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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 (M16SDM)

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ClinicalTrials.gov Identifier: NCT02934126
Recruitment Status : Completed
First Posted : October 14, 2016
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Study Description
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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.


Condition or disease Intervention/treatment
Breast Cancer Other: breast cancer patients

Detailed Description:
semi-structured interviews with breast cancer patients and health care professionals.
Study Design
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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Netherlands
Netherlands Cancer Institute
Amsterdam, Netherlands, 1066CX
Maastro Clinic
Maastricht, Netherlands, 6229 ET
Sponsors and Collaborators
The Netherlands Cancer Institute
Investigators
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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
More Information
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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT02934126    
Other Study ID Numbers: M16SDM
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases