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

NCT ID: NCT06931132

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-05
• Study Completion Date: 2027-12-31

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.

Conditions

Cancer Survivors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Real-life FOREST bathing

Group Type: EXPERIMENTAL

Real-life forest bathing

Intervention Type: OTHER

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).

Group Type: EXPERIMENTAL

Simulated FOREST bathing (Virtual Reality)

Intervention Type: OTHER

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.

Group Type: EXPERIMENTAL

Imaging FOREST bathing

Intervention Type: OTHER

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.

Wait-list group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wuerzburg University Hospital

OTHER

Sponsor Role: collaborator

University Hospital Tuebingen

OTHER

Sponsor Role: collaborator

Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

OTHER

Sponsor Role: lead

Responsible Party

Marcela Winkler, MD

Head of Integrative Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia Loeffler, Dr.

Role: PRINCIPAL_INVESTIGATOR

Würzburg University. Würzburg, Bayern, Germany, 97080

Marcela Winkler, Dr.

Role: PRINCIPAL_INVESTIGATOR

Robert-Bosch-Krankenhaus, Stuttgart, Baden Würtemberg, Germany, 70341

Locations

Dr med. Marcela Winkler

Stuttgart, Baden-Wurttemberg, Germany

PD Dr. Claudia Löffler

Würzburg, Bavaria, Germany

Countries

Germany

Other Identifiers

S00855-NIM

Identifier Type: -

Identifier Source: org_study_id