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Patient Activation with or without Primary Care Provider Activation in Promoting Breast Cancer Screening in Childhood Cancer Survivors Previously Treated with Chest Radiation Therapy

Trial Status: Active

This phase III trial studies patient and primary care provider activation to see how well it works compared with patient activation alone in promoting breast cancer screening in childhood cancer survivors previously treated with chest radiation therapy. Patient and primary care provider activation may encourage screening and early detection of breast cancer, with the potential to improve the health and quality of life of female childhood cancer survivors.

Inclusion Criteria

  • Participants in the Childhood Cancer Survivor Study (CCSS)
  • Were diagnosed with a childhood cancer prior to the age of 21 years
  • Were treated with >= 10 Gy of chest radiation therapy (RT) (recent revision with a lower dose threshold)
  • Do not have a history of breast cancer
  • Have not had both a breast MRI and mammogram in the previous 24 months
  • Do not have a contraindication to MRI (i.e., pacemaker)
  • Have an interval from their chest RT to the time of enrollment of at least 8 years
  • Have a smartphone
  • Are English-speaking

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Jennifer Ford

North Carolina

Durham
Duke University Medical Center
Status: ACTIVE
Contact: Kevin Charles Oeffinger
Phone: 919-668-2122

Tennessee

Memphis
Saint Jude Children's Research Hospital
Status: ACTIVE
Contact: Todd Gibson

PRIMARY OBJECTIVES:

I. To determine the effectiveness of: (1) a smartphone-based patient activation (PA) intervention and (2) primary care provider (PCP) activation added to patient activation (PA + PCP), compared to control (C) participants receiving the EMPOWER-I intervention targeted mailed materials, on completing a breast magnetic resonance imaging (MRI) and mammogram.

II. To determine the effectiveness of PA + PCP compared to PA on breast cancer surveillance rates (breast MRI + mammogram).

III. To determine the effectiveness of the two interventions on rates of each individual surveillance test: breast MRI or mammography.

IV. To explore moderating and mediating patient and PCP-level factors (from baseline and 12-month surveys of participants and their PCPs) that predict breast MRI and mammography completion and timing of the obtained surveillance.

V. To estimate (1) the replication costs of the interventions and (2) costs resulting from the interventions.

VI a. Annotate the repository with sociodemographics of the women, radiation dose/field, and measures of ovarian function, and imaging modality.

VI b. Utilize the Mazurowski method of deep learning-based segmentation for normalization of the breast MRIs.

VII. Characterize mammographic breast density, by single-reader radiology review and by semi-manual, semi-automated computer software (Cumulus), in childhood cancer survivors using the breast imaging repository and compare to the mammographic breast density in a cohort of women without a history of cancer and undergoing routine breast mammography, matched 1:3 for age at study, calendar year of mammogram, race/ethnicity, and menopausal status.

VIII. Measure background parenchymal enhancement (BPE) on breast MRIs, by single-reader radiology review and by computer-based algorithm, in the repository and compare to a cohort of high-risk women without a prior cancer who are undergoing breast cancer screening with breast MRI; match 1:2 for age at study, calendar year of breast MRI, race/ethnicity, and menopausal status.

OUTLINE: Patients are randomized to 1 of 3 groups.

GROUP I: Patients receive targeted mailed educational materials describing the potential benefits and other considerations of breast cancer screening, including a survivorship care plan.

GROUP II: Patients receive targeted mailed educational materials describing the potential benefits and other considerations of breast cancer screening, including a survivorship care plan. Patients also receive PA intervention consisting of smartphone-based materials including tailored push notifications and application (app) messages with supplemental short videos focusing on how to find a primary care doctor, the importance of medical screening, and how to talk to doctors about medical screening. Guidelines for monitoring and maintaining health, such as a survivorship care plan, will also be included in the smartphone-based materials.

GROUP III: Patients receive targeted mailed educational materials describing the potential benefits and other considerations of breast cancer screening, including a survivorship care plan. Patients also receive PA intervention as in Group II and PCP activation intervention consisting of faxed educational materials sent to PCP about health risks and recommendations for medical screening for adult women who were treated for a childhood cancer with chest radiation.

After completion of study, patients are followed up at 12 months.

Trial Phase Phase III

Trial Type Screening

Lead Organization
Duke University Medical Center

Principal Investigator
Kevin Charles Oeffinger

  • Primary ID Pro00088926
  • Secondary IDs NCI-2018-00346
  • Clinicaltrials.gov ID NCT03435380