Trial document
DRKS00000539
Trial Description
Title
Efficacy of a combined shared decision-making intervention including a training program for oncologists and decision aids for breast and colon cancer patients
Trial Acronym
PPO
URL of the Trial
Brief Summary in Lay Language
Many cancer patients wish to get detailed information about their condition and treatment options as well as to participate in medical decision making. The enhancement of participation in medical decision making can reduce decisional conflict and psychological distress. Clinical studies show, that patients are more satisfied with their treatment and suffer less anxiety and depressive symptoms after being actively involved in the decision making process. To enhance patient participation, a combination of training for oncologists and decision boards for the patients has been shown to be effective. In this study, the efficacy of a training program for shared decision-making in combination with decision boards will be investigated. Aim of this combined intervention is to reduce decional conflict, to enhance satisfaction with the treatment decisions and also to reduce psychological distresss.
Brief Summary in Scientific Language
Aim of the Study:
To adapt and evaluate a combined shared decision making intervention consisting of a training program for oncologists and decision boards for patients suffering from primary breast cancer or colon cancer. Primary hypotheses are that the intervention reduces decisional conflict and enhances satisfaction with medical decisions. Secondary hypothesis is that patients in the intervention group experience less psychological distress. Furthermore, we expect better communication skill in the trained oncologists compared to the control condition.
Design and Methods:
In a Cluster-randomized controlled trial, 50 oncologists (25 in the intervention and control group each) and 400 patients with primary breast cancer or colon cancer will be included. The intervention consists of an existing training manual that has been evaluated for other medical conditions (depression, fibromyalgia) and decision boards. The decision boards will be developed during the first phase of the study. After a baseline assessment (audio-taped consultation), each participating oncologist will include 8 patients in the study. All consultations are audiotaped. In addition, patients and oncologists complete a questionnaire immediately after the consultation. Patients receive a postal follow-up questionnaire 3 months after the consultation.
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00000539
- 2010/10/07
- 2007/06/01
- yes
- Approved
- 274/06, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Secondary IDs
- UKF001133 (Register klinischer Studien des Universitätsklinikums Freiburg)
Health Condition or Problem studied
- C50 - Malignant neoplasm of breast
- C18 - Malignant neoplasm of colon
- C19 - Malignant neoplasm of rectosigmoid junction
- C20 - Malignant neoplasm of rectum
Interventions/Observational Groups
-
Training program for oncologists including
- theoretical background of shared decision-making
- implementation of SDM techniques in the medical encounter
- risk communication
- usage of decision boards
Part two of the combined intervention are decision boards for several medical decisions in the treatment of primary breast cancer and colon cancer - no intervention, treatment as usual (TAU)
Characteristics
- Interventional
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- Randomized controlled trial
- Open (masking not used)
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- Other
- Treatment
- Parallel
- N/A
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Primary Outcome
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.
Secondary Outcome
• 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 of Recruitment
- Germany
Locations of Recruitment
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Recruitment
- Actual
- 2010/01/27
- 400
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- no minimum age
- no maximum age
Additional 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
Addresses
-
start of 1:1-Block address primary-sponsor
- Universitätsklinikum Freiburg Psychiatrie und Psychotherapie Sektion Klinische Epidemiologie und Versorgungsforschung
- Mr. Prof. Dr. Dr. Martin Härter
- Hauptstr. 5
- 79104 Freiburg
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- 0761 / 270 - 6900
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- martin.haerter at uniklinik-freiburg.de
- http://www.uniklinik-freiburg.de/psych/live/sektionen/sektion-epivefo.html
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Universitätsklinikum Heidelberg Klinik für Psychosomatische und Allgemeine Klinische Medizin
- Ms. Dr. med. Christiane Bieber
- Thibautstraße 2
- 69115 Heidelberg
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 06221/5638657
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- Christiane.Bieber at med.uni-heidelberg.de
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end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Universitätsklinik für Psychiatrie und Psychosomatik - Psychiatrie und Psychotherapie
- Ms. Dr. Katrin Reuter
- Hauptstr. 5
- 79104 Freiburg
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49 761 270-6986
- +49 761 270-6989
- Katrin.Reuter at uniklinik-freiburg.de
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end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Deutsche Krebshilfe e.V.
- Ms. Annika Thiel
- Buschstr. 32
- 53113 Bonn
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- 02 28/7 29 90-220
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- annika.thiel at krebshilfe.de
- http://www.krebshilfe.de
end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up complete
- 2012/06/05
Trial Publications, Results and other Documents
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