Skip to content

Implementation of a cross-sectoral, interprofessional counseling program for complementary and integrative health care at CCCs in Baden-Württemberg

Implementation of a cross-sectoral, interprofessional counseling program for complementary and integrative health care at CCCs in Baden-Württemberg

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00021779
Enrollment
1500
Registered
2020-06-12
Start date
2020-08-13
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C00-D48

Interventions

Group 1: Description of the intervention and intervention group: The core element consists of an interprofessional, evidence-based counselling service for patients in need of CIH counseling. The couns

Sponsors

Universitätsklinikum Tübingen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: The following inclusion criteria apply to both the intervention group and the control group: - Diagnosis of the cancer including progress or recurrence within the last 6 months (all cancer entities can be included) - Patients must be able to participate in consultation on site/at the CCC - Treatment at one of the participating CCCs or patients at the CCCs for a second opinion - Age >18 y. - Desire/need for complementary medical advice (proven by active contact with the local counselling services) by email, telephone or in person - Signed consent to the study and data protection (Informed consent)

Exclusion criteria

Exclusion criteria: Reasons for exclusion: - For intervention group: participation in control group - For reference group: participation in intervention group or control group - Linguistic or cognitive limitations that prevent patients from completing questionnaires by themselves.

Design outcomes

Primary

MeasureTime frame
The evaluation is based on the following questions: 1. can the new healthcare model be implemented and carried out at all four CCCs as planned? The answer to this question will be operationalised by means of the following parameters: a.) actual implementation of the counselling services (hiring of personnel, implementation of the training, availability of the counselling services) b.) Patient acceptance (number of patients included in the intervention group) c.) Evaluation of the counselling ("intervention fidelity" evaluated by means of the "Red Interaction Analysis System" (RIAS) with regard to pre-defined objectives 2. What effects does the new health care form have on structures, processes and results at the patient, provider and system level? In order to answer this question, the target parameters are collected and analysed, whereby PAM-13 (patient activation), collected at patient level at time T2, is the main target parameter with regard to the assessment of the intervention effect. Primary target parameter at patient level: patient activation (PAM-13)

Secondary

MeasureTime frame
quantitative and qualitative survey instruments at patient level: EQ 5D- (health questionnaire) SES6G-six-item Self-Efficacy Scale (Self-confidence in dealing with chronic disease questionnaire) NEQ- Needs Evaluation Questionaire (outpatients) EORTC QLQ C30- quality of life of cancer patients Questionnaire PHQ-9 Patient Health Questionnaire EORTC FA 12-Quality of Life Module Measuring Cancer Related Fatigue MIDOS2-Minimum documentation system for troublesome symptoms MYCaW- Measure Yourself Concerns and Wellbeing SILS- Single Item Literacy Screener HCU-Q Health Care Utilization-Questionnaire Qualitatively: 10 interviews (per site) with semi-standardised questionnaires 5-10 (per site) counselling interviews are recorded / audio analysis with an evaluation concept (RIAS) to be defined Provider level: quantitative and qualitative survey instruments for teams of doctors and nurses (directly involved in the counselling intervention): Quantitative: Self-assessment of counselling competence and knowledge growth (based on KOMPass) Job satisfaction (WCW) Inter-professional cooperation (AITCS / ISVS) Qualitatively: semi-standardized interviews (all participants) Audio analyses of consultation sessions (5-10 per site) 2 focus groups per site (consultant teams) Cross-site focus group after the end of the intervention Other doctors/nurses (not directly involved in the consultation; cross-sectoral (CCC staff, family doctors, nursing services)) Quantitatively: Evaluation of the advisory services for patients Evaluation of KMPbasic Qualitatively: semi-standardised interviews (2-3 doctors/nurses of the CCCs and general practitioners/outpatient nursing services per site)

Countries

Germany

Contacts

Public ContactDaniela Fröhlich

Institut für Allgemeinmedizin und Interprofessionelle Versorgung (IAIV)

Daniela.Froehlich2@med.uni-tuebingen.de07071 2987781

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 13, 2026