The Development of a Personalized Decision Aid: Perspectives of Patients and Health Care Professionals on Shared Decision Making and Informational Needs on Radiotherapy for Breast Cancer (M16SDM)
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|ClinicalTrials.gov Identifier: NCT02934126|
Recruitment Status : Completed
First Posted : October 14, 2016
Last Update Posted : September 27, 2017
Background: The Dutch guideline on breast cancer treatment shows several grey areas, where no clear recommendation is given on the radiotherapy options, but where the advice is to discuss the treatment of choice with the patient. Currently, patients are exposed to different information given by the professionals' personal styles of informing patients. The challenge for all oncological professionals is to give clear, structured, and neutral information on the pros and cons of the treatment option(s) in the context of the natural course of the disease to the patient; to elicit patients' needs and preferences. How and which information should be shared in a decision aid is up for investigation, as well as how this should best be implemented.
Research goals: Qualitative assessment of patients' and health care professionals' informational needs and perspectives on breast cancer radiotherapy and shard decision making.
Methods: Semi-structured interviews will be held with both breast cancer patients and health care professionals. To reach as heterogeneous groups as possible patients of different ages, with different education levels and who underwent different treatments or chose not to get radiotherapy at all will be selected . Data will be collected til saturation is reached. Interviews will be transcribed verbatim and analysed using thematic analysis.
Results: Results of the qualitative study are expected at the beginning of 2017.
Hypothesis: Investigating the patients' and health care professionals' perspectives on shared decision making and informational needs on radiotherapeutic options will help the development of a personalized decision aid eligible for broad implementation.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Other: breast cancer patients|
|Study Type :||Observational|
|Actual Enrollment :||15 participants|
|Official Title:||The Development of a Personalized Decision Aid: Perspectives of Patients and Health Care Professionals on Shared Decision Making and Informational Needs on Radiotherapy for Breast Cancer|
|Study Start Date :||September 2016|
|Actual Primary Completion Date :||December 28, 2016|
|Actual Study Completion Date :||December 28, 2016|
breast cancer patients
breast cancer patients who have faced a decision on different types of radiotherapy or to leave radiotherapy out of the treatment
Other: breast cancer patients
semi structured face to face interviews
- Patients' perspectives on informational needs and shared decision making when making a decision on radiation treatment, a qualitative assessment. [ Time Frame: 4 months ]the face-to face interviews will be transcribed verbatim and analyzed using thematic content analysis. The analysis will be performed by two independent researches with help of NVIVO 11
- Health care professionals perspectives' on shared decision making and decision tools when facing a preference-sensitive decision on radiation treatment, a qualitative assesment [ Time Frame: 4 months ]the face-to face interviews will be transcribed verbatim and analyzed using thematic content analysis. The analysis will be performed by two independent researches with help of NVIVO 11
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02934126
|Netherlands Cancer Institute|
|Amsterdam, Netherlands, 1066CX|
|Maastricht, Netherlands, 6229 ET|
|Principal Investigator:||Nicola Russell, MD, PhD||The Netherlands Cancer Institute|
|Principal Investigator:||Liesbeth Boersma, MD, PhD||Maastricht unversity medical center- MAASTRO clinic|
|Principal Investigator:||Trudy van der Weijden, MD, PhD||Maastricht University|