Shared Decision Making in Surveillance for Distant Metastasis in Breast Cancer (SMART-FU)
Primary Purpose
Breast Cancer, Survivorship, Quality of Life
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Shared decision making
Usual care
Sponsored by
About this trial
This is an interventional screening trial for Breast Cancer
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Shared decision making group
Usual surveillance group
Arm Description
The Study arm - shared decision making when deciding surveillance strategy
The control arm - surveillance with usual care
Outcomes
Primary Outcome Measures
Quality of life (QoL)
Evaluated QoL with Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire
Quality of life (QoL)
Evaluated QoL with Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire
Quality of life (QoL)
Evaluated QoL with Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire
Secondary Outcome Measures
Depression-anxiety scale
Evaluated with Hospital Anxiety and Depression Scale (HADS) questionnaire
Recurrence-free survival (RFS)
Evaluated locoregional / distant metastasis free-survival
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)
Cross over rate in SDM group
Evaluated Patients' cross-over rate in SDM group
Full Information
NCT ID
NCT04862078
First Posted
April 18, 2021
Last Updated
May 30, 2023
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04862078
Brief Title
Shared Decision Making in Surveillance for Distant Metastasis in Breast Cancer
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 6, 2021 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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]
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Survivorship, Quality of Life
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
368 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Shared decision making group
Arm Type
Experimental
Arm Description
The Study arm - shared decision making when deciding surveillance strategy
Arm Title
Usual surveillance group
Arm Type
Other
Arm Description
The control arm - surveillance with usual care
Intervention Type
Diagnostic Test
Intervention Name(s)
Shared decision making
Intervention Description
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
Intervention Name(s)
Usual care
Intervention Description
standard follow-up according to the institutional practice
Primary Outcome Measure Information:
Title
Quality of life (QoL)
Description
Evaluated QoL with Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire
Time Frame
At the point of enrollment
Title
Quality of life (QoL)
Description
Evaluated QoL with Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire
Time Frame
After 1 year of enrollment
Title
Quality of life (QoL)
Description
Evaluated QoL with Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire
Time Frame
After 2 year of enrollment
Secondary Outcome Measure Information:
Title
Depression-anxiety scale
Description
Evaluated with Hospital Anxiety and Depression Scale (HADS) questionnaire
Time Frame
At the point of enrollment, after 1 year and 2 years
Title
Recurrence-free survival (RFS)
Description
Evaluated locoregional / distant metastasis free-survival
Time Frame
3 years
Title
Rate of patients who choose guideline-dependent surveillance rather than advanced imaging-dependent in SDM group
Description
Rate of patients who choose guideline-dependent surveillance in SDM group (Patients' preference for surveillance)
Time Frame
3 years
Title
Cross over rate in SDM group
Description
Evaluated Patients' cross-over rate in SDM group
Time Frame
3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyeong-Gon Moon
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Shared Decision Making in Surveillance for Distant Metastasis in Breast Cancer
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