Shared Decision Making With Breast Cancer Patients

Shared Decision Making With Breast Cancer Patients Offered Adjuvant Radiotherapy

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms; Shared Decision Making; Radiotherapy, Adjuvant
• Intervention / Treatment: Behavioral: Shared decision making supported by an in-consultation patient decision aid

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.

• Study Type: Interventional
• Enrollment (Actual): 678
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stine R Sondergaard, M.D.; Phone Number: +45 79 40 52 92; Email: stine.rauff.sondergaard@rsyd.dk

Study Locations

• Denmark
  • Aalborg, Denmark
    • Aalborg Hospital
  • Aarhus, Denmark
    • Aarhus University Hospital
  • Copenhagen, Denmark
    • Rigshospitalet
  • Herlev, Denmark
    • Herlev University Hospital
  • Næstved, Denmark
    • Sjaellands University Hospital
  • Odense, Denmark
    • Odense University Hospital
  • Vejle, Denmark
    • Vejle Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Shared decision making; Patients will be informed by a doctor randomized to practice shared decision making and use the in-consultation PtDA during the consultation on adjuvant radiotherapy.	Behavioral: Shared decision making supported by an in-consultation patient decision aid; After having received training in SDM, the doctor will practice SDM supported by an in-consultation PtDA during the consultation with the participant.
No Intervention: Arm B: Usual practice; Patients will be informed by a doctor randomized to inform about adjuvant radiotherapy according to usual practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant engagement in the decision making process as measured by the Shared Decision Making Questionnaire 9.	Minimum value: 0. Maximum value: 100. The higher the value the more patient engagement.	Within one week after the consultation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The doctor's perception of patient engagement in the decision making process as measured by the Shared Decision Making Questionnaire doctor 9	Minimum value: 0. Maximum value: 100. The higher the value the more patient engagement.	Within one week after the consultation
The participant's fear of cancer recurrence as measured by the Fear of Cancer Recurrence Short form Questionnaire	Minimum value: 0. Maximum value: 36. The higher the value the more fear of recurrence.	Within one week after the consultation and again after six months
The participant's engagement in the decision making process as measured by the Shared Decision Making Process 4 questionnaire	Minimum score: 0. Maximum score: 4. The higher the score the more patient engagement.	Within one week after the consultation
The participant's effectiveness in decision making as measured by the Decisional Conflict Scale questionnaire	Minimum value: 0. Maximum value: 100. The higher the value the more effective decision making.	Before (12 items) and within one week after the consultation (all 16 items)
The participant's regret of the treatment decision as measured by the Decision Regret Scale questionnaire	Minimum value: 0. Maximum value: 100. The higher the value the more regret.	Six months after the consultation
The participant's engagement in the decision making process as measured by the CollaboRATE questionnaire	Minimum score: 0. Maximum score: 9. The higher the value the more patient engagement.	Within one week after the consultation
The participant's quality of life as measured by the EORCT QLQ-C30 (version 3.0) questionnaire, only question 29 + 30	Minimum value: 0. Maximum value: 100. The higher the value the more quality of life.	Six months

Collaborators and Investigators

• Sponsor: Vejle Hospital
• Collaborators: University of Southern Denmark; Danish Breast Cancer Cooperative Group; Danish Comprehensive Cancer Center
• Investigators: Study Chair: Karina D Steffensen, Professor, Vejle Hospital; Principal Investigator: Stine R Sondergaard, M.D., Vejle Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: DBCG RT SDM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No