A Research Study for Latina Women After Breast Cancer Treatment

Among Hispanics, the largest and fastest growing ethnic minority group in the U.S., cancer is
the leading cause of death whereas cardiovascular disease is the leading cause of death for
African Americans and non-Hispanic Whites (NHWs). Hispanics also experience substantially
lower rates of 5-year cancer-specific survival relative to non-Hispanic Whites (NHWs).
Hispanic cancer patients in the U.S. also report significantly worse cancer-related symptom
burden and health-related quality of life (HRQOL) than NHWs, even after adjusting for
socioeconomic factors. Despite this, very few randomized, intervention studies have
specifically targeted cancer-related symptom burden and HRQOL outcomes among Hispanic women,
especially during the period at the end of active treatment which is a critical period to
intervene to provide skills and tools to assist with this transition. Innovative approaches
to providing interventions such as Smartphone technology are especially important for this
patient population. Ubiquitous Smartphone use among ethnic minorities in the US provide a
unique opportunity to implement a pragmatic technology- and evidence-based psychosocial
intervention that overcomes some access to care barriers as well as time and logistical
constraints. Furthermore, given that Hispanics own Smartphones and seek health information
online from a mobile device at similar or higher rates than other groups in the U.S.,
Smartphone interventions offer an opportunity to overcome obstacles to accessing resources
and services that can be culturally informed and provide skills to improve symptom burden and
HRQOL. This study aims to create and evaluate a culturally informed eHealth psychoeducational
and psychosocial intervention for English or Spanish-speaking Hispanic women completing
treatment for breast cancer. This intervention is grounded in evidence-based paradigms to
improve the proposed Primary Outcomes: Cancer-Related Symptom Burden and HRQOL and the
proposed Secondary Outcomes: usability and markers the intervention use. This study is
designed in two-phases to develop and test a Smartphone-based intervention that can be
disseminated to cancer survivors at a relatively low cost. The first phase is intended to
create an eHealth intervention designed to improve cancer-related symptom burden and HRQOL.
The second phase is designed as an 8-week randomized trial intended to evaluate the eHealth
intervention when compared to a control condition. It is hypothesized that the eHealth
intervention will significantly improve cancer-related symptom burden and HRQOL compared to
the control condition.

Inclusion Criteria:

1. Female

2. Diagnosis of breast cancer, non-metastatic, stage 0-IIIA; for women diagnosed with
stage 0, either radiation or chemotherapy is required as an additional treatment to
surgery

3. Completed active treatment for breast cancer (surgery, chemotherapy and/or radiation
therapy, current hormonal treatment allowed)

4. No current evidence of disease

5. Within 3 to 24 months post-active treatment [e.g., surgery, chemotherapy, radiation,
or combination of the two or three]

6. at least 21 years of age

7. Able to speak and read English or Spanish

8. Able to provide informed consent

9. Elevated score on breast cancer symptom burden and HRQoL, measured by the Functional
Assessment of Cancer Therapy-Breast using an established cut-off score for clinically
meaningful, compromised HRQoL

10. Self-identified Hispanic/Latina ethnicity.

Exclusion Criteria:

1. Visual, hearing, voice, or motor impairment that would prevent completion of study
procedures

2. diagnosis of an unmanaged psychotic disorder, bipolar disorder, dissociative disorder,
or other diagnosis for which participation in this trial is either inappropriate or
dangerous - this includes patients who have life-threatening illness (e.g., end-stage
kidney disease) or diagnosis of a chronic disease that is associated with a major
functional impairment (e.g., fibromyalgia)

3. Illicit substance or alcohol dependence

4. Suicidal ideation, plan, intent

5. Alzheimer's, dementia or history of stroke

6. Scheduled reconstruction surgery within 1 month of any study procedures or
involvement.