Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

Breast Neoplasms Clinical Trial

Official title:

EMPOWER-II: Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03435380
• Other study ID #: Pro00088926
• Secondary ID: R01CA134722
• Status: Completed
• Phase: N/A
• Start date: May 7, 2019
• Est. completion date: February 27, 2023

Study information

• Verified date: September 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: February 27, 2023
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Early Detection of Cancer

Intervention

Behavioral:
• Patient activation
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.
• Primary care physician activation
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.
• Control
Mailed educational materials.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	Columbia University	New York	New York
United States	Hunter College, City of New York	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (7)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Activation Measure (PAM) - Questionnaire	Measures patient activation and includes: believing one has an active role to play, having the confidence and knowledge to take action, taking action, and staying the course under stress.	18 months
Other	Breast Cancer Surveillance Practices - Knowledge of Recommendations (Questionnaire)	The Breast Cancer Surveillance Practices instrument (questionnaire) was developed as part of an effort supported by NCI funding (R21CA106972) and published in JAMA (Oeffinger KC, et al. JAMA, 301:404-414, 2009). The section regarding knowledge of the recommendations was then adapted for the EMPOWER-I Study, supported by NCI R01134722, and includes 3 items to determine if participants have (1) heard of mammography for breast cancer screening (yes, no, not sure), at what age women like the participant should begin getting a mammogram, and how frequently (multiple time frames).	18 months
Other	Barrier Scales (Questionnaire)	Elicits a rank order of the most relevant and important barriers of breast MRI and those associated with mammogram, for those women who did not obtain the recommended screening. The barriers are presented as a list of 13 statements in which there are 5 ranges of measure provided for each statement. The scale ranges include "Not at all," "A little bit," "Moderately," "Quite a bit," and "Extremely." The value/response of "Not at all" is considered to be the better outcome, whereas the value/response of "Extremely" is considered to be the worst outcome for the barrier scale. The scale is not combined to compute a total score, since responses are scored for each statement individually.	18 months
Other	Pros and Cons of Mammography and Breast MRI (Questionnaire)	The Pros and Cons of mammography is a 13-item instrument developed by Rakowski et al (Prev Med 1997). It was used in our Breast Cancer Surveillance Practices instrument (Oeffinger KC, et al. JAMA, 2009). The pros and cons scores (5-point Likert items) are converted to T-scores and then presented as a summary Decisional Balance. For EMPOWER-I Study, we adapted this instrument to also assess a woman's perspective on the pros and cons of breast MRI. This resulted in a 7-item instrument that is analyzed similar to the Pros and Cons of Mammography and presented as a Decisional Balance.	18 months
Other	Family History of Breast Cancer (Questionnaire)	This one-item question asks participants whether their mother, sister(s), or daughter(s) have been diagnosed with breast cancer.	18 months
Other	Perception of Breast Cancer Risk (Questionnaire)	This item was developed for the aforementioned Breast Cancer Surveillance Practices instrument and is a one-time question with asking women how they estimate their risk of breast cancer (with five responses: much more than the average woman, more than the average woman, same as the average woman, less than the average woman, much less than the average woman).	18 months
Other	Communication With PCP (Questionnaire)	Developed for the EMPOWER-I study, the questionnaire asks participants at the end of the study whether they saw a health care provider during the 18-month study period, whether they discussed breast cancer screening with a provider, and whether the provider responded to the information (5-point Likert). Each of these items will be analyzed separately.	18 months
Other	Affect	Will be measured using the adapted and shortened version of the Positive Affect Negative Affect Scale (PANAS). We will focus on emotions related to managing health.	18 months
Other	Future Breast Screening Intentions	To determine the Stage of Adoption (Change) for breast cancer surveillance, participants will be asked when they plan to have their next mammogram and/or breast MRI (following the completion of the study).	18 months
Other	Self-Efficacy	Measures confidence in discussing breast surveillance with the primary care physician and obtaining the recommended screening using items developed by Champion and colleagues.	18 months
Other	Primary Care Provider Demographics	Age, gender, years in practice, and practice setting.	Baseline
Other	Primary Care Provider Experience	Most PCPs have taken care of only a few childhood cancer survivors. To ascertain their past experience with caring for this population, we ask PCPs how many childhood cancer survivors they have in their practice panel (0, 1-2, 3-5, >5).	18 months
Other	Primary Care Provider Comfort Level	Comfort level with caring for adult survivors of childhood cancer (Likert scale)and familiarity with available guidelines (Likert scale).	18 months
Other	Primary Care Provider Knowledge	Using a hypothetical vignette of a 29-year old female patient treated for Hodgkin lymphoma with chemotherapy and chest RT, questions will be asked about screening for thyroid dysfunction, breast cancer, and cardiac dysfunction.	18 months
Other	Economic Measurements	Replication costs of the intervention and health services from the intervention per participant.	18 months
Primary	Percentage of Women Who Completed a Breast MRI and Mammogram	Self-reported	18 months