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Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

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ClinicalTrials.gov Identifier: NCT03435380
Recruitment Status : Not yet recruiting
First Posted : February 16, 2018
Last Update Posted : April 26, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
St. Jude Children's Research Hospital
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Duke University

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 a 12-month, 3-arm randomized controlled trial using a smartphone intervention with data being collected at baseline and 12-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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Early Detection of Cancer Behavioral: Patient activation Behavioral: Primary care physician activation Behavioral: Control Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 291 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: EMPOWER-II: Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Control (C)
Targeted mailed educational materials (C).
Behavioral: Control
Mailed educational materials.

Experimental: Patient activation (PA)
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
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.

Behavioral: Control
Mailed educational materials.

Active Comparator: Patient activation + primary care provider activation (PA+PCP)
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
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.

Behavioral: 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.

Behavioral: Control
Mailed educational materials.




Primary Outcome Measures :
  1. Number of women who completed a breast MRI and mammogram [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Patient Activation Measure (PAM) - questionnaire [ Time Frame: 12 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: 12 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: 12 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: 12 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: 12 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: 12 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: 12 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 12-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: 12 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: 12 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: 12 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: 12 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: 12 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: 12 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: 12 months ]
    Replication costs of the intervention and health services from the intervention per participant.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435380


Contacts
Contact: Kevin C Oeffinger, MD 919-668-2122 kevin.oeffinger@duke.edu
Contact: Jennifer S Ford, PhD 646-888-0042 fordj@mskcc.org

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
Contact: Jennifer S Ford, PhD    646-888-0042    fordj@mskcc.org   
United States, North Carolina
Duke University Medical Center Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Kevin C Oeffinger, MD    919-668-2122    kevin.oeffinger@duke.edu   
United States, Tennessee
St. Jude Children's Research Hospital Not yet recruiting
Memphis, Tennessee, United States, 38105
Contact: Gregory T Armstrong, MD, MSCE    901-595-5892    greg.armstrong@stjude.org   
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
St. Jude Children's Research Hospital
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Kevin C Oeffinger, MD Duke University
Principal Investigator: Jennifer S Ford, PhD Memorial Sloan Kettering Cancer Center

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03435380     History of Changes
Other Study ID Numbers: Pro00088926
R01CA134722 ( U.S. NIH Grant/Contract )
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Participants will be recruited from an established cohort (Childhood Cancer Survivor Study), and therefore individual participant data will not be available to other researchers.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:
Cancer Survivors
Smartphone
Mobile Applications

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases