NCT03435380

Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

Completed NA Results posted Last updated 8 September 2023

What this trial tests

NA trial testing Patient activation in Breast Neoplasms in 314 participants. Completed in 27 February 2023.

Timeline

7 May 2019

Primary endpoint
31 August 2022

27 February 2023

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	314
Start date	7 May 2019
Primary completion	31 August 2022
Estimated completion	27 February 2023
Sites	5 locations across United States

Drugs / interventions tested

• Patient activation
• Primary care physician activation
• Control

Conditions studied

• Breast Neoplasms — all drugs for Breast Neoplasms →
• Early Detection of Cancer — all drugs for Early Detection of Cancer →

Sponsor

Duke University

Who can join

25 and older, female only, with Breast Neoplasms or Early Detection of Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Women Who Completed a Breast MRI and Mammogram Primary · 18 months

Self-reported

Group	Value	95% CI
Control (C)	8.9	4.6 – 16.6
Patient Activation (PA)	22.0	14.7 – 31.5
Patient Activation + Primary Care Provider Activation (PA+PCP)	17.8	11.2 – 27.0

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Adherence to Surveillance for Second Malignant Neoplasms and Cardiac Dysfunction in Childhood Cancer Survivors: A Childhood Cancer Survivor Study.
   Yan AP, Chen Y, Henderson TO, Oeffinger KC, et al · · 2020 · cited 45× · PMID 32142393 · DOI 10.1200/jco.19.01825
2. Current and coming challenges in the management of the survivorship population.
   Chow EJ, Ness KK, Armstrong GT, Bhakta N, et al · · 2020 · cited 31× · PMID 32197774 · DOI 10.1053/j.seminoncol.2020.02.007