C00-C97
Conditions
Interventions
Group 1: The intervention of the study consists of two phases for the intervention group.
Phase I: Physicians of the intervention group receive a training, which should qualify them to communicate w
Sponsors
Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie, Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Physicians: • Working in hospitals or private practices with cancer patients • Little knowledge and experience in complementary medicine • Possibility to conduct 10 consultations during working hours, possibility to take part in the on-site skills training in Berlin, • Good German language skills (can have a conversation about complementary medicine with a patient in German), informed consent Patients: • 18 years or older • Diagnosed with cancer • In treatment in a participating hospital or private practices • Antitumor therapy planned or ongoing • Indicate interest in having one conversation about complementary therapies in oncology treatment. • Answers the question: ‘Are you interested in getting information about complementary medicine in cancer care from your oncologist’ with ‘Yes’ • Good german language skills (can have a conversation about complementary medicine and can ask questions about the topic) • Informed consent
Exclusion criteria
Exclusion criteria: Physicians: • radiation oncologists Patients • Patients with cognitive impairment (based on the subjective assessment of the physician that complex information cannot be transferred)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This is not a confirmatory trial and no primary outcome was determined. Multiple main outcomes were defined. Main outcomes on physician level: • Perceived consultation skill-competency for predefined situations, which could occur in the consultation about complementary medicine (adapted instrument, rating on numerical rating scale (NRS)) • Physician’s perceived stress reaction in a consultation situation (stress reduction in a consultation situation, NRS) Main outcomes on patient level: • Quality of communication/relation with the professional (EORTC QLQ-COMU26) • Satisfaction with the information about complementary medicine (adapted version PS-CaTE) • Preparation for decision (PrepDM) Main outcomes on physician-patient-interaction level: • Performance during the communication with simulation patients (protocol-tailored inventory) including a systematic external rating by two independent raters who rate the performance of the communication about complementary medicine according to the guideline and the interactive and communicative competencies (adapted version MAPI) Outcomes are measured on three different levels (physician, patient and interaction level). All physicians are evaluated at several time points. First, by using a web-based documentation physicians provide baseline information (prior to training). Second, the physicians complete a paper-pencil questionnaire after each communication with/ handout of the information leaflet to 10 of their patients. Third, the physicians answer a paper-pencil questionnaire after they have completed all 10 patients. Patients will complete paper-pencil questionnaires at baseline (prior to the communication/ handout of the information leaflet) and two weeks after the communication/ handout of the information leaflet. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: Secondary endpoints on physician level: • Level of complementary medicine knowledge in cancer care (multiple-choice questions in form of a progress-test) • Expectations regarding the effectiveness and side effects of complementary medicine • Personal attitude towards complementary medicine (assessed in a series of predefined situations (Situational Judgement Test)) • Personal attitude towards complementary medicines after knowing the results of the Situational Judgement test that are based on expert ratings (Situational Judgement Test) • Application of the project-developed complementary medicine in cancer care communication guideline (multiple-choice questions based on examples of specific situations) • Challenges in consultations about complementary medicine • Handling challenges in consultations about complementary medicine therapies (Situational Judgement Test) • Implementation of the guideline-based consultation in the treating oncologists’ daily work • Duration of the complementary medicine consultation • Reasons for longer communications than 20 min Secondary endpoints on patient level: • Knowledge of complementary medicine in cancer care (multiple-choice question) • Use of the recommended reputable websites about complementary medicine in cancer care and subjectively experienced usefulness (NRS) of the websites • Physician’s attitudes towards complementary therapies (NRS) • Use of complementary medicine therapies | — |
Countries
Germany
Contacts
Public ContactAlizé Rogge
Institut für Sozialmedizin, Epidemiologie und GesundheitsökonomieCharité - Universitätsmedizin Berlin
Outcome results
None listed