Pilot Observational Study of an Integrative Cure Stay Program
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: Integrative Cure Stay, Matched Control Group.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Gynecologic Cancer. Basic parameters: from 18 years · Female.
- 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
- Switzerland
- 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 →
Overview
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.
Detailed 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.
Interventions
- Behavioral Integrative Cure Stay
Participants attend a 7-day integrative oncology retreat including individualized consultations, complementary therapies, and group-based mind-body interventions - Other Matched Control Group
Participants receive usual oncology follow-up without attending the retreat
Primary outcome measures
- Feasibility of Study Conduct (Composite Outcome) [Time frame: Baseline to 6 months]
Secondary outcome measures (12)
- Quality of Life (EQ-5D-5L) [Time frame: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.]
- Quality of Life (VAS) [Time frame: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.]
- Psychological Distress (Distress Thermometer) [Time frame: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.]
- Perceived Stress (PSS-10) [Time frame: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.]
- Anxiety and Depression (HADS) [Time frame: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.]
- Resilience (CD-RISC-10) [Time frame: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.]
- Therapy Adherence [Time frame: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.]
- Physiological Measures: HRV [Time frame: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.]
- Physiological Measures (Pulse) [Time frame: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.]
- Physiological Measures (physical activity) [Time frame: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.]
- Salivary Cortisol [Time frame: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.]
- Salivary Alpha-Amylase (sAA) [Time frame: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 1 center
- University Hospital Basel — Basel
Identifiers
NCT: NCT07398079 · 2025-01722;bb25Heinz-Schwarz7