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Shared Decision Making With Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04177628
Recruitment Status : Active, not recruiting
First Posted : November 26, 2019
Last Update Posted : January 10, 2023
Sponsor:
Collaborators:
Danish Breast Cancer Cooperative Group
University of Southern Denmark
Danish Comprehensive Cancer Center
Information provided by (Responsible Party):
Vejle Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Shared Decision Making Breast Neoplasms Radiotherapy, Adjuvant Behavioral: Shared decision making supported by an in-consultation patient decision aid Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 678 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Shared Decision Making With Breast Cancer Patients Offered Adjuvant Radiotherapy
Actual Study Start Date : March 4, 2020
Actual Primary Completion Date : December 31, 2022
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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.


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


Secondary Outcome Measures :
  1. The doctor's perception of patient engagement in the decision making process as measured by the Shared Decision Making Questionnaire doctor 9 [ Time Frame: Within one week after the consultation ]
    Minimum value: 0. Maximum value: 100. The higher the value the more patient engagement.

  2. The participant's fear of cancer recurrence as measured by the Fear of Cancer Recurrence Short form Questionnaire [ Time Frame: Within one week after the consultation and again after six months ]
    Minimum value: 0. Maximum value: 36. The higher the value the more fear of recurrence.

  3. The participant's engagement in the decision making process as measured by the Shared Decision Making Process 4 questionnaire [ Time Frame: Within one week after the consultation ]
    Minimum score: 0. Maximum score: 4. The higher the score the more patient engagement.

  4. The participant's effectiveness in decision making as measured by the Decisional Conflict Scale questionnaire [ Time Frame: Before (12 items) and within one week after the consultation (all 16 items) ]
    Minimum value: 0. Maximum value: 100. The higher the value the more effective decision making.

  5. The participant's regret of the treatment decision as measured by the Decision Regret Scale questionnaire [ Time Frame: Six months after the consultation ]
    Minimum value: 0. Maximum value: 100. The higher the value the more regret.

  6. The participant's engagement in the decision making process as measured by the CollaboRATE questionnaire [ Time Frame: Within one week after the consultation ]
    Minimum score: 0. Maximum score: 9. The higher the value the more patient engagement.

  7. The participant's quality of life as measured by the EORCT QLQ-C30 (version 3.0) questionnaire, only question 29 + 30 [ Time Frame: Six months ]
    Minimum value: 0. Maximum value: 100. The higher the value the more quality of life.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04177628


Locations
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Denmark
Aalborg Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Herlev University Hospital
Herlev, Denmark
Sjaellands University Hospital
Næstved, Denmark
Odense University Hospital
Odense, Denmark
Vejle Hospital
Vejle, Denmark
Sponsors and Collaborators
Vejle Hospital
Danish Breast Cancer Cooperative Group
University of Southern Denmark
Danish Comprehensive Cancer Center
Investigators
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Study Chair: Karina D Steffensen, Professor Vejle Hospital
Principal Investigator: Stine R Sondergaard, M.D. Vejle Hospital
More Information
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Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT04177628    
Other Study ID Numbers: DBCG RT SDM
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: January 10, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases