Efficacy of a combined shared decision-making intervention including a training program for oncologists and decision aids for breast and colon cancer patients

Not Applicable

• Conditions: C50; C18; C19; C20; Malignant neoplasm of breast; Malignant neoplasm of colon; Malignant neoplasm of rectosigmoid junction; Malignant neoplasm of rectum

• Registration Number: DRKS00000539
• Lead Sponsor: niversitätsklinikum FreiburgPsychiatrie und PsychotherapieSektion Klinische Epidemiologie und Versorgungsforschung

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-07
• Study Completion: 2012-06-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

patients suffering from primary breast cancer or colon cancer facing a medical decision
- informed consent for study participation

Exclusion Criteria

- Cancer Patients that do not face a medical decision
- secondary tumors
- distant metastases
- medical contraindications
- insufficiant knowledge of German language

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Decisional Conflict (Decisional Conflict Scale; O'Connor et al., 2005).<br>2) Saticfaction with Decision (Saticfaction with Decision Scale; Holmes-Rovner, 1996)<br><br>Both primary endpoints are assessed by psychometrically defined scales. Patients complete a questionnaire including these scales immediately after the medical consultation. We expect the decisional conflict to be lower and the satisfaction with decision to be higher in the intervention group, compared with the control group.

Secondary Outcome Measures

Name	Time	Method
• Quality of the doctor-patient relationship: operationalized by the German translation of the consultation and relational empathy (CARE; (Neumann, Wirtz, Bollschweiler, Warm, Wolf & Pfaff, 2008)) <br><br>• Shared decision-Making is assesed with the OPTION Scale (Elwyn et al. 2005) and the Shared-Decision Making Questionnaire-9 (Kriston et al. 2009) <br><br>The OPTION Scale is a coding system for audio-or video-taped consultations - blinded study assistants will rate the extent of shared decision making in the consultation. All other outcomes are included in a patient questionnaire that will be completed immediately after the consultation.<br>• Anxiety and Depression: German Version of the Hospital Anxiety and Depression Scalen (HADS-D; Herrmann-Lingen, Buss & Snaith, 1995)