Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

Duke University

Status: Completed

Conditions: Early Detection of Cancer; Breast Neoplasms

Treatments: Behavioral: Control; Behavioral: Patient activation; Behavioral: Primary care physician activation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03435380

R01CA134722 (U.S. NIH Grant/Contract)

Pro00088926

Details and patient eligibility

About

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.

Enrollment: 314 patients

Sex: Female

Ages: 25+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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314 participants in 3 patient groups

Control (C)

Experimental group

Description:

Targeted mailed educational materials (C).

Treatment:

Behavioral: Control

Patient activation (PA)

Experimental group

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.

Treatment:

Behavioral: Patient activation

Behavioral: Control

Patient activation + primary care provider activation (PA+PCP)

Active Comparator group

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.

Treatment:

Behavioral: Primary care physician activation

Behavioral: Patient activation

Behavioral: Control