Clinical trial NCT04177628: Shared Decision Making With Breast Cancer Patients
Official title: Shared Decision Making With Breast Cancer Patients Offered Adjuvant Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shared Decision Making
Breast Neoplasms
Radiotherapy, Adjuvant
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
Collaborators: name: Danish Breast Cancer Cooperative Group
name: University of Southern Denmark
name: Danish Comprehensive Cancer Center
First posted: 2019-11-26
Enrollment: 678
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Half the doctors at each center will receive training in SDM. These doctors will practice SDM supported by the in-consultation PtDA during every consultation in this study. The other half of the doctors will continue usual practice of informing the patients.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this project is to elucidate whether the use of shared decision making will influence patient engagement in the decision making process about adjuvant radiotherapy after breast conserving surgery for local breast cancer or early stages of local breast cancer.

Detailed description: The risk of recurrence of breast cancer is lowered by adjuvant medical treatment as well as by radiotherapy (RT). On the other hand, all adjuvant treatments involve a risk of side effects; some are acute and transient while others are long-term. Considering the well-known side effects of irradiation, it seems appropriate to involve patients in the decision on whether to receive irradiation.

In the shared decision making (SDM) process clinicians and patients work together to make appropriate health decisions based on clinical evidence and the patient's informed preferences. A patient decision aid (PtDA) is instrumental in the SDM process.

This study is a multicenter, national trial randomizing doctors to either use or not use SDM and a PtDA when informing the patients about benefits and risks of receiving adjuvant radiotherapy.

It is not expected that significantly less patients will receive radiotherapy as a consequence of SDM. The primary aim of the study is to evaluate whether patient engagement in decision making is affected by SDM and the use of an in-consultation PtDA.

Eligibility criteria: Inclusion Criteria:

* Histologically verified breast cancer or ductal carcinoma in situ breast cancer
* Candidate for adjuvant radiotherapy Danish Breast Cancer Group type F after breast-conserving surgery for T1-2, N0-Nmi, M0 disease according to national guidelines.
* Signed confirmation of participation.

Exclusion Criteria:

* Bilateral breast cancer or suspicion of disseminated cancer
* Unable to understand the information, the planned treatment or follow-up for any reason.
* Earlier radiotherapy towards the thoracic region.

Primary outcomes:
measure: Participant engagement in the decision making process as measured by the Shared Decision Making Questionnaire 9.
timeFrame: Within one week after the consultation
Secondary outcomes:
measure: The doctor's perception of patient engagement in the decision making process as measured by the Shared Decision Making Questionnaire doctor 9
timeFrame: Within one week after the consultation
measure: The participant's fear of cancer recurrence as measured by the Fear of Cancer Recurrence Short form Questionnaire
timeFrame: Within one week after the consultation and again after six months
measure: The participant's engagement in the decision making process as measured by the Shared Decision Making Process 4 questionnaire
timeFrame: Within one week after the consultation
measure: The participant's effectiveness in decision making as measured by the Decisional Conflict Scale questionnaire
timeFrame: Before (12 items) and within one week after the consultation (all 16 items)
measure: The participant's regret of the treatment decision as measured by the Decision Regret Scale questionnaire
timeFrame: Six months after the consultation
measure: The participant's engagement in the decision making process as measured by the CollaboRATE questionnaire
timeFrame: Within one week after the consultation
measure: The participant's quality of life as measured by the EORCT QLQ-C30 (version 3.0) questionnaire, only question 29 + 30
timeFrame: Six months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Herlev
country: Denmark
facility: Herlev University Hospital
city: Næstved
country: Denmark
facility: Sjaellands University Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Vejle
country: Denmark
facility: Vejle Hospital
Study officials:
affiliation: Vejle Hospital
name: Karina D Steffensen, Professor
role: STUDY_CHAIR
affiliation: Vejle Hospital
name: Stine R Sondergaard, M.D.
role: PRINCIPAL_INVESTIGATOR
References: