Clinical trial · Observational
Pilot Observational Study of an Integrative Cure Stay Program
NCT07398079CI-TRIAL-00112337Via ShalvarecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Integrative Cure Stay | Behavioral | — | UNRESOLVED |
| Matched Control Group | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Integrative Cure Stay Group
- description
- Participants attend a 7-day integrative oncology retreat including individualized consultations, complementary therapies, and group-based mind-body interventions.
- interventionNames
- Behavioral: Integrative Cure Stay
- label
- Matched Control Group
- description
- Participants receive usual oncology follow-up without attending the retreat.
- interventionNames
- Other: Matched Control Group
Primary outcomes (1)
- measure
- Feasibility of Study Conduct (Composite Outcome)
- timeFrame
- Baseline to 6 months
- description
- Feasibility of study conduct assessed as a composite outcome based on predefined feasibility criteria, including recruitment rate, retention rate, adherence to study procedures, completeness of data collection, and logistical/operational feasibility. Overall feasibility will be determined by whether predefined thresholds for these criteria are met.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.