Chrono-behavioral Therapy for Chronic Fatigue in Cancer (ChronoBT)

Aarhus University Hospital

Status: Not yet enrolling

Conditions: Chronic Fatigue; Cancer Survivors

Treatments: Behavioral: Chronotherapy; Behavioral: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT06845267

ChronoBT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 8 patient groups

Condition A: light/dark, eating and activity

Experimental group

Description:

Condition A: light/dark, eating and activity: Bright white light glasses 30 minutes upon awakening and blue light blocking glasses 3 hours before bedtime; eating within a 10-hour window, and taking a 15 minutes daily walk.

Treatment:

Behavioral: Chronotherapy

Condition B: Light/dark and eating

Experimental group

Description:

Condition B: Light/dark and eating: Bright white light glasses 30 minutes upon awakening and blue light blocking glasses 3 hours before bedtime and eating within a 10-hour window.

Treatment:

Behavioral: Chronotherapy

Condition C: Light/dark and activity

Experimental group

Description:

Condition C: Light/dark and activity: Bright white light glasses 30 minutes upon awakening and blue light blocking glasses 3 hours before bedtime and taking a 15 minutes daily walk.

Treatment:

Behavioral: Chronotherapy

Condition D: Eating and activity

Experimental group

Description:

Condition D: Eating and activity: Eating within a 10-hour window and taking a 15 minutes daily walk.

Treatment:

Behavioral: Chronotherapy

Condition E: Light/dark

Experimental group

Description:

Condition E: Light/dark: Bright white light glasses 30 minutes upon awakening and blue light blocking glasses 3 hours before bedtime

Treatment:

Behavioral: Chronotherapy

Condition F: Eating

Experimental group

Description:

Condition F: Eating: Eating within a 10-hour window

Treatment:

Behavioral: Chronotherapy

Condition G: Activity

Experimental group

Description:

Condition G: Activity: Taking a15 minutes daily walk.

Treatment:

Behavioral: Chronotherapy

Condition H: Circadian watch

Active Comparator group

Description:

Condition H: Circadian watch: Waring a circadian watch to access circadian activity

Treatment:

Behavioral: Control