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

Completed

• Conditions: Breast Cancer
• Interventions: Other: breast cancer patients

• Registration Number: NCT02934126
• Lead Sponsor: The Netherlands Cancer Institute

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 Timeline

• Status Verified: 2016-09
• Study Start: 2016-09
• Study First Submitted: 2016-09-27
• Study First Submitted QC: 2016-10-13
• Study First Posted: 2016-10-14
• Primary Completion: 2016-12-28
• Study Completion: 2016-12-28
• Last Update Submitted: 2017-09-26
• Last Update Posted: 2017-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
breast cancer patients	breast cancer patients	breast cancer patients who have faced a decision on different types of radiotherapy or to leave radiotherapy out of the treatment

Primary Outcome Measures

Name	Time	Method
Patients' perspectives on informational needs and shared decision making when making a decision on radiation treatment, a qualitative assessment.	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	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

Trial Locations

Locations (2)

Maastro Clinic; 🇳🇱 Maastricht, Netherlands

Netherlands Cancer Institute; 🇳🇱 Amsterdam, Netherlands