Shared Decision Making With Breast Cancer Patients

NCT04177628 | Completed

• 1 other identifier: DBCG RT SDM
• Study Type: interventional
• Target: 678
• Locations: 1 country
• Sites: 7

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.

Conditions

Shared Decision Making; Breast Neoplasms; Radiotherapy, Adjuvant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The doctor's perception of patient engagement in the decision making process as measured by the Shared Decision Making Questionnaire doctor 9

  Within one week after the consultation

• The participant's fear of cancer recurrence as measured by the Fear of Cancer Recurrence Short form Questionnaire

  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

  Within one week after the consultation

• The participant's effectiveness in decision making as measured by the Decisional Conflict Scale questionnaire

  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

  Six months after the consultation

Study Arms (2)

Arm A: Shared decision making

EXPERIMENTAL

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

Arm B: Usual practice

NO INTERVENTION

Patients will be informed by a doctor randomized to inform about adjuvant radiotherapy according to usual practice.

Interventions

Shared decision making supported by an in-consultation patient decision aid BEHAVIORAL

After having received training in SDM, the doctor will practice SDM supported by an in-consultation PtDA during the consultation with the participant.

Arm A: Shared decision making

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vejle Hospital: lead
• Danish Breast Cancer Cooperative Group: collaborator
• University of Southern Denmark: collaborator
• Danish Comprehensive Cancer Center: collaborator

Study Sites (7)

Aalborg Hospital

Aalborg, Denmark

Location

Aarhus University Hospital

Aarhus, Denmark

Location

Rigshospitalet

Copenhagen, Denmark

Location

Herlev University Hospital

Herlev, Denmark

Location

Sjaellands University Hospital

Næstved, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

Vejle Hospital

Vejle, Denmark

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Karina D Steffensen, Professor

  Vejle Hospital

  STUDY CHAIR

• Stine R Sondergaard, M.D.

  Vejle Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 26, 2019
• Study Start: March 4, 2020
• Primary Completion: December 31, 2022
• Study Completion: July 31, 2023
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (7)