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

NCT06931132 | Enrolling By Invitation DMC

• 1 other identifier: S00855-NIM
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 2

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

Keywords

Fatigue; Forest therapie; Virtual Reality

Outcome Measures

Primary Outcomes (4)

• Fatigue

  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).

  8 weeks (end of intervention)

• Sleep

  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).

  8 weeks (end of intervention)

• Depression

  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).

  8 weeks (end of intervention)

• Concentration

  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).

  8 weeks (end of intervention)

Secondary Outcomes (16)

• Fatigue

  8 weeks (end of intervention)

• Sleep

  8 weeks (end of intervention)

• Depression

  8 weeks (end of intervention)

• Concentration

  8 weeks (End of intervention)

• Resilience

  8 weeks (end of intervention)

Study Arms (4)

Real-life FOREST bathing

EXPERIMENTAL

Other: Real-life forest bathing

Simulated FOREST bathing (Virtual Reality).

EXPERIMENTAL

Other: Simulated FOREST bathing (Virtual Reality)

Imaging FOREST bathing.

EXPERIMENTAL

Other: Imaging FOREST bathing

Wait-list group

NO INTERVENTION

Interventions

Real-life forest bathing 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.

Real-life FOREST bathing

Simulated FOREST bathing (Virtual Reality) 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.

Simulated FOREST bathing (Virtual Reality).

Imaging FOREST bathing 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.

Imaging FOREST bathing.

Eligibility Criteria

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

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF): lead
• Wuerzburg University Hospital: collaborator
• University Hospital Tuebingen: collaborator

Study Sites (2)

Dr med. Marcela Winkler

Stuttgart, Baden-Wurttemberg, 70439, Germany

Location

PD Dr. Claudia Löffler

Würzburg, Bavaria, 97080, Germany

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Claudia Loeffler, Dr.

  Würzburg University. Würzburg, Bayern, Germany, 97080

  PRINCIPAL INVESTIGATOR

• Marcela Winkler, Dr.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Integrative Medicine

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 17, 2025
• Study Start: June 5, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-04

Locations

DE (2)