Shared Decision Making in Surveillance for Distant Metastasis in Breast Cancer

NCT04862078 | Active Not Recruiting DMC

• 1 other identifier: 2012-090-1182
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer; Survivorship; Quality of Life

Outcome Measures

Primary Outcomes (4)

• Quality of life (QoL), Depression-anxiety scale

  Evaluated QoL with Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire

  At the point of enrollment

• Quality of life (QoL), Depression-anxiety scale

  Evaluated QoL with Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire

  After 6 month of enrollment

• Quality of life (QoL), Depression-anxiety scale

  Evaluated QoL with Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire

  After 1 year of enrollment

• Quality of life (QoL), Depression-anxiety scale

  Evaluated QoL with Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire

  After 2 year of enrollment

Secondary Outcomes (2)

• Rate of patients who choose guideline-dependent surveillance rather than advanced imaging-dependent in SDM group

  6 month

• Cross over rate in SDM group

  2 years

Study Arms (2)

Shared decision making group

EXPERIMENTAL

The Study arm - shared decision making when deciding surveillance strategy

Diagnostic Test: Shared decision making

Usual surveillance group

OTHER

The control arm - surveillance with usual care

Diagnostic Test: Usual care

Interventions

Shared decision making 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"

Shared decision making group

Usual care DIAGNOSTIC_TEST

standard follow-up according to the institutional practice

Usual surveillance group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hyeong-Gon Moon

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, Clinical Professor

Study Record Dates

• First Submitted: April 18, 2021
• First Posted: April 27, 2021
• Study Start: July 6, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 8, 2024

Record last verified: 2024-07

Locations

KR (1)