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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
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
 (submitted: October 13, 2016)
  • 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
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.

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
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
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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 13, 2016)
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:

  • 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
Sex/Gender
Sexes Eligible for Study: Female
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
Plan to Share IPD: No
Responsible Party The Netherlands Cancer Institute
Study Sponsor The Netherlands Cancer Institute
Collaborators Not Provided
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
PRS Account The Netherlands Cancer Institute
Verification Date September 2016