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CancerPhase 3NCT01579552

Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

A Phase 3 study testing survey, questionaire in people with Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to empower women to improve their health in two very important areas: breast and heart health. This twelve-month study will compare two methods of informing participants about potential health risks and ways to stay healthy. Read more about this study

Who is it for?
Ages 25 to 49 years, women only
Conditions the study is for
Cancer
What is being tested?
survey, questionaire
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
2 sitesUnited States
Study dates
Jul 2010to Jul 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 to 49 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Participant in the CCSS cohort
  • Diagnosed with a childhood cancer prior to 21 years of age
  • Treated with > 20 Gy of chest radiation (mantle, mediastinal, lung, or chest)
  • Age 25-49 years at time of enrollment into the study
  • Interval from chest radiation to the time of enrollment of > 8 years
  • No mammogram or other breast imaging study in the 24 months prior to enrollment
  • English-speaking - The University of Colorado AMC Denver and MSKCC group are not capable of or equipped for conducting a brief motivational interviews by telephone in another language.

Who cannot join

  • Diagnosed with breast cancer
  • Participated in the Project VISION feasibility study (exposed to part of the intervention)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • St. Jude Children's Research Hospital

    Memphis, Tennessee

  • Memorial Sloan Kettering Cancer Center (All protocol activities)

    New York, New York, 10021

Other trials in United States

About this study

Official title: EMPOWER Study: Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

The purpose of this study is to empower women to improve their health in two very important areas: breast and heart health. This twelve-month study will compare two methods of informing participants about potential health risks and ways to stay healthy.

The EMPOWER Study has been designed for adult women who were treated for a childhood cancer with chest radiation.

Conditions
Cancer
Being tested
survey, questionaire
Keywords
Questionnaires, telephone counseling session, 10-104, Childhood Cancer Survivor Women Post Chest Radiation
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • survey, questionaireBehavioural

    The intervention components (mailed tailored print materials followed by telephone-delivered Brief MI). Following enrollment into the study and completion of the informed consent form and baseline survey, participants will be randomized to the active intervention group or the attention control group. The data that will be used in the analysis will come from the baseline survey, medical records of breast imaging studies, and a 12-month follow-up questionnaire.

  • survey, questionaireBehavioural

    The intervention components (mailed tailored print materials followed by telephone-delivered Brief MI). Following enrollment into the study and completion of the informed consent form and baseline survey, participants will be randomized to the active intervention group or the attention control group. The data that will be used in the analysis will come from the baseline survey, medical records of breast imaging studies, and a 12-month follow-up questionnaire.

Study groups in NCT01579552
Study groupRoleWhat they receive
Intervention GroupExperimentalThe EMPOWER intervention trial is a 12-month study of 360 women from the Childhood Cancer Survivor Study who have previously been treated with chest radiation, are 25 to 49 years of age at the time of enrollment, are 8 years or more since their chest radiation, and have not had a mammogram or other breast imaging study in the preceding two years. Following a baseline questionnaire, participants will be randomized to the attention control group (N=120) or the intervention group (N=240).
Receives: Behavioral: survey, questionaire
attention control groupActive comparatorThe EMPOWER intervention trial is a 12-month study of 360 women from the Childhood Cancer Survivor Study who have previously been treated with chest radiation, are 25 to 49 years of age at the time of enrollment, are 8 years or more since their chest radiation, and have not had a mammogram or other breast imaging study in the preceding two years. Following a baseline questionnaire, participants will be randomized to the attention control group (N=120) or the intervention group (N=240).
Receives: Behavioral: survey, questionaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. efficacy

    Determine the efficacy of an intervention, consisting of mailed tailored print materials followed by a telephone-delivered Brief Motivational Interview, on mammogram screening rates compared with an attention control. Mammogram completed by 12-month questionnaire (confirmed by medical record)

    Measured: 12 months

Secondary outcomes (4)

  1. Moderating factors

    By including interaction terms in the model, we will assess potential moderating factors such as age, race/ethnicity, health insurance, \& other sociodemographic variables. Moderating effects can be adequately addressed through interactions between the intervention \& the above mentioned covariates.124 An interaction with the treatment group indicator suggests differential effectiveness, and moderator variables with statistically significant interactions will remain in the model. Interactions will be estimated using crossproduct terms between the intervention indicator \& the mediating variable.

    Measured: 12 months

  2. Mediating factors

    Based on results from the MPS \& breast ca screening intervention trials among women in the general pop or familial risk, we are a priori interested in mediating effect of 5 variable domains: knowledge of screening guidelines, breast ca health beliefs, decisional balance of the pros \& cons of mammography, self-efficacy, \& psychological factors. For each of these domains, a global or subscale score will be used as appropriate. For ex, from the BSI-18, a global score of psychological symptoms \& a subscale score for each group of symptoms can be estimated.

    Measured: 12 months

  3. Economic analysis

    Replication costs of intervention: dollar cost; time cost (per person)

    • Costs resulting from intervention: total cost of screening/diagnostic imaging, diagnostic procedures, breast surgery, non-procedure breast-related physician visits

    Measured: 12 months

  4. Breast MRI completed by 12-month questionnaire

    (confirmed by medical record)

    • Barriers to completing breast MRI: moderating/mediating variables listed above

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2012 (estimated)
  2. Study startJul 2010
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01579552
Sponsor's protocol ID
10-104
Status last verified
Aug 2026
First submitted
3 Apr 2012
Last updated
5 Aug 2026
Results posted
No

Publications

  • Oeffinger KC, Ford JS, Moskowitz CS, Chou JF, Henderson TO, Hudson MM, Diller L, McDonald A, Ford J, Mubdi NZ, Rinehart D, Vukadinovich C, Gibson TM, Anderson N, Elkin EB, Garrett K, Rebull M, Leisenring W, Robison LL, Armstrong GT. Promoting Breast Cancer Surveillance: The EMPOWER Study, a Randomized Clinical Trial in the Childhood Cancer Survivor Study. J Clin Oncol. 2019 Aug 20;37(24):2131-2140. doi: 10.1200/JCO.19.00547. Epub 2019 Jul 1.

    PubMed 31260642

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing survey, questionaire in people with Cancer, run by Memorial Sloan Kettering Cancer Center at 2 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 7 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

efficacy (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01579552, which also lists 1 linked publication.

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 5 Aug 2026.

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