Pilot Observational Study of an Integrative Cure Stay Program

NCT07398079 | Recruiting

• 1 other identifier: 2025-01722;bb25Heinz-Schwarz7
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer; Gynecologic Cancer

Keywords

Complementary Therapies; Integrative Medicine; Feasibility Studies

Outcome Measures

Primary Outcomes (1)

• Feasibility of Study Conduct (Composite Outcome)

  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.

  Baseline to 6 months

Secondary Outcomes (15)

• Quality of Life (EQ-5D-5L)

  Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.

• Quality of Life (VAS)

  Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.

• Psychological Distress (Distress Thermometer)

  Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.

• Perceived Stress (PSS-10)

  Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.

• Anxiety and Depression (HADS)

  Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.

Study Arms (2)

Integrative Cure Stay Group

Participants attend a 7-day integrative oncology retreat including individualized consultations, complementary therapies, and group-based mind-body interventions.

Behavioral: Integrative Cure Stay

Matched Control Group

Participants receive usual oncology follow-up without attending the retreat.

Other: Matched Control Group

Interventions

Integrative Cure Stay BEHAVIORAL

Participants attend a 7-day integrative oncology retreat including individualized consultations, complementary therapies, and group-based mind-body interventions

Integrative Cure Stay Group

Matched Control Group OTHER

Participants receive usual oncology follow-up without attending the retreat

Matched Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Breast and gynecological cancer survivors who have completed primary treatment (surgery ± chemotherapy ± radiotherapy) and continue to experience long-term physical or psychological symptoms. A matched control group consists of similar patients not attending the integrative cure stay program.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Viola Heinzelmann-Schwarz, Prof. MD

  University Hospital of Basel

  STUDY CHAIR

Central Study Contacts

Isabell Ge, MD

CONTACT

+41 61 32 85885; Isabellxiang.ge@usb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: February 9, 2026
• Study Start: October 6, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)