TriangleNCT03435380 · REGISTRY CONDITION SEARCH
Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- NA
- Status at capture
- COMPLETED
- Registry last update
- 2023-09-08
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Percentage of Women Who Completed a Breast MRI and Mammogram
Patient Activation Measure (PAM) - Questionnaire
Breast Cancer Surveillance Practices - Knowledge of Recommendations (Questionnaire)
Barrier Scales (Questionnaire)
Pros and Cons of Mammography and Breast MRI (Questionnaire)
Family History of Breast Cancer (Questionnaire)
Perception of Breast Cancer Risk (Questionnaire)
Communication With PCP (Questionnaire)
Affect
Future Breast Screening Intentions
Self-Efficacy
Primary Care Provider Demographics
Primary Care Provider Experience
Primary Care Provider Comfort Level
Primary Care Provider Knowledge
Economic Measurements
Adverse events
Limitations, agreements, and source contact
Who could take part
- 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.
- healthy Volunteers
- false
- minimum Age
- 25 Years
- sex
- FEMALE
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Targeted mailed educational materials (C).
- intervention Names
- Behavioral: Control
- label
- Control (C)
- type
- EXPERIMENTAL
- description
- 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.
- intervention Names
- Behavioral: Patient activation
- Behavioral: Control
- label
- Patient activation (PA)
- type
- EXPERIMENTAL
- description
- 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.
- intervention Names
- Behavioral: Patient activation
- Behavioral: Primary care physician activation
- Behavioral: Control
- label
- Patient activation + primary care provider activation (PA+PCP)
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Patient activation (PA)
- Patient activation + primary care provider activation (PA+PCP)
- description
- 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.
- name
- Patient activation
- type
- BEHAVIORAL
- arm Group Labels
- Patient activation + primary care provider activation (PA+PCP)
- description
- 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.
- name
- Primary care physician activation
- type
- BEHAVIORAL
- arm Group Labels
- Control (C)
- Patient activation (PA)
- Patient activation + primary care provider activation (PA+PCP)
- description
- Mailed educational materials.
- name
- Control
- type
- BEHAVIORAL
Study design
- 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.
- masking Info
- masking
- NONE
- primary Purpose
- PREVENTION
Enrollment
- count
- 314
- type
- ACTUAL
Registered outcome plans (not posted results)
- other Outcomes
- description
- 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.
- measure
- Patient Activation Measure (PAM) - Questionnaire
- time Frame
- 18 months
- description
- 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).
- measure
- Breast Cancer Surveillance Practices - Knowledge of Recommendations (Questionnaire)
- time Frame
- 18 months
- description
- 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.
- measure
- Barrier Scales (Questionnaire)
- time Frame
- 18 months
- description
- 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.
- measure
- Pros and Cons of Mammography and Breast MRI (Questionnaire)
- time Frame
- 18 months
- description
- This one-item question asks participants whether their mother, sister(s), or daughter(s) have been diagnosed with breast cancer.
- measure
- Family History of Breast Cancer (Questionnaire)
- time Frame
- 18 months
- description
- 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).
- measure
- Perception of Breast Cancer Risk (Questionnaire)
- time Frame
- 18 months
- description
- 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.
- measure
- Communication With PCP (Questionnaire)
- time Frame
- 18 months
- description
- 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.
- measure
- Affect
- time Frame
- 18 months
- description
- 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).
- measure
- Future Breast Screening Intentions
- time Frame
- 18 months
- description
- Measures confidence in discussing breast surveillance with the primary care physician and obtaining the recommended screening using items developed by Champion and colleagues.
- measure
- Self-Efficacy
- time Frame
- 18 months
- description
- Age, gender, years in practice, and practice setting.
- measure
- Primary Care Provider Demographics
- time Frame
- Baseline
- description
- 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).
- measure
- Primary Care Provider Experience
- time Frame
- 18 months
- primary Outcomes
- description
- Self-reported
- measure
- Percentage of Women Who Completed a Breast MRI and Mammogram
- time Frame
- 18 months
Full study description
- 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.
Source references
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice