Shared Decision Making in Surveillance for Distant Metastasis in Breast Cancer (SMART-FU)

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Quality of Life; Breast Cancer; Survivorship
• Intervention / Treatment: Diagnostic test: Shared decision making; Diagnostic test: Usual care

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 Type: Interventional
• Enrollment (Estimated): 368
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shared decision making group; The Study arm - shared decision making when deciding surveillance strategy	Diagnostic test: Shared decision making; 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"
Other: Usual surveillance group; The control arm - surveillance with usual care	Diagnostic test: Usual care; standard follow-up according to the institutional practice

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Hyeong-Gon Moon, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2021
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: April 18, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2012-090-1182

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No