue
timeFrame: T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)
Secondary outcomes:
measure: Sleep Quality
timeFrame: T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)
measure: Insomnia
timeFrame: T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)
measure: Anxiety and Depression
timeFrame: T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)
measure: Health-related Quality of Life
timeFrame: T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)
measure: Cognition
timeFrame: T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)
measure: Circadian Function
timeFrame: During the entire period of intervention and follow-up T4 (4 weeks post intervention completion)
measure: Chronotype
timeFrame: T1 (Baseline)
measure: Credibility/Expectancy
timeFrame: T1 (Baseline)
measure: Treatment Satisfaction
timeFrame: T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)
Other outcomes:
measure: Adherence and fidelity
timeFrame: During the intervention period: One week for WP1, and four weeks for WP2
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University and Aarhus University Hospital
Study officials:
affiliation: University of Aarhus
name: Lisa M Wu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Aarhus
name: Ali Amidi, PhD
role: PRINCIPAL_INVESTIGATOR
References: