Clinical trial NCT04862078: Shared Decision Making in Surveillance for Distant Metastasis in Breast Cancer
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Survivorship
Quality of Life
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 368
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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

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

Primary outcomes:
measure: Quality of life (QoL), Depression-anxiety scale
timeFrame: At the point of enrollment
measure: Quality of life (QoL), Depression-anxiety scale
timeFrame: After 6 month of enrollment
measure: Quality of life (QoL), Depression-anxiety scale
timeFrame: After 1 year of enrollment
measure: Quality of life (QoL), Depression-anxiety scale
timeFrame: After 2 year of enrollment
Secondary outcomes:
measure: Rate of patients who choose guideline-dependent surveillance rather than advanced imaging-dependent in SDM group
timeFrame: 6 month
measure: Cross over rate in SDM group
timeFrame: 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hyeong-Gon Moon
role: PRINCIPAL_INVESTIGATOR
References: