Chrono-behavioral Therapy for Chronic Fatigue in Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2027-11-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Chronic Fatigue Cancer Survivors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

The researcher in charge of the randomization is masked.

Study Groups

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Condition A: light/dark, eating and activity

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.

Group Type EXPERIMENTAL

Chronotherapy

Intervention Type 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.

Condition B: Light/dark and eating

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.

Group Type EXPERIMENTAL

Chronotherapy

Intervention Type 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.

Condition C: Light/dark and activity

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.

Group Type EXPERIMENTAL

Chronotherapy

Intervention Type 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.

Condition D: Eating and activity

Condition D: Eating and activity:

Eating within a 10-hour window and taking a 15 minutes daily walk.

Group Type EXPERIMENTAL

Chronotherapy

Intervention Type 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.

Condition E: Light/dark

Condition E: Light/dark:

Bright white light glasses 30 minutes upon awakening and blue light blocking glasses 3 hours before bedtime

Group Type EXPERIMENTAL

Chronotherapy

Intervention Type 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.

Condition F: Eating

Condition F: Eating:

Eating within a 10-hour window

Group Type EXPERIMENTAL

Chronotherapy

Intervention Type 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.

Condition G: Activity

Condition G: Activity:

Taking a15 minutes daily walk.

Group Type EXPERIMENTAL

Chronotherapy

Intervention Type 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.

Condition H: Circadian watch

Condition H: Circadian watch:

Waring a circadian watch to access circadian activity

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

Control condition

Interventions

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Chronotherapy

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.

Intervention Type BEHAVIORAL

Control

Control condition

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No