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

NCT02934126 | Completed

• 1 other identifier: M16SDM
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

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

Interventions

breast cancer patients OTHER

semi structured face to face interviews

breast cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• months after facing decision or \> 1 year after decision
• able to speak and understand Dutch
• Written informed consent

You may not qualify if:

• recurrence of breast cancer prior to interview

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (2)

Netherlands Cancer Institute

Amsterdam, 1066CX, Netherlands

Location

Maastro Clinic

Maastricht, 6229 ET, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: October 14, 2016
• Study Start: September 1, 2016
• Primary Completion: December 28, 2016
• Study Completion: December 28, 2016
• Last Updated: September 27, 2017

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)