Shared Decision Making in Surveillance for Distant Metastasis in Breast Cancer

Breast Cancer Clinical Trial

— SMART-FU  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04862078
• Other study ID #: 2012-090-1182
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 6, 2021
• Est. completion date: January 31, 2024

Study information

• Verified date: May 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 368
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Quality of Life
• Survivorship

Intervention

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"
• Usual care
standard follow-up according to the institutional practice

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life (QoL)	Evaluated QoL with Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire	At the point of enrollment
Primary	Quality of life (QoL)	Evaluated QoL with Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire	After 1 year of enrollment
Primary	Quality of life (QoL)	Evaluated QoL with Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire	After 2 year of enrollment
Secondary	Depression-anxiety scale	Evaluated with Hospital Anxiety and Depression Scale (HADS) questionnaire	At the point of enrollment, after 1 year and 2 years
Secondary	Recurrence-free survival (RFS)	Evaluated locoregional / distant metastasis free-survival	3 years
Secondary	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
Secondary	Cross over rate in SDM group	Evaluated Patients' cross-over rate in SDM group	3 years