Enrolling by invitation NCT06931132
Cancer-related Fatigue and Symptom Clusters - Effects of Virtual, Imagined and Real-life Nature-based Therapy in Cancer Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Real-life forest bathing, Simulated FOREST bathing (Virtual Reality), Imaging FOREST bathing.
- Who it may be relevant to
- Registry conditions: Cancer Survivors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cancer-related Fatigue and Symptom Clusters - Effects of Virtual, Imagined and Real-life Nature-based Therapy in Cancer Survivors - a RCT
Overview
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.
Interventions
- Other 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. - 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. - 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.
Primary outcome measures
- Fatigue [Time frame: 8 weeks (end of intervention)]
- Sleep [Time frame: 8 weeks (end of intervention)]
- Depression [Time frame: 8 weeks (end of intervention)]
- Concentration [Time frame: 8 weeks (end of intervention)]
Secondary outcome measures (12)
- Fatigue [Time frame: 8 weeks (end of intervention)]
- Sleep [Time frame: 8 weeks (end of intervention)]
- Depression [Time frame: 8 weeks (end of intervention)]
- Concentration [Time frame: 8 weeks (End of intervention)]
- Resilience [Time frame: 8 weeks (end of intervention)]
- Mindfulness [Time frame: 8 weeks (end of intervention)]
- Anxiety [Time frame: 8 weeks (end of intervention)]
- Quality of life Questionnaire [Time frame: 8 weeks (end of intervention)]
- Sensation of stress [Time frame: 8 weeks (end of intervention)]
- Simulator Disease (Virtual reality group only, arm 2) [Time frame: 8 weeks (end of intervention)]
- Physical Activity and Sport Questionnaire [Time frame: 8 weeks (end of intervention)]
- Safety evaluation [Time frame: Through 8 weeks of intervention (Weeks 0-8)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Germany · 2 centers
- Dr med. Marcela Winkler — Stuttgart
- PD Dr. Claudia Löffler — Würzburg
Identifiers
NCT: NCT06931132 · S00855-NIM