Pilot Observational Study of an Integrative Cure Stay Program
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Integrative Cure Stay, Matched Control Group.
- Кому может быть актуально
- Состояния в реестре: Breast Cancer, Gynecologic Cancer. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Швейцария
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This pilot observational study evaluates the feasibility and acceptability of conducting a prospective study alongside the individualized integrative oncology cure stay program "Via Shalva" for breast and gynecological cancer survivors. The study further explores preliminary changes in patient-reported outcomes, physiological measures, and biological markers before and after the retreat and compared with a matched control group.
Подробное описание
Breast and gynecological cancer survivors frequently experience long-term physical and psychological symptoms after completing primary treatment, including fatigue, anxiety, stress, sleep disturbances, and reduced quality of life. Integrative oncology approaches-such as acupuncture, yoga, mindfulness, psycho-oncological support, and individualized lifestyle counselling-may help alleviate these symptoms, but evidence from structured, prospective research remains limited. "Via Shalva," a 7-day integrative oncology retreat, was developed to address these unmet supportive care needs.
This prospective, exploratory, single-center observational matched cohort study aims to evaluate the feasibility of conducting a clinical study alongside the retreat, including recruitment, retention, adherence, and completeness of data collection. Participants attending the cure stay are compared with a matched control group not participating in the retreat. Study procedures include systematic assessment of patient-reported outcomes, wearable-based physiological data, and biological samples. Measurements are performed longitudinally across six time points over six months.
Secondary exploratory aims include describing potential changes in symptoms, wellbeing, and stress-related biomarkers following the retreat, as well as differences between retreat participants and controls. Findings will inform the design of future randomized controlled trials evaluating integrative oncology interventions and contribute to improving supportive cancer care.
Вмешательства
- Поведенческое Integrative Cure Stay
Participants attend a 7-day integrative oncology retreat including individualized consultations, complementary therapies, and group-based mind-body interventions - Другое Matched Control Group
Participants receive usual oncology follow-up without attending the retreat
Первичные конечные точки
- Feasibility of Study Conduct (Composite Outcome) [Срок оценки: Baseline to 6 months]
Вторичные конечные точки (12)
- Quality of Life (EQ-5D-5L) [Срок оценки: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.]
- Quality of Life (VAS) [Срок оценки: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.]
- Psychological Distress (Distress Thermometer) [Срок оценки: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.]
- Perceived Stress (PSS-10) [Срок оценки: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.]
- Anxiety and Depression (HADS) [Срок оценки: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.]
- Resilience (CD-RISC-10) [Срок оценки: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.]
- Therapy Adherence [Срок оценки: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.]
- Physiological Measures: HRV [Срок оценки: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.]
- Physiological Measures (Pulse) [Срок оценки: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.]
- Physiological Measures (physical activity) [Срок оценки: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.]
- Salivary Cortisol [Срок оценки: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.]
- Salivary Alpha-Amylase (sAA) [Срок оценки: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.]
Критерии участия
Критерии включения
- Breast and gynecological cancer (including but not limited to ovarian, endometrial, cervical, vulvar and vaginal cancer) survivors, including recurrent disease
- Completed primary treatment (operation +/- radiation +/- chemotherapy)
- Age ≥ 18 years
- Ongoing or planned maintenance treatment scheduled for > 3 months during study period is allowed (e.g. antihormonal therapy, Anti-Her2-antibodies, CDK4/6-inhibitors, Anti-VEGF-inhibitor, PARP-inhibitor, immune-checkpoint inhibitors etc.)
- Signed informed consent for participation of the trials
- Presence of a stoma is allowed
- Prior cancer is allowed
- Prior treatment - including chemotherapy - for a prior malignant tumor (including breast or gynecological cancer) is allowed
- Concomitant participation in an experimental therapeutic drug trial is allowed
- Use of other complementary methods (including mistletoe) is allowed
- Pregnancy is allowed.
Критерии исключения
- Language or cognitive deficits (including impaired consciousness) that are incompatible with the participation in the study
- Severe physical or psychiatric comorbidity that prevents a patient from participating in the study
- Patients incapable of giving consent
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Швейцария · 1 центр
- University Hospital Basel — Basel
Идентификаторы
NCT: NCT07398079 · 2025-01722;bb25Heinz-Schwarz7