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

Breast Cancer Clinical Trial

— M16SDM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02934126
• Other study ID #: M16SDM
• Status: Completed
• Phase: N/A
• First received: September 27, 2016
• Last updated: September 26, 2017
• Start date: September 2016
• Est. completion date: December 28, 2016

Study information

• Verified date: September 2016
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 28, 2016
• Est. primary completion date: December 28, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• breast cancer patients
semi structured face to face interviews

Locations

Country	Name	City	State
Netherlands	Netherlands Cancer Institute	Amsterdam
Netherlands	Maastro Clinic	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients' perspectives on informational needs and shared decision making when making a decision on radiation treatment, a qualitative assessment.	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
Primary	Health care professionals perspectives' on shared decision making and decision tools when facing a preference-sensitive decision on radiation treatment, a qualitative assesment	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