Increasing Patients' Engagement in Breast Cancer Surgery Decision-Making

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Trial completed
    • Study completion date changed from estimate of Dec 15, 2026 to May 30, 2023
  2. Eligibility criteria expanded, about 8 words
    • Secondary endpoints revised (2)
    • Site details revised at 8 of 58 sites
    • Publications: details revised at 5 of 5 entries
  3. Re-verified, no change to tracked fieldsv29
  4. Study completion date: Dec 15, 2024 to Dec 15, 2026v28
  5. Results first posted: Aug 27, 2024v27 Show 5 more changesShow less
    • Start date: Mar 1, 2019 to Jun 5, 2019
    • Enrollment target: 598 to 627
    • Study completion date: Dec 15, 2023 to Dec 15, 2024
    • Secondary endpoints revised (2)
    • Primary endpoints revised (2)
Show 25 earlier versionsHide 25 earlier versions
  1. Primary completion date changed from estimate of Dec 15, 2023 to Jan 26, 2023v26
  2. Primary and study completion dates: Dec 15, 2022 to Dec 15, 2023v25
  3. Re-verified, no change to tracked fieldsv24
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 1050 to confirmed 598
    • Site details revised at 58 of 58 sites
    v23
  5. Primary completion date: Dec 2021 to Dec 15, 2022
    • Study completion date: Dec 2022 to Dec 15, 2022
    v22
  6. Site details revised at 1 of 58 sitesv21
  7. Site details revised at 2 of 58 sitesv20
  8. Site contacts updated at 1 of 58 sitesv19
  9. Study sites revised (58)v18
  10. Site details revised at 32 of 58 sitesv17
  11. Study sites revised (58)v16
  12. Primary completion date: Dec 2020 to Dec 2021
    • Site details revised at 17 of 58 sites
    v15
  13. Study sites: 56 to 58v14
  14. Re-verified, no change to tracked fieldsv13
  15. Trial status: Suspended to Recruiting
    • Study sites: 55 to 56
    v12
  16. Trial status: Recruiting to Suspended Sponsor's reason: COVID-19
    • Study sites revised (55)
    v11
  17. Site details revised at 16 of 55 sitesv10
  18. Re-verified, no change to tracked fieldsv9
  19. Site contacts updated at 2 of 55 sitesv8
  20. Study sites: 53 to 55v7
  21. Study sites: 52 to 53v6
  22. Study sites: 46 to 52v5
  23. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 46
    • Start date changed from estimate of Mar 2019 to Mar 1, 2019
    • Collaborators: 1 to 2
    v4
  24. Start date: Dec 2018 to Mar 2019v3
  25. Interventions: Consultation (Other), Informational Intervention (Other), Internet-Based Intervention (Other), Interview (Other), Interview (Other) to Usual Care (Other), Web-based decision aid (Other)
    • Secondary endpoints revised (2)
    • Study title shortened, about 11 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This trial studies how well a breast cancer surgery decision aid works in increasing patient engagement in decision making for patients with newly diagnosed stage 0-III breast cancer. The trial also examines barriers to patient engagement even with the use of a decision aid, and if barriers are more likely to be experienced by socioeconomically disadvantaged patients.
Trial Details
NCT Number NCT03766009
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI), Agency for Healthcare Research and Quality (AHRQ)
Conditions
(from sponsor)		 Breast Cancer Stage 0, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
Related terms Breast Carcinoma In Situ, Breast Neoplasms
Enrollment 627 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov