Shared Decision Making in Surveillance for Distant Metastasis in Breast Cancer

NCT ID: NCT04862078

Last Updated: 2024-07-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 368 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-06
• Study Completion Date: 2025-12-31

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

Conditions

Breast Cancer; Survivorship; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Shared decision making group

The Study arm - shared decision making when deciding surveillance strategy

Group Type: EXPERIMENTAL

Shared decision making

Intervention Type: DIAGNOSTIC_TEST

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 surveillance group

The control arm - surveillance with usual care

Group Type: OTHER

Usual care

Intervention Type: DIAGNOSTIC_TEST

standard follow-up according to the institutional practice

Interventions

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"

Intervention Type: DIAGNOSTIC_TEST

Usual care

standard follow-up according to the institutional practice

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hyeong-Gon Moon

Medical doctor, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hyeong-Gon Moon

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2012-090-1182

Identifier Type: -

Identifier Source: org_study_id