Clinical trial NCT03435380: Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer
Official title: EMPOWER-II: Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Early Detection of Cancer
Keywords: Cancer Survivors
Smartphone
Mobile Applications
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: St. Jude Children's Research Hospital
name: Memorial Sloan Kettering Cancer Center
name: City University of New York, School of Public Health
name: University of California, San Francisco
name: Columbia University
First posted: 2018-02-19
Enrollment: 314
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned, in a ratio of 1:1:1, to one of the three groups: control, patient activation (PA), or patient activation + primary care provider activation (PA+PCP). Participants will remain in the group they are randomized to with no crossover throughout the study.
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Women Who Completed a Breast MRI and Mammogram
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
measure: Patient Activation Measure (PAM) - Questionnaire
timeFrame: 18 months
measure: Breast Cancer Surveillance Practices - Knowledge of Recommendations (Questionnaire)
timeFrame: 18 months
measure: Barrier Scales (Questionnaire)
timeFrame: 18 months
measure: Pros and Cons of Mammography and Breast MRI (Questionnaire)
timeFrame: 18 months
measure: Family History of Breast Cancer (Questionnaire)
timeFrame: 18 months
measure: Perception of Breast Cancer Risk (Questionnaire)
timeFrame: 18 months
measure: Communication With PCP (Questionnaire)
timeFrame: 18 months
measure: Affect
timeFrame: 18 months
measure: Future Breast Screening Intentions
timeFrame: 18 months
measure: Self-Efficacy
timeFrame: 18 months
measure: Primary Care Provider Demographics
timeFrame: Baseline
measure: Primary Care Provider Experience
timeFrame: 18 months
measure: Primary Care Provider Comfort Level
timeFrame: 18 months
measure: Primary Care Provider Knowledge
timeFrame: 18 months
measure: Economic Measurements
timeFrame: 18 months
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
city: New York
country: United States
facility: Hunter College, City of New York
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: Duke University
name: Kevin C Oeffinger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: City University of New York, School of Public Health
name: Jennifer S Ford, PhD
role: PRINCIPAL_INVESTIGATOR
References: