Breast Neoplasms, Early Detection of Cancer
Conditions
Keywords
Cancer Survivors, Smartphone, Mobile Applications
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.
Interventions
BEHAVIORALPatient 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.
BEHAVIORALPrimary 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.
BEHAVIORALControl
Mailed educational materials.
Sponsors
National Cancer Institute (NCI)
St. Jude Children's Research Hospital
Memorial Sloan Kettering Cancer Center
City University of New York, School of Public Health
University of California, San Francisco
Columbia University
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Women Who Completed a Breast MRI and Mammogram | 18 months | Self-reported |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Activation Measure (PAM) - Questionnaire | 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. |
| Breast Cancer Surveillance Practices - Knowledge of Recommendations (Questionnaire) | 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). |
| Barrier Scales (Questionnaire) | 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. |
| Pros and Cons of Mammography and Breast MRI (Questionnaire) | 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. |
| Family History of Breast Cancer (Questionnaire) | 18 months | This one-item question asks participants whether their mother, sister(s), or daughter(s) have been diagnosed with breast cancer. |
| Perception of Breast Cancer Risk (Questionnaire) | 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). |
| Communication With PCP (Questionnaire) | 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. |
| Economic Measurements | 18 months | Replication costs of the intervention and health services from the intervention per participant. |
| Future Breast Screening Intentions | 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). |
| Self-Efficacy | 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. |
| Primary Care Provider Demographics | Baseline | Age, gender, years in practice, and practice setting. |
| Primary Care Provider Experience | 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). |
| Primary Care Provider Comfort Level | 18 months | Comfort level with caring for adult survivors of childhood cancer (Likert scale)and familiarity with available guidelines (Likert scale). |
| Primary Care Provider Knowledge | 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. |
| Affect | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited in 12 waves from 5/7/2019 to 12/1/2020. The CCSS Coordinating Center sent introductory letters of invitation via email, regular mail, or phone. Interested participants were then given instructions on how to download the Eureka app from which they completed an electronic consent form and HIPAA waiver. All recruitment and study activities were completed remotely through the Eureka app.
Pre-assignment details
43 participants did not complete the baseline survey for varying reasons and were not randomized.
Participants by arm
| Arm | Count |
|---|---|
| Control (C) Targeted mailed educational materials (C).
Control: Mailed educational materials. | 90 |
| 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.
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.
Control: Mailed educational materials. | 91 |
| 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.
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. | 90 |
| Total | 271 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 1 | 2 | 1 |
| Overall Study | Ineligible | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 12 | 8 | 6 |
| Overall Study | Physician Decision | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Control (C) | Patient Activation (PA) | Patient Activation + Primary Care Provider Activation (PA+PCP) | Total |
|---|---|---|---|---|
| Age, Continuous | 42 years | 42 years | 42 years | 42 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 1 Participants | 7 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 83 Participants | 90 Participants | 79 Participants | 252 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 4 Participants | 7 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Asian or Other Pacific Islander | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Black or African American | 5 Participants | 3 Participants | 5 Participants | 13 Participants |
| Race/Ethnicity, Customized Race Other | 2 Participants | 1 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Race Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White | 80 Participants | 85 Participants | 81 Participants | 246 Participants |
| Region of Enrollment United States | 90 Participants | 91 Participants | 90 Participants | 271 Participants |
| Sex: Female, Male Female | 90 Participants | 91 Participants | 90 Participants | 271 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 90 | 2 / 91 | 1 / 90 |
| other Total, other adverse events | 0 / 90 | 0 / 91 | 0 / 90 |
| serious Total, serious adverse events | 0 / 90 | 0 / 91 | 0 / 90 |
Outcome results
Primary
Percentage of Women Who Completed a Breast MRI and Mammogram
Self-reported
Time frame: 18 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control (C) | Percentage of Women Who Completed a Breast MRI and Mammogram | 8.9 percentage of participants |
| Patient Activation (PA) | Percentage of Women Who Completed a Breast MRI and Mammogram | 22.0 percentage of participants |
| Patient Activation + Primary Care Provider Activation (PA+PCP) | Percentage of Women Who Completed a Breast MRI and Mammogram | 17.8 percentage of participants |
p-value: 0.01995% CI: [1.11, 5.07]Mantel Haenszel
p-value: 0.09295% CI: [0.87, 4.38]Mantel Haenszel
Other Pre-specified
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.
Time frame: 18 months
Other Pre-specified
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.
Time frame: 18 months
Other Pre-specified
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).
Time frame: 18 months
Other Pre-specified
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.
Time frame: 18 months
Other Pre-specified
Economic Measurements
Replication costs of the intervention and health services from the intervention per participant.
Time frame: 18 months
Other Pre-specified
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.
Time frame: 18 months
Other Pre-specified
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).
Time frame: 18 months
Other Pre-specified
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.
Time frame: 18 months
Other Pre-specified
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).
Time frame: 18 months
Other Pre-specified
Primary Care Provider Comfort Level
Comfort level with caring for adult survivors of childhood cancer (Likert scale)and familiarity with available guidelines (Likert scale).
Time frame: 18 months
Other Pre-specified
Primary Care Provider Demographics
Age, gender, years in practice, and practice setting.
Time frame: Baseline
Other Pre-specified
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).
Time frame: 18 months
Other Pre-specified
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.
Time frame: 18 months
Other Pre-specified
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.
Time frame: 18 months
Other Pre-specified
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.
Time frame: 18 months