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NCT03435380 · ADVERSE EVENTS

Adverse events

Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer · Source last updated 2023-09-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Up to 18 months
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Control (C)

Targeted mailed educational materials (C). Control: Mailed educational materials.

0 / 900 / 901 / 90
Patient Activation (PA)

C + patient activation (PA) consisting of (1) smartphone app with HIPAA compliant survivorship care plan that can be viewed, printed, or emailed to their primary care provider; and (2) two-way (interactive) tailored text messages with links to video vignettes discussing the primary barriers to breast MRI and mammography. Patient activation: Smartphone-based materials including text messages and supplemental short videos focusing on how to find a primary care doctor, the importance of medical screening, and how to talk to a doctor about medical screening. Guidelines for monitoring and maintaining health, such as a survivorship care plan, will also be included in the smartphone-based materials. Control: Mailed educational materials.

0 / 910 / 912 / 91
Patient Activation + Primary Care Provider Activation (PA+PCP)

C + PA + PCP activation (PA+PCP) with physician materials about breast cancer risk in this population along with national and international guidelines for breast cancer surveillance. Patient activation: Smartphone-based materials including text messages and supplemental short videos focusing on how to find a primary care doctor, the importance of medical screening, and how to talk to a doctor about medical screening. Guidelines for monitoring and maintaining health, such as a survivorship care plan, will also be included in the smartphone-based materials. Primary care physician activation: Mailed educational print materials sent to the participants' primary care doctors about health risks and recommendations for medical screening for adult women who were treated for a childhood cancer with chest radiation. Control: Mailed educational materials.

0 / 900 / 901 / 90

Group identifiers: EG000: Control (C) · EG001: Patient Activation (PA) · EG002: Patient Activation + Primary Care Provider Activation (PA+PCP)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

      Complete source fields
      event Groups
      1. deaths Num Affected
        1
        deaths Num At Risk
        90
        description
        Targeted mailed educational materials (C). Control: Mailed educational materials.
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        90
        serious Num Affected
        0
        serious Num At Risk
        90
        title
        Control (C)
      2. deaths Num Affected
        2
        deaths Num At Risk
        91
        description
        C + patient activation (PA) consisting of (1) smartphone app with HIPAA compliant survivorship care plan that can be viewed, printed, or emailed to their primary care provider; and (2) two-way (interactive) tailored text messages with links to video vignettes discussing the primary barriers to breast MRI and mammography. Patient activation: Smartphone-based materials including text messages and supplemental short videos focusing on how to find a primary care doctor, the importance of medical screening, and how to talk to a doctor about medical screening. Guidelines for monitoring and maintaining health, such as a survivorship care plan, will also be included in the smartphone-based materials. Control: Mailed educational materials.
        id
        EG001
        other Num Affected
        0
        other Num At Risk
        91
        serious Num Affected
        0
        serious Num At Risk
        91
        title
        Patient Activation (PA)
      3. deaths Num Affected
        1
        deaths Num At Risk
        90
        description
        C + PA + PCP activation (PA+PCP) with physician materials about breast cancer risk in this population along with national and international guidelines for breast cancer surveillance. Patient activation: Smartphone-based materials including text messages and supplemental short videos focusing on how to find a primary care doctor, the importance of medical screening, and how to talk to a doctor about medical screening. Guidelines for monitoring and maintaining health, such as a survivorship care plan, will also be included in the smartphone-based materials. Primary care physician activation: Mailed educational print materials sent to the participants' primary care doctors about health risks and recommendations for medical screening for adult women who were treated for a childhood cancer with chest radiation. Control: Mailed educational materials.
        id
        EG002
        other Num Affected
        0
        other Num At Risk
        90
        serious Num Affected
        0
        serious Num At Risk
        90
        title
        Patient Activation + Primary Care Provider Activation (PA+PCP)
      frequency Threshold
      0
      time Frame
      Up to 18 months

      Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

      Preserved source evidence · Not medical advice