Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

NCT03435380 | Completed Results DMC

• 2 other identifiers: Pro00088926R01CA134722
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 5

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.

Conditions

Breast Neoplasms; Early Detection of Cancer

Keywords

Cancer Survivors; Smartphone; Mobile Applications

Outcome Measures

Primary Outcomes (1)

• Percentage of Women Who Completed a Breast MRI and Mammogram

  Self-reported

  18 months

Other Outcomes (15)

• Patient Activation Measure (PAM) - Questionnaire

  18 months

• Breast Cancer Surveillance Practices - Knowledge of Recommendations (Questionnaire)

  18 months

• Barrier Scales (Questionnaire)

  18 months

Study Arms (3)

Control (C)

EXPERIMENTAL

Targeted mailed educational materials (C).

Behavioral: Control

Patient activation (PA)

EXPERIMENTAL

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.

Behavioral: Patient activation; Behavioral: Control

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

ACTIVE COMPARATOR

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.

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

Interventions

Patient activation BEHAVIORAL

Smartphone-based materials including text messages and supplemental short videos focusing on how to find a primary care doctor, the importance of medical screening, and how to talk to a doctor about medical screening. Guidelines for monitoring and maintaining health, such as a survivorship care plan, will also be included in the smartphone-based materials.

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

Primary care physician activation BEHAVIORAL

Mailed educational print materials sent to the participants' primary care doctors about health risks and recommendations for medical screening for adult women who were treated for a childhood cancer with chest radiation.

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

Control BEHAVIORAL

Mailed educational materials.

Control (C); Patient activation (PA); Patient activation + primary care provider activation (PA+PCP)

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator
• St. Jude Children's Research Hospital: collaborator
• Memorial Sloan Kettering Cancer Center: collaborator
• City University of New York, School of Public Health: collaborator
• University of California, San Francisco: collaborator
• Columbia University: collaborator

Study Sites (5)

Columbia University

New York, New York, 10032, United States

Location

Hunter College, City of New York

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Kevin Oeffinger, MD
• Organization: Duke University

kevin.oeffinger@duke.edu

919-668-2122

Study Officials

• Kevin C Oeffinger, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Jennifer S Ford, PhD

  City University of New York, School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 19, 2018
• Study Start: May 7, 2019
• Primary Completion: August 31, 2022
• Study Completion: February 27, 2023
• Last Updated: September 8, 2023
• Results First Posted: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)