Skip to main content
OpenTrials
Completed

NCT Number: NCT04177628

Shared Decision Making With Breast Cancer Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Shared Decision Making Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Radiotherapy, Adjuvant Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg Hospital, Aalborg, Denmark

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Collaborators

  • Danish Breast Cancer Cooperative Group
  • Danish Comprehensive Cancer Center
  • University of Southern Denmark

Registry information

Official study title

Shared Decision Making With Breast Cancer Patients Offered Adjuvant Radiotherapy

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Nov 26, 2019
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.