Pilot Observational Study of an Integrative Cure Stay Program (Via Shalva)

May 19, 2026 updated by: Isabell Xiang Ge, University Hospital, Basel, Switzerland
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • University Hospital Basel
        • Contact:
        • Principal Investigator:
          • Isabell Ge, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Participants attend a 7-day integrative oncology retreat including individualized consultations, complementary therapies, and group-based mind-body interventions
Matched Control Group
Participants receive usual oncology follow-up without attending the retreat.
Other: Matched Control Group
Participants receive usual oncology follow-up without attending the retreat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Study Conduct (Composite Outcome)
Time Frame: Baseline to 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life (EQ-5D-5L)
Time Frame: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.
Change in health-related quality of life measured using the EQ-5D-5L questionnaire. EQ-5D-5L scoring involves combining responses from 5 dimensions (Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression) into a 5-digit profile with values ranging from 11111 (best possible health state) to 55555 (worst possible health state). A separate EQ Visual Analog Scale (VAS) provides a subjective "health today" score (0-100).
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.
The EQ Visual Analog Scale (VAS) provides a subjective "health today" score (0-100).
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.
Change in psychological distress assessed using the Distress Thermometer, a valid and reliable measure developed by the National Comprehensive Cancer Network for screening psychological distress in cancer patients. The German version was adapted by Mehnert et al. A score of 5 or higher at the visual analogue scale. The score ranges from 0-10 while 10 indicates a higher stress level.
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.
Change in perceived stress levels measured with the 10-item Perceived Stress Scale. PSS-10 measures the degree to which life has been perceived as unpredictable, uncontrollable und overloading over the last month. The responses are rated on a 5-point rating scale with a total score ranging from 0-40 while a higher total score indicating greater stress.
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.

Change in anxiety and depression symptoms measured by the Hospital Anxiety and Depression Scale.

The scale consists of 14 questions, with each question being assigned a value from 0 to 3. The total score can range from 0 to 21. Scores of 8-10 are considered borderline, 11-15 moderate, and 16 or higher severe anxiety or depression.
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.
Change in psychological resilience measured using the CD-RISC-10 questionnaire. It is the shortened version of a 25-items questionnaire which evaluates the patient's ability to bounce back when diagnosed with a disease. The responses are rated on a 5-point rating scale with the total score ranged from 0-40 while a higher total score indicating greater resilience.
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.
Change in adherence to ongoing maintenance therapies assessed via routine visit documentation and follow-up questionnaires.
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.
Change in heart rate variability using a wearable device.
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.
Change in pulse measured using a wearable device.
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.
Change of daily physical activity is evaluated by the number of steps using a wearable device.
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.
Change in diurnal cortisol levels (awakening, +30 min, +1 h, +6 h, +14 h) measured by LC-MS/MS.
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.
Change in salivary alpha-amylase activity as a biomarker of sympathetic activation.
Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.
Serum BDNF
Time Frame: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.
Change in serum brain-derived neurotrophic factor levels measured via ELISA.
Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.
Microbiome Composition
Time Frame: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.
Exploratory changes in gut, oral, and urinary microbiome diversity and composition assessed by 16S rRNA sequencing.
Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.
Subjective Evaluation of the Cure Stay
Time Frame: Daily from day 3 to day 7 of the cure stay
Participants' satisfaction and perceived benefit of the integrative cure stay is assessed by the questionnaire "personal evaluation of the cure stay". Scores ranges from 0-24 while higher scores indicate higher satisfaction.
Daily from day 3 to day 7 of the cure stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Study Chair: Viola Heinzelmann-Schwarz, Prof. MD, University Hospital of Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

January 12, 2026

First Submitted That Met QC Criteria

February 2, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-01722;bb25Heinz-Schwarz7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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