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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00000539

Enrollment

400

Registered

2010-10-07

Start date

2010-01-27

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

C50 C18 C19 C20

Interventions

Group 1: Training program for oncologists including - theoretical background of shared decision-making - implementation of SDM techniques in the medical encounter - risk communication - usage of decis

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
1) Decisional Conflict (Decisional Conflict Scale; O'Connor et al., 2005). 2) Saticfaction with Decision (Saticfaction with Decision Scale; Holmes-Rovner, 1996) 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.	—

Measure

Time frame

1) Decisional Conflict (Decisional Conflict Scale; O'Connor et al., 2005). 2) Saticfaction with Decision (Saticfaction with Decision Scale; Holmes-Rovner, 1996) 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.

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Secondary

Measure	Time frame
• 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)) • Shared decision-Making is assesed with the OPTION Scale (Elwyn et al. 2005) and the Shared-Decision Making Questionnaire-9 (Kriston et al. 2009) 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. • Anxiety and Depression: German Version of the Hospital Anxiety and Depression Scalen (HADS-D; Herrmann-Lingen, Buss & Snaith, 1995)	—

Measure

Time frame

• 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)) • Shared decision-Making is assesed with the OPTION Scale (Elwyn et al. 2005) and the Shared-Decision Making Questionnaire-9 (Kriston et al. 2009) 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. • Anxiety and Depression: German Version of the Hospital Anxiety and Depression Scalen (HADS-D; Herrmann-Lingen, Buss & Snaith, 1995)

—

Countries

Germany

Contacts

Public ContactKatrin Reuter

Universitätsklinik für Psychiatrie und Psychosomatik - Psychiatrie und Psychotherapie

Katrin.Reuter@uniklinik-freiburg.de+49 761 270-6986

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 6, 2026