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Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Sep 30, 2026 → Sep 30, 2028
See other at-risk trials from M.D. Anderson Cancer Center

Record History

  1. Primary and study completion pushed from Sep 30, 2026 to Sep 30, 2028 Primary endpoints: details revised at 1 of 3 entries · Eligibility criteria expanded, about 5 words Show 2 more changesShow less
    • Primary endpoints: details revised at 1 of 3 entries
    • Eligibility criteria expanded, about 5 words
  2. 4 versions Re-verified since Nov 7, 2024, no change to tracked fieldsv10-v13
  3. Primary and study completion dates: Sep 30, 2023 to Sep 30, 2026v9
  4. Re-verified, no change to tracked fieldsv8
  5. Primary and study completion dates: Sep 30, 2022 to Sep 30, 2023v7
Show 5 earlier versionsHide 5 earlier versions
  1. Primary and study completion dates: Sep 30, 2020 to Sep 30, 2022v6
  2. Primary and study completion dates: Apr 28, 2019 to Sep 30, 2020v5
  3. Enrollment target: 67 to 15 Primary endpoints: 1 to 3 · Primary and study completion dates: Apr 2019 to Apr 28, 2019 · Interventions: Questionnaires (Behavioral), Survey (Behavioral) to Decision Aid (Other), Questionnaire Administration (Other) · 6 morev4 Show 9 more changesShow less
    • Primary endpoints: 1 to 3
    • Primary and study completion dates: Apr 2019 to Apr 28, 2019
    • Interventions: Questionnaires (Behavioral), Survey (Behavioral) to Decision Aid (Other), Questionnaire Administration (Other)
    • Eligibility criteria revised
    • Study description shortened, about 285 words
    • Study site revised
    • Collaborator revised
    • Study title expanded, about 11 words
    • Study arms: 2 to 1

    See this version in full on ClinicalTrials.gov ↗

  4. Enrollment target: 10 to 67 Primary and study completion dates: Apr 2018 to Apr 2019 · Study description expanded, about 119 words · Eligibility criteria shortened, about 4 wordsv3 Show 3 more changesShow less
    • Primary and study completion dates: Apr 2018 to Apr 2019
    • Study description expanded, about 119 words
    • Eligibility criteria shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status: Not Yet Recruiting to Recruiting Start date: Dec 2016 to Apr 28, 2017 · Primary completion date: Dec 2017 to Apr 2018 · Completion date: Apr 2018 · 1 morev2 Show 4 more changesShow less
    • Start date: Dec 2016 to Apr 28, 2017
    • Primary completion date: Dec 2017 to Apr 2018
    • Completion date: Apr 2018
    • Site details revised
  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 the acceptability and how well decision making tool works in supporting decision making in contralateral prophylactic mastectomy in patients with newly diagnosed breast cancer. Decision making tool may help patients with early stage breast cancer make decisions regarding their surgical options.
Trial Details
NCT Number NCT02918474
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8 +15 more
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov