Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

Not Applicable

Completed

• Conditions: Early Detection of Cancer; Breast Neoplasms
• Interventions: Behavioral: Control; Behavioral: Patient activation; Behavioral: Primary care physician activation

• Registration Number: NCT03435380
• Lead Sponsor: Duke University

Brief Summary

The primary purpose of this study is to determine the impact of maximizing patient and primary care provider (PCP) activation on breast cancer surveillance rates among women previously treated with chest radiotherapy (RT) for a childhood cancer. This is an 18-month, 3-arm randomized controlled trial using a smartphone intervention with data being collected at baseline and 18-months through patient and provider surveys and medical record review. Eligible women treated for a childhood cancer with chest RT will be randomly sampled from the Childhood Cancer Survivor Study (CCSS) and randomly selected to one of three groups: control, patient activation (PA) using a smartphone-based intervention, or patient activation + primary care provider activation (PA+PCP) which will include physician materials about breast cancer risk in this population along with guidelines for breast cancer surveillance. Participants in all groups will receive mailed targeted print materials as an educational resource about their previous chest radiation and breast cancer screening recommendations. The primary outcome is a medical record confirmed breast MRI and mammogram with the goal of increasing the rate of women completing the national guideline-based recommended combination of breast MRI and mammogram. This study will test the hypothesis that women in the PA and PA+PCP groups will have significantly higher rates of breast cancer surveillance (breast MRI and mammogram) than women in the control group. In addition, the hypothesis that women in the PA+PCP group will have significantly higher rates of breast cancer surveillance than women in the PA group will also be tested.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-01
• Study First Submitted QC: 2018-02-09
• Study First Posted: 2018-02-19
• Study Start: 2019-05-07
• Primary Completion: 2022-08-31
• Study Completion: 2023-02-27
• Results First Submitted: 2023-08-08
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-06
• Last Update Submitted: 2023-09-06
• Results First Posted: 2023-09-08
• Last Update Posted: 2023-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 314

Inclusion Criteria

Eligible participants will include women who:

• Were diagnosed with a childhood cancer prior to the age of 21 years;
• Were treated with ≥ 10 Gy of chest RT (recent revision with a lower dose threshold);1
• 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);
• Are 25 years of age or older at time of enrollment;
• Have an interval from their chest RT to the time of enrollment of at least 8 years;
• Have a smartphone;
• Are English-speaking.

Participants will be selected from women in the Childhood cancer Survivor Study (CCSS) cohort.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control (C)	Control	Targeted mailed educational materials (C).
Patient activation (PA)	Patient activation	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 + primary care provider activation (PA+PCP)	Patient activation	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 (PA)	Control	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 + primary care provider activation (PA+PCP)	Primary care physician activation	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 + primary care provider activation (PA+PCP)	Control	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Women Who Completed a Breast MRI and Mammogram	18 months	Self-reported

Trial Locations

Locations (5)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Hunter College, City of New York; 🇺🇸 New York, New York, United States

Columbia University; 🇺🇸 New York, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States