gms | German Medical Science

Background and status of (inter)national research: According to studies, cancer patients have a high (unmet) need for information on complementary and integrative health care (CIH). Some CIH methods can be recommended on the basis of positive evidence from high quality studies e.g. acupuncture, yoga. Many CIH methods are characterized by their potential to activate patients and to promote their self-efficacy. However, some other CIH methods e.g. herbal drugs or food supplements bear the risk of interactions with chemotherapeutics.

Question and objective: Medical guidelines recommend to actively approach cancer patients about CIH and to discuss potential benefits and risks of individual CIH methods. On the basis of these facts, an evidence-based interprofessional counseling program on CIH will be implemented at four Comprehensive Cancer Centers (Tübingen-Stuttgart, Freiburg, Heidelberg, Ulm) in Baden-Württemberg.

Method: The complex intervention with elements on patient, provider, and system level will be evaluated within a multilayer evaluation design with the confirmatory evaluation referring to the patient level. Patients with a cancer diagnosis within the last 6 months will receive 3 individual consultations on CIH within 3 months (=intervention on patient level). The consultations will be provided by an interprofessional team of specifically qualified medical and nursing staff. An intensive online training program aiming to inform patients on CIH treatment options and risks, to activate and to promote their self-efficacy was developed specifically for the project (=intervention on provider level). Moreover, training on basics of CIH are offered to physicians and nurses in the outpatient setting (=intervention on system/transsectoral level). Primary outcome of the evaluation at patient level is patient activation measured with the PAM-13. Secondary outcomes e.g. quality of life, self-efficacy and clinical parameters will also be assessed at 3 time points (baseline, after 3 months and at 6 months follow-up). The intervention group (n=2000) will be compared with a control group (n=500, no CIH counselling) with the same data collection times. In addition the use of health services will be compared with a reference group (n= 2000) based on health insurance data from the local AOK Baden-Wuerttemberg. A qualitative-quantitative process evaluation using interviews, focus groups and questionnaires will examine outcomes on provider and system level e.g. interprofessional collaboration and job satisfaction. Furthermore, the quality of the implementation process as well as relevant barriers and supporting factors for a later implementation will be assessed. A health economic evaluation will complement these analyses. Intervention phase has started in 01/2021.

Discussion: Evaluating such complex interventions as the presented CIH counselling program under everyday conditions is a methodical challenge. However, a comprehensive multilayer perspective is highly relevant to understand the impact of this specific CIH health service on patient-centered outcomes as well as on possible changes on collaboration of different professions and across health care sectors.