Clinical trial NCT06931132: Cancer-related Fatigue and Symptom Clusters - Effects of Virtual, Imagined and Real-life Nature-based Therapy in Cancer Survivors
Official title: Cancer-related Fatigue and Symptom Clusters - Effects of Virtual, Imagined and Real-life Nature-based Therapy in Cancer Survivors - a RCT
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer Survivors
Keywords: Fatigue
Forest therapie
Virtual Reality
Lead sponsor: Robert Bosch Gesellschaft für Medizinische Forschung mbH
Sponsor class: OTHER
Collaborators: name: Wuerzburg University Hospital
name: University Hospital Tuebingen
First posted: 2025-04-17
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 criteria: 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 outcomes:
measure: Fatigue
timeFrame: 8 weeks (end of intervention)
measure: Sleep
timeFrame: 8 weeks (end of intervention)
measure: Depression
timeFrame: 8 weeks (end of intervention)
measure: Concentration
timeFrame: 8 weeks (end of intervention)
Secondary outcomes:
measure: Fatigue
timeFrame: 8 weeks (end of intervention)
measure: Sleep
timeFrame: 8 weeks (end of intervention)
measure: Depression
timeFrame: 8 weeks (end of intervention)
measure: Concentration
timeFrame: 8 weeks (End of intervention)
measure: Resilience
timeFrame: 8 weeks (end of intervention)
measure: Mindfulness
timeFrame: 8 weeks (end of intervention)
measure: Anxiety
timeFrame: 8 weeks (end of intervention)
measure: Quality of life Questionnaire
timeFrame: 8 weeks (end of intervention)
measure: Sensation of stress
timeFrame: 8 weeks (end of intervention)
measure: Simulator Disease (Virtual reality group only, arm 2)
timeFrame: 8 weeks (end of intervention)
measure: Physical Activity and Sport Questionnaire
timeFrame: 8 weeks (end of intervention)
measure: Safety evaluation
timeFrame: Through 8 weeks of intervention (Weeks 0-8)
measure: Average daily step count (measured via wearable activity tracker)
timeFrame: Cumulative average daily steps over Weeks 1-8
measure: Heart rate variability
timeFrame: 8 weeks (end of intervention)
measure: Natural killer cell activity
timeFrame: 8 weeks (end of intervention)
measure: Serum cytokine concentrations (IL-6, IL-10, TNF-alpha)
timeFrame: Week 4 (Mid-intervention), Week 8 (End of intervention)
Other outcomes:
Locations:
Study officials:
affiliation: Würzburg University. Würzburg, Bayern, Germany, 97080
name: Claudia Loeffler, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Robert-Bosch-Krankenhaus, Stuttgart, Baden Würtemberg, Germany, 70341
name: Marcela Winkler, Dr.
role: PRINCIPAL_INVESTIGATOR
References: