Ireland
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Enrolling by invitation Not applicable

Cancer-related Fatigue and Symptom Clusters - Effects of Virtual, Imagined and Real-life Nature-based Therapy in Cancer Survivors

NCT06931132 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2025-06-05
Last updated
2025-09-22

Condition(s) studied

Cancer Survivors

Investigational drug(s) / intervention(s)

Real-life forest bathingSimulated FOREST bathing (Virtual Reality)Imaging FOREST bathing

Real-life forest bathing: Participants will experience the elements (olfactory, acoustic and haptic) of forest bathing for 30 minutes (sitting) in a forested area. The forests have been previously selected near Stuttgart and Würzburg and are comparable to each other.

Simulated FOREST bathing (Virtual Reality): Using virtual reality goggles, a FOREST bathing experience will be simulated. The simulation will have elements of the classic FOREST bathing (olfatory, acoustic and haptic) and will last 30 minutes.

Imaging FOREST bathing: A therapist will lead an imaginative exercise in which participants will imagine a FOREST bathing. The imaginative exercise will include elements of the classic FOREST bathing (olfactory, acoustic and haptic) and will last 30 minutes.

Study summary

This is a randomized, controlled, bicenter trial comparing the effects on symptoms and quality of life in cancer survivors. Three nature-based therapies will be compared with a wait-list group. The therapies are: virtual reality simulated forest, guided imaging and classic forest bathing. Each intervention lasts 30 minutes and takes place once a week for 8 weeks. All interventions involve different stimulus types: visual, olfactory, auditory and tactile.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients who have completed treatment for cancer (\*with the exception of long-term adjuvant endocrine therapy). * Subjective Impairment due to Cancer-Related Fatigue (CrF) . NCCN-recommended questions are used for screening ("How exhausted do you feel on a scale of 0 to 10?" and "How impaired do you feel by this fatigue on a scale of 0 to 10?" (threshold \>4 on either scale). * At the time of study inclusion, it must be expected that no further antitumor therapy measures will be started within the next 6 months. * Patients must be able to refrain from smoking up to 15 minutes before the intervention (smoking within 15 minutes before therapy impairs the participant's ability to perceive the aroma of the phytoncides). * Written and valid informed consent from the patient. Exclusion Criteria: * Presence of inadequately controlled major depression in the opinion of the investigator. * Asthma (inhaled phytoncides may cause airway irritation, exacerbation of asthma, or bronchoconstriction). * Known allergy to pine or citrus fragrance. * Anosmie. * Medical history of seasickness (virtual reality can cause nausea/vomiting with no improvement after 5-10 minutes). * History of seizures (virtual reality may increase susceptibility to seizures due to the changing light in the forest video). * Visual and hearing impairments that are not corrected by visual or hearing aids. * Unwillingness to store and share personal medical data as part of the protocol. * Participation in another clinical trial focusing on behavioural or complementary medicine interventions. * Missing or incomplete consent form.

Primary outcome measure(s)

  • Fatigue — 8 weeks (end of intervention)
    The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a validated tool for the reliable measurement of fatigue in patients with cancer and other chronic diseases. The questionnaire has high internal consistency and validity and allows assessment of fatigue and its impact on quality of life and disease progression. 13 items to measure self-reported fatigue and its impact on daily activities and functions. Scores range from 0 to 52, with higher scores indicating less fatigue (better outcome).
  • Sleep — 8 weeks (end of intervention)
    The Pittsburgh Sleep Quality Index (PSQI) measures subjective sleep quality. The 19-item questionnaire generates seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime disturbances. The sum of the scores for these seven components gives a global score. Scores range from 0 to 21, with higher scores indicating poorer sleep quality (worse outcome).
  • Depression — 8 weeks (end of intervention)
    The Patient Health Questionnaire-9 (PHQ-9) is often used for the initial diagnosis of depression and for monitoring the course of the illness. The PHQ-9 consists of 9 questions that ask about the main and core symptoms of depression over the past two weeks, providing a structured and objective assessment of the severity of depression. Scores range from 0 to 27, with higher scores indicating more severe depression (worse outcome).
  • Concentration — 8 weeks (end of intervention)
    The Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) is a 5-point Likert scale measure of chemotherapy-induced cognitive impairment in cancer patients. The questionnaire consists of 24 items covering four different domains: self-perceived cognitive impairment, feedback from others, perceived cognitive ability, and impact on quality of life. The assessment of these cognitive aspects indicates a relationship with objective symptoms and allows for a nuanced assessment of treatment-induced cognitive impairment. Scores range from 0 to 148, with higher scores indicating better perceived cognitive functioning (better outcome).

Trial sites (2)

FacilityCityRegionStatus
Dr med. Marcela Winkler Stuttgart Baden-Wurttemberg
PD Dr. Claudia Löffler Würzburg Bavaria
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06931132 on ClinicalTrials.gov ↗ ← All trials in Germany