Cancer
Conditions
Keywords
Questionnaires, telephone counseling session, 10-104, Childhood Cancer Survivor Women Post Chest Radiation
Brief 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. The EMPOWER Study has been designed for adult women who were treated for a childhood cancer with chest radiation.
Interventions
BEHAVIORALsurvey, questionaire
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.
Sponsors
Memorial Sloan Kettering Cancer Center
St. Jude Children's Research Hospital
University of Colorado, Denver
Dana-Farber Cancer Institute
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Diagnosed with breast cancer * Participated in the Project VISION feasibility study (exposed to part of the intervention)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| efficacy | 12 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Moderating factors | 12 months | 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. |
| Mediating factors | 12 months | 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. |
| Economic analysis | 12 months | 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 |
| Breast MRI completed by 12-month questionnaire | 12 months | (confirmed by medical record) • Barriers to completing breast MRI: moderating/mediating variables listed above |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChaya Moskowitz, PhD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed