Breast CancerVia ShalvaNCT07398079
Pilot Observational Study of an Integrative Cure Stay Program
An observational study of Breast Cancer and Gynecologic Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Gynecologic Cancer
- What is being tested?
- Integrative Cure Stay
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Oct 2025to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Isabell Ge, MD, +41 61 32 85885, Isabellxiang.ge@usb.ch
Isabell Ge, MD
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, Gynecologic Cancer
- Being tested
- Integrative Cure Stay, Matched Control Group
- Keywords
- Complementary Therapies, Integrative Medicine, Feasibility Studies
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative Cure StayBehavioural
Participants attend a 7-day integrative oncology retreat including individualized consultations, complementary therapies, and group-based mind-body interventions
Matched Control GroupOther
Participants receive usual oncology follow-up without attending the retreat
| Study group | Role | What they receive |
|---|---|---|
| Integrative Cure Stay Group | Participants attend a 7-day integrative oncology retreat including individualized consultations, complementary therapies, and group-based mind-body interventions. Receives: Behavioral: Integrative Cure Stay | |
| Matched Control Group | Participants receive usual oncology follow-up without attending the retreat. Receives: Other: Matched Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 months
Secondary outcomes (15)
Quality of Life (EQ-5D-5L)
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).
Measured: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.
Quality of Life (VAS)
The EQ Visual Analog Scale (VAS) provides a subjective "health today" score (0-100).
Measured: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.
Psychological Distress (Distress Thermometer)
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.
Measured: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.
Perceived Stress (PSS-10)
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.
Measured: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.
Anxiety and Depression (HADS)
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.
Measured: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.
Resilience (CD-RISC-10)
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.
Measured: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.
Therapy Adherence
Change in adherence to ongoing maintenance therapies assessed via routine visit documentation and follow-up questionnaires.
Measured: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.
Physiological Measures: HRV
Change in heart rate variability using a wearable device.
Measured: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.
Physiological Measures (Pulse)
Change in pulse measured using a wearable device.
Measured: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.
Physiological Measures (physical activity)
Change of daily physical activity is evaluated by the number of steps using a wearable device.
Measured: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.
Salivary Cortisol
Change in diurnal cortisol levels (awakening, +30 min, +1 h, +6 h, +14 h) measured by LC-MS/MS.
Measured: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.
Salivary Alpha-Amylase (sAA)
Change in salivary alpha-amylase activity as a biomarker of sympathetic activation.
Measured: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.
Serum BDNF
Change in serum brain-derived neurotrophic factor levels measured via ELISA.
Measured: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.
Microbiome Composition
Exploratory changes in gut, oral, and urinary microbiome diversity and composition assessed by 16S rRNA sequencing.
Measured: Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.
Subjective Evaluation 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.
Measured: Daily from day 3 to day 7 of the cure stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start6 Oct 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabell Xiang Ge, University Hospital, Basel, Switzerland
- Investigators
- Viola Heinzelmann-Schwarz, Prof. MD, Study chair, University Hospital of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398079
- Sponsor's protocol ID
- 2025-01722;bb25Heinz-Schwarz7
- Other IDs
- 2025
- Acronym
- Via Shalva
- Status last verified
- Feb 2026
- First submitted
- 12 Jan 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Observational Study of an Integrative Cure Stay Program
- ClinicalTrials.gov ID
- NCT07398079
- Acronym / sponsor ID
- Via Shalva / 2025-01722;bb25Heinz-Schwarz7
- Conditions
- Breast Cancer, Gynecologic Cancer
- Keywords
- Complementary Therapies, Integrative Medicine, Feasibility Studies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrative Cure Stay Group | – | Behavioral: Integrative Cure StayParticipants attend a 7-day integrative oncology retreat including individualized consultations, complementary therapies, and group-based mind-body interventions. |
| Matched Control Group | – | Other: Matched Control GroupParticipants receive usual oncology follow-up without attending the retreat. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrative Cure StayParticipants attend a 7-day integrative oncology retreat including individualized consultations, complementary therapies, and group-based mind-body interventions | Behavioural | Integrative Cure Stay Group |
| Matched Control GroupParticipants receive usual oncology follow-up without attending the retreat | Other | Matched Control Group |
Primary outcome
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.
15 secondary outcomes
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.
Serum BDNF
Time frame: 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.
Subjective Evaluation of the Cure Stay
Time frame: Daily from day 3 to day 7 of the cure stay
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Viola Heinzelmann-Schwarz, Prof. MD study chair
University Hospital of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Gynecologic Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabell Ge, MD (+41 61 32 85885, Isabellxiang.ge@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Study Conduct (Composite Outcome) (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.