Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07398079

Pilot Observational Study of an Integrative Cure Stay Program

Status
Recruiting
Phase
Study type
Observational
Enrollment
30 (estimated)
Sponsor
University Hospital, Basel, Switzerland · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

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

Interventions

TypeNameDescription
BEHAVIORALIntegrative Cure StayParticipants attend a 7-day integrative oncology retreat including individualized consultations, complementary therapies, and group-based mind-body interventions
OTHERMatched Control GroupParticipants receive usual oncology follow-up without attending the retreat

Timeline

Start date
2025-10-06
Primary completion
2026-12-01
Completion
2027-06-01
First posted
2026-02-09
Last updated
2026-02-09

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT07398079. Inclusion in this directory is not an endorsement.