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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

NCT ID: NCT02934126

Last Updated: 2017-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2016-12-28

Brief Summary

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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.

Detailed Description

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semi-structured interviews with breast cancer patients and health care professionals.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

breast cancer patients

Intervention Type OTHER

semi structured face to face interviews

Interventions

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breast cancer patients

semi structured face to face interviews

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Netherlands Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicola Russell, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Netherlands Cancer Institute

Liesbeth Boersma, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht unversity medical center- MAASTRO clinic

Trudy van der Weijden, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

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Netherlands Cancer Institute

Amsterdam, , Netherlands

Site Status

Maastro Clinic

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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M16SDM

Identifier Type: -

Identifier Source: org_study_id