Chrono-behavioral Therapy for Chronic Fatigue in Cancer

NCT06845267 | Not Yet Recruiting

• 1 other identifier: ChronoBT
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Fatigue; Cancer Survivors

Outcome Measures

Primary Outcomes (1)

• Cancer-related Fatigue

  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.

  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 (9)

• Sleep Quality

  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

  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

  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

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

• Cognition

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

Other Outcomes (1)

• Adherence and fidelity

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

Study Arms (8)

Condition A: light/dark, eating and activity

EXPERIMENTAL

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.

Behavioral: Chronotherapy

Condition B: Light/dark and eating

EXPERIMENTAL

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.

Behavioral: Chronotherapy

Condition C: Light/dark and activity

EXPERIMENTAL

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.

Behavioral: Chronotherapy

Condition D: Eating and activity

EXPERIMENTAL

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

Behavioral: Chronotherapy

Condition E: Light/dark

EXPERIMENTAL

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

Behavioral: Chronotherapy

Condition F: Eating

EXPERIMENTAL

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

Behavioral: Chronotherapy

Condition G: Activity

EXPERIMENTAL

Condition G: Activity: Taking a15 minutes daily walk.

Behavioral: Chronotherapy

Condition H: Circadian watch

ACTIVE COMPARATOR

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

Behavioral: Control

Interventions

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.

Condition A: light/dark, eating and activity; Condition B: Light/dark and eating; Condition C: Light/dark and activity; Condition D: Eating and activity; Condition E: Light/dark; Condition F: Eating; Condition G: Activity

Control BEHAVIORAL

Control condition

Condition H: Circadian watch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead
• University of Aarhus: collaborator

Study Sites (1)

Aarhus University and Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Interventions

Chronotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Lisa M Wu, PhD

  University of Aarhus

  PRINCIPAL INVESTIGATOR

• Ali Amidi, PhD

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa M Wu, PhD

CONTACT

+45 87153748; lisa.wu@psy.au.dk

Louise Strøm, PhD

CONTACT

+45 87165076; louisestroem@oncology.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The researcher in charge of the randomization is masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 25, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

DK (1)