Shared Decision Making in Surveillance for Distant Metastasis in Breast Cancer

Study Overview
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Brief Summary
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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
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[Background] 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. 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. 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] Primary objective - QoL (when enrollment, after 1 and 2 year - FACT-B score) Secondary objectives Depression - anxiety scale (HADS score) Recurrence-free survival Patients' preference for surveillance in SDM group Cross over rate in SDM group

Official Title
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Shared Decision Making in Follow-up Imaging Surveillance for Distant Metastasis in Treated Breast Cancer Patients [SMART-FU]: A Prospective, Single-institution, Randomized Pragmatic Trial

Conditions
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Breast Cancer, Survivorship, Quality of Life

Intervention / Treatment
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* Diagnostic Test: Shared decision making
* Diagnostic Test: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shared decision making group<br>The Study arm - shared decision making when deciding surveillance strategy | Diagnostic Test: Shared decision making<br>* Shared decision making and decide surveillance strategy between standard follow-up according to the institutional practice and decide what to do advanced imagings for surveillance and guideline-based surveillance<br>|
| Other: Usual surveillance group<br>The control arm - surveillance with usual care | Diagnostic Test: Usual care<br>* standard follow-up according to the institutional practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (QoL) | Evaluated QoL with Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire | At the point of enrollment | 
| Quality of life (QoL) | Evaluated QoL with Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire | After 1 year of enrollment | 
| Quality of life (QoL) | Evaluated QoL with Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire | After 2 year of enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression-anxiety scale | Evaluated with Hospital Anxiety and Depression Scale (HADS) questionnaire | At the point of enrollment, after 1 year and 2 years | 
| Recurrence-free survival (RFS) | Evaluated locoregional / distant metastasis free-survival | 3 years | 
| Rate of patients who choose guideline-dependent surveillance rather than advanced imaging-dependent in SDM group | Rate of patients who choose guideline-dependent surveillance in SDM group (Patients' preference for surveillance) | 3 years | 
| Cross over rate in SDM group | Evaluated Patients' cross-over rate in SDM group | 3 years |