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)
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Amsterdam, Netherlands, 1066CX
- Netherlands Cancer Institute
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Maastricht, Netherlands, 6229 ET
- Maastro Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 2-3 months after facing decision or > 1 year after decision
- able to speak and understand Dutch
- Written informed consent
Exclusion Criteria:
- recurrence of breast cancer prior to interview
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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breast cancer patients
breast cancer patients who have faced a decision on different types of radiotherapy or to leave radiotherapy out of the treatment
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semi structured face to face interviews
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patients' perspectives on informational needs and shared decision making when making a decision on radiation treatment, a qualitative assessment.
Time Frame: 4 months
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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
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4 months
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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
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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
|
4 months
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Collaborators and Investigators
Sponsor
Investigators
- 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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M16SDM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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