Breast NeoplasmsNCT03435380
Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer
A study testing Patient activation and Primary care physician activation in people with Breast Neoplasms and Early Detection of Cancer, run by Duke University at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Early Detection of Cancer
- What is being tested?
- Patient activation and Primary care physician activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 5 sitesUnited States
- Study dates
- 7 May 2019to 27 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
Show all 11Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Duke University Medical Center
Durham, North Carolina, 27710
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Columbia University
New York, New York, 10032
Hunter College, City of New York
New York, New York, 10065
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: EMPOWER-II: 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.
- Conditions
- Breast Neoplasms, Early Detection of Cancer
- Being tested
- Patient activation, Primary care physician activation, Control
- Keywords
- Cancer Survivors, Smartphone, Mobile Applications
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient activationBehavioural
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 activationBehavioural
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.
ControlBehavioural
Mailed educational materials.
| Study group | Role | What they receive |
|---|---|---|
| Control (C) | Experimental | Targeted mailed educational materials (C). Receives: Behavioral: Control |
| Patient activation (PA) | Experimental | 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. Receives: Behavioral: Patient activation; Behavioral: Control |
| Patient activation + primary care provider activation (PA+PCP) | Active comparator | 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. Receives: Behavioral: Patient activation; Behavioral: Primary care physician activation; Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Women Who Completed a Breast MRI and Mammogram
Self-reported
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start7 May 2019
- Primary completion31 Aug 2022
- Study completion27 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Kevin C Oeffinger, MD, Principal investigator, Duke UniversityJennifer S Ford, PhD, Principal investigator, City University of New York, School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435380
- Sponsor's protocol ID
- Pro00088926
- Other IDs
- R01CA134722
- Status last verified
- Sep 2023
- First submitted
- 1 Feb 2018
- Last updated
- 8 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants will be recruited from an established cohort (Childhood Cancer Survivor Study), and therefore individual participant data will not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMPOWER-II: Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer
- ClinicalTrials.gov ID
- NCT03435380
- Acronym / sponsor ID
- Pro00088926
- Conditions
- Breast Neoplasms, Early Detection of Cancer
- Keywords
- Cancer Survivors, Smartphone, Mobile Applications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- 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
- Study start
- 7 May 2019 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Posted 8 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control (C) | Experimental | Behavioral: ControlTargeted mailed educational materials (C). |
| Patient activation (PA) | Experimental | Behavioral: Patient activation, Behavioral: ControlC + 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 + primary care provider activation (PA+PCP) | Active comparator | Behavioral: Patient activation, Behavioral: Primary care physician activation, Behavioral: ControlC + 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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);
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient activationSmartphone-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. | Behavioural | Patient activation (PA), Patient activation + primary care provider activation (PA+PCP) |
| Primary care physician activationMailed 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. | Behavioural | Patient activation + primary care provider activation (PA+PCP) |
| ControlMailed educational materials. | Behavioural | Control (C), Patient activation (PA), Patient activation + primary care provider activation (PA+PCP) |
Primary outcome
Percentage of Women Who Completed a Breast MRI and Mammogram
Time frame: 18 months
Self-reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Participants will be recruited from an established cohort (Childhood Cancer Survivor Study), and therefore individual participant data will not be available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin C Oeffinger, MD principal investigator
Duke University
Jennifer S Ford, PhD principal investigator
City University of New York, School of Public Health
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient activation and Primary care physician activation in people with Breast Neoplasms and Early Detection of Cancer, run by Duke University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Women Who Completed a Breast MRI and Mammogram (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.