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

Robert Bosch Gesellschaft für Medizinische Forschung mbH

Status: Begins enrollment in 2 months

Conditions: Cancer Survivors

Treatments: Other: Simulated FOREST bathing (Virtual Reality); Other: Real-life forest bathing; Other: Imaging FOREST bathing

Study type: Interventional

Funder types: Other

Identifiers

NCT06931132

S00855-NIM

Details and patient eligibility

About

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.

Enrollment: 172 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

172 participants in 4 patient groups

Real-life FOREST bathing

Experimental group

Treatment:

Other: Real-life forest bathing

Simulated FOREST bathing (Virtual Reality).

Experimental group

Treatment:

Other: Simulated FOREST bathing (Virtual Reality)

Imaging FOREST bathing.

Experimental group

Treatment:

Other: Imaging FOREST bathing

Wait-list group

No Intervention group