Pilot Observational Study of an Integrative Cure Stay Program
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.)
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Integrative Cure Stay
BehavioralParticipants attend a 7-day integrative oncology retreat including individualized consultations, complementary therapies, and group-based mind-body interventions
Matched Control Group
Other interventionParticipants receive usual oncology follow-up without attending the retreat
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Integrative Cure Stay Group1 intervention
Group B: Matched Control Group1 intervention
Trial outcomes
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.
Time frame
Baseline to 6 monthsSecondary outcomes
1
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).
Time frame
Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.2
Quality of Life (VAS)
The EQ Visual Analog Scale (VAS) provides a subjective "health today" score (0-100).
Time frame
Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.3
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.
Time frame
Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.4
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.
Time frame
Baseline, pre-retreat, last day of retreat, 2 weeks, 1 month, 3 months, 6 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov