Pilot Observational Study of an Integrative Cure Stay Program (Via Shalva)
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About
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.
Full description
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.
Enrollment
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Volunteers
Inclusion criteria
- 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.
Exclusion criteria
- 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
Trial design
30 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Isabell Ge, MD
Data sourced from clinicaltrials.gov
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