Shared Decision Making in Surveillance for Distant Metastasis in Breast Cancer

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer; Survivorship; Quality of Life
• Interventions: Diagnostic Test: Shared decision making; Diagnostic Test: Usual care

• Registration Number: NCT04862078
• Lead Sponsor: Seoul National University Hospital

Brief Summary

In this study, clinical impacts of shared decision making between physicians and patients in strategy of surveillance for asymptomatic patients who ended the primary treatments on quality of life would be investigated

Detailed Description

\[Background\]

1. Shared decision making between patients and physicians when breast cancer patients encounter decision making in the initial treatment process has already been included in the recommendations for breast cancer treatment in each country. However, in the follow-up stage using various imaging tests after the initial breast cancer treatment, the evidence of decision making is very poor and the patient who understands this well and actively participates in the process of deciding the follow-up strategy are almost none.

2. Major guidelines including NCCN, ASCO and ESMO recommend surveillance with routine imaging such as sonography and mammography, and does not recommend advanced imaging tests for asymptomatic patients. These guidelines are based on two prospective randomized trials conducted in 1994. Despite many international medical recommendations, many institutions around the world are increasingly using distant metastasis tests in belief of improving the survival rate through early detection of distant metastasis and of improving the emotional stability of doctors and patients.

3. In this study, clinical impacts of shared decision making in strategy of surveillance for asymptomatic patients on quality of life would be investigated by prospective randomized pragmatic trial. Additionally, oncological results would be analyzed and real world data of patients preference would be gathered

\[Study design\] Prospective, single-institutional, randomized pragmatic trial

\[Statistical considerations\] With 5% significance level and 90% power, 132 patients are needed in each group. Assuming a 28% drop out rate, 368 patients need to be recruited.

\[Randomizations\] Web-based randomization would be conducted stratified to subtypes.

\[Objectives\]

1. Primary objective

- QoL (when enrollment, after 1 and 2 year - FACT-B score)

2. Secondary objectives

* Depression - anxiety scale (HADS score)

* Recurrence-free survival

* Patients' preference for surveillance in SDM group

* Cross over rate in SDM group

Study Timeline

• Study First Submitted: 2021-04-18
• Study First Submitted QC: 2021-04-22
• Study First Posted: 2021-04-27
• Study Start: 2021-07-06
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-08
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 368

Inclusion Criteria

• Women between 20-70 years
• Invasive unilateral breast carcinoma with histological confirmation
• History of invasive breast cancer
• TMN stage I-II according to AJCC 7th
• Histologically or radiologically no suspicion of distant metastases
• Performance status corresponding to ECOG grade 0-2
• No psychological and geographical restriction in follow-up
• Written informed consent

Exclusion Criteria

• History of any cancer in the previous 5 years
• Bilateral breast cancer
• Male breast cancer
• Patients who are planning for surveillance in other institutions
• Unable to understand and fill out questionnaires

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shared decision making group	Shared decision making	The Study arm - shared decision making when deciding surveillance strategy
Usual surveillance group	Usual care	The control arm - surveillance with usual care

Primary Outcome Measures

Name	Time	Method
Quality of life (QoL), Depression-anxiety scale	After 2 year of enrollment	Evaluated QoL with Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire

Secondary Outcome Measures

Name	Time	Method
Rate of patients who choose guideline-dependent surveillance rather than advanced imaging-dependent in SDM group	6 month	Rate of patients who choose guideline-dependent surveillance in SDM group (Patients' preference for surveillance)
Cross over rate in SDM group	2 years	Evaluated Patients' cross-over rate in SDM group

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of