Breast CancerSMART-FUNCT04862078
Shared Decision Making in Surveillance for Distant Metastasis in Breast Cancer
A study testing Shared decision making in people with Breast Cancer and Survivorship, run by Seoul National University Hospital at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Survivorship, Quality of Life
- What is being tested?
- Shared decision making
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Jul 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Conditions
- Breast Cancer, Survivorship, Quality of Life
- Being tested
- Shared decision making, Usual care
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared decision makingDiagnostic 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 careDiagnostic test
standard follow-up according to the institutional practice
| Study group | Role | What they receive |
|---|---|---|
| Shared decision making group | Experimental | The Study arm - shared decision making when deciding surveillance strategy Receives: Diagnostic Test: Shared decision making |
| Usual surveillance group | Other | The control arm - surveillance with usual care Receives: Diagnostic Test: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (QoL), Depression-anxiety scale
Evaluated QoL with Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire
Measured: At the point of enrollment
Quality of life (QoL), Depression-anxiety scale
Evaluated QoL with Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire
Measured: After 6 month of enrollment
Quality of life (QoL), Depression-anxiety scale
Evaluated QoL with Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire
Measured: After 1 year of enrollment
Quality of life (QoL), Depression-anxiety scale
Evaluated QoL with Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire
Measured: After 2 year of enrollment
Secondary outcomes (2)
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)
Measured: 6 month
Cross over rate in SDM group
Evaluated Patients' cross-over rate in SDM group
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start6 Jul 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyeong-Gon Moon, Seoul National University Hospital
- Investigators
- Hyeong-Gon Moon, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862078
- Sponsor's protocol ID
- 2012-090-1182
- Acronym
- SMART-FU
- Status last verified
- Jul 2024
- First submitted
- 18 Apr 2021
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04862078
- Acronym / sponsor ID
- SMART-FU / 2012-090-1182
- Conditions
- Breast Cancer, Survivorship, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shared decision making group | Experimental | Diagnostic Test: Shared decision makingThe Study arm - shared decision making when deciding surveillance strategy |
| Usual surveillance group | Other | Diagnostic Test: Usual careThe control arm - surveillance with usual care |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared decision makingShared 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" | Diagnostic test | Shared decision making group |
| Usual carestandard follow-up according to the institutional practice | Diagnostic test | Usual surveillance group |
Primary outcome
Quality of life (QoL), Depression-anxiety scale
Time frame: At the point of enrollment
Evaluated QoL with Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire
Quality of life (QoL), Depression-anxiety scale
Time frame: After 6 month of enrollment
Evaluated QoL with Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire
Quality of life (QoL), Depression-anxiety scale
Time frame: After 1 year of enrollment
Evaluated QoL with Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire
Quality of life (QoL), Depression-anxiety scale
Time frame: After 2 year of enrollment
Evaluated QoL with Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire
2 secondary outcomes
Rate of patients who choose guideline-dependent surveillance rather than advanced imaging-dependent in SDM group
Time frame: 6 month
Cross over rate in SDM group
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyeong-Gon Moon principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared decision making in people with Breast Cancer and Survivorship, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (QoL), Depression-anxiety scale (time frame: At the point of enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.