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NCT03435380 · FLOW

Participant flow

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.

groups
  1. description
    Targeted mailed educational materials (C). Control: Mailed educational materials.
    id
    FG000
    title
    Control (C)
  2. 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
    FG001
    title
    Patient Activation (PA)
  3. 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
    FG002
    title
    Patient Activation + Primary Care Provider Activation (PA+PCP)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        6
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Ineligible
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        90
      2. group Id
        FG001
        num Subjects
        91
      3. group Id
        FG002
        num Subjects
        90
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        76
      2. group Id
        FG001
        num Subjects
        79
      3. group Id
        FG002
        num Subjects
        81
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        9
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
43 participants did not complete the baseline survey for varying reasons and were not randomized.
recruitment Details
Participants were recruited in 12 waves from 5/7/2019 to 12/1/2020. The CCSS Coordinating Center sent introductory letters of invitation via email, regular mail, or phone. Interested participants were then given instructions on how to download the Eureka app from which they completed an electronic consent form and HIPAA waiver. All recruitment and study activities were completed remotely through the Eureka app.
Complete source fields
groups
  1. description
    Targeted mailed educational materials (C). Control: Mailed educational materials.
    id
    FG000
    title
    Control (C)
  2. 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
    FG001
    title
    Patient Activation (PA)
  3. 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
    FG002
    title
    Patient Activation + Primary Care Provider Activation (PA+PCP)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        6
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Ineligible
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        90
      2. group Id
        FG001
        num Subjects
        91
      3. group Id
        FG002
        num Subjects
        90
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        76
      2. group Id
        FG001
        num Subjects
        79
      3. group Id
        FG002
        num Subjects
        81
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        9
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
43 participants did not complete the baseline survey for varying reasons and were not randomized.
recruitment Details
Participants were recruited in 12 waves from 5/7/2019 to 12/1/2020. The CCSS Coordinating Center sent introductory letters of invitation via email, regular mail, or phone. Interested participants were then given instructions on how to download the Eureka app from which they completed an electronic consent form and HIPAA waiver. All recruitment and study activities were completed remotely through the Eureka app.

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

Preserved source evidence · Not medical advice