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Completed

NCT Number: NCT03435380

Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

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.

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Key information

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Control

Behavioral

Mailed educational materials.

Primary outcomes

  1. Percentage of Women Who Completed a Breast MRI and Mammogram

    Time frame: 18 months

    Self-reported

Other outcomes

  1. Patient Activation Measure (PAM) - Questionnaire

    Time frame: 18 months

    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.

  2. Breast Cancer Surveillance Practices - Knowledge of Recommendations (Questionnaire)

    Time frame: 18 months

    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).

  3. Barrier Scales (Questionnaire)

    Time frame: 18 months

    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.

  4. Pros and Cons of Mammography and Breast MRI (Questionnaire)

    Time frame: 18 months

    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.

  5. Family History of Breast Cancer (Questionnaire)

    Time frame: 18 months

    This one-item question asks participants whether their mother, sister(s), or daughter(s) have been diagnosed with breast cancer.

  6. Perception of Breast Cancer Risk (Questionnaire)

    Time frame: 18 months

    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).

  7. Communication With PCP (Questionnaire)

    Time frame: 18 months

    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.

  8. Affect

    Time frame: 18 months

    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.

  9. Future Breast Screening Intentions

    Time frame: 18 months

    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).

  10. Self-Efficacy

    Time frame: 18 months

    Measures confidence in discussing breast surveillance with the primary care physician and obtaining the recommended screening using items developed by Champion and colleagues.

  11. Primary Care Provider Demographics

    Time frame: Baseline

    Age, gender, years in practice, and practice setting.

  12. Primary Care Provider Experience

    Time frame: 18 months

    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).

  13. Primary Care Provider Comfort Level

    Time frame: 18 months

    Comfort level with caring for adult survivors of childhood cancer (Likert scale)and familiarity with available guidelines (Likert scale).

  14. Primary Care Provider Knowledge

    Time frame: 18 months

    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.

  15. Economic Measurements

    Time frame: 18 months

    Replication costs of the intervention and health services from the intervention per participant.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Feb 19, 2018
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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