Clinical trial NCT02934126: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2016-10-14
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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

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.

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

Primary outcomes:
measure: Patients' perspectives on informational needs and shared decision making when making a decision on radiation treatment, a qualitative assessment.
timeFrame: 4 months
measure: Health care professionals perspectives' on shared decision making and decision tools when facing a preference-sensitive decision on radiation treatment, a qualitative assesment
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
city: Maastricht
country: Netherlands
facility: Maastro Clinic
Study officials:
affiliation: The Netherlands Cancer Institute
name: Nicola Russell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht unversity medical center- MAASTRO clinic
name: Liesbeth Boersma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University
name: Trudy van der Weijden, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: