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NCT03435380 · OUTCOME

Percentage of Women Who Completed a Breast MRI and Mammogram

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.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
18 months

What was measured

Self-reported

Groups in this outcome

Control (C)

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

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.

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Control (C)90
Patient Activation (PA)91
Patient Activation + Primary Care Provider Activation (PA+PCP)90

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Control (C)8.9Not reported4.616.6Not reported
Patient Activation (PA)22.0Not reported14.731.5Not reported
Patient Activation + Primary Care Provider Activation (PA+PCP)17.8Not reported11.227.0Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    1.11
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.07
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.019
    param Type
    Risk Ratio (RR)
    param Value
    2.37
    statistical Comment
    Stratified by age at consent (25-39 vs \>=40), diagnosis (Hodgkin lymphoma vs other) and previous breast imaging exam (either mammogram or breast MRI).
    statistical Method
    Mantel Haenszel
  2. ci Lower Limit
    0.87
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.38
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.092
    param Type
    Risk Ratio (RR)
    param Value
    1.96
    statistical Comment
    Stratified by age at consent (25-39 vs \>=40), diagnosis (Hodgkin lymphoma vs other) and previous breast imaging exam (either mammogram or breast MRI).
    statistical Method
    Mantel Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    1.11
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.07
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.019
    param Type
    Risk Ratio (RR)
    param Value
    2.37
    statistical Comment
    Stratified by age at consent (25-39 vs \>=40), diagnosis (Hodgkin lymphoma vs other) and previous breast imaging exam (either mammogram or breast MRI).
    statistical Method
    Mantel Haenszel
  2. ci Lower Limit
    0.87
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.38
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.092
    param Type
    Risk Ratio (RR)
    param Value
    1.96
    statistical Comment
    Stratified by age at consent (25-39 vs \>=40), diagnosis (Hodgkin lymphoma vs other) and previous breast imaging exam (either mammogram or breast MRI).
    statistical Method
    Mantel Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.6
        upper Limit
        16.6
        value
        8.9
      2. group Id
        OG001
        lower Limit
        14.7
        upper Limit
        31.5
        value
        22.0
      3. group Id
        OG002
        lower Limit
        11.2
        upper Limit
        27.0
        value
        17.8
denoms
  1. counts
    1. group Id
      OG000
      value
      90
    2. group Id
      OG001
      value
      91
    3. group Id
      OG002
      value
      90
    units
    Participants
description
Self-reported
dispersion Type
95% Confidence Interval
groups
  1. description
    Targeted mailed educational materials (C). Control: Mailed educational materials.
    id
    OG000
    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
    OG001
    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
    OG002
    title
    Patient Activation + Primary Care Provider Activation (PA+PCP)
param Type
NUMBER
reporting Status
POSTED
time Frame
18 months
title
Percentage of Women Who Completed a Breast MRI and Mammogram
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice