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 |
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Recruitment Status :
Completed
First Posted : October 14, 2016
Last Update Posted : September 27, 2017
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| Tracking Information | ||||||||||
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| First Submitted Date | September 27, 2016 | |||||||||
| First Posted Date | October 14, 2016 | |||||||||
| Last Update Posted Date | September 27, 2017 | |||||||||
| Study Start Date | September 2016 | |||||||||
| Actual Primary Completion Date | December 28, 2016 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures | Not Provided | |||||||||
| Original Secondary Outcome Measures | Not Provided | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief 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 | |||||||||
| 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 | |||||||||
| Brief Summary | 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. |
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| Detailed Description | semi-structured interviews with breast cancer patients and health care professionals. | |||||||||
| Study Type | Observational | |||||||||
| Study Design | Observational Model: Case-Only Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Not Provided | |||||||||
| Sampling Method | Non-Probability Sample | |||||||||
| Study Population | breast cancer patients, who during their treatment faced a decision between different radiation treatments or not to have radiotherapy at all | |||||||||
| Condition | Breast Cancer | |||||||||
| Intervention | Other: breast cancer patients
semi structured face to face interviews
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| Study Groups/Cohorts | breast cancer patients
breast cancer patients who have faced a decision on different types of radiotherapy or to leave radiotherapy out of the treatment
Intervention: Other: breast cancer patients
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Completed | |||||||||
| Actual Enrollment |
15 | |||||||||
| Original Estimated Enrollment | Same as current | |||||||||
| Actual Study Completion Date | December 28, 2016 | |||||||||
| Actual Primary Completion Date | December 28, 2016 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries | Netherlands | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT02934126 | |||||||||
| Other Study ID Numbers | M16SDM | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement |
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| Responsible Party | The Netherlands Cancer Institute | |||||||||
| Study Sponsor | The Netherlands Cancer Institute | |||||||||
| Collaborators | Not Provided | |||||||||
| Investigators |
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| PRS Account | The Netherlands Cancer Institute | |||||||||
| Verification Date | September 2016 | |||||||||