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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.
• Другое 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.
• Другое 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.

Первичные конечные точки

• Fatigue [Срок оценки: 8 weeks (end of intervention)]
• Sleep [Срок оценки: 8 weeks (end of intervention)]
• Depression [Срок оценки: 8 weeks (end of intervention)]
• Concentration [Срок оценки: 8 weeks (end of intervention)]

Вторичные конечные точки (12)

• Fatigue [Срок оценки: 8 weeks (end of intervention)]
• Sleep [Срок оценки: 8 weeks (end of intervention)]
• Depression [Срок оценки: 8 weeks (end of intervention)]
• Concentration [Срок оценки: 8 weeks (End of intervention)]
• Resilience [Срок оценки: 8 weeks (end of intervention)]
• Mindfulness [Срок оценки: 8 weeks (end of intervention)]
• Anxiety [Срок оценки: 8 weeks (end of intervention)]
• Quality of life Questionnaire [Срок оценки: 8 weeks (end of intervention)]
• Sensation of stress [Срок оценки: 8 weeks (end of intervention)]
• Simulator Disease (Virtual reality group only, arm 2) [Срок оценки: 8 weeks (end of intervention)]
• Physical Activity and Sport Questionnaire [Срок оценки: 8 weeks (end of intervention)]
• Safety evaluation [Срок оценки: Through 8 weeks of intervention (Weeks 0-8)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Германия · 2 центра

• Dr med. Marcela Winkler — Stuttgart
• PD Dr. Claudia Löffler — Würzburg

Идентификаторы

NCT: NCT06931132 · S00855-NIM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗