Predictors of Adjuvant Endocrine Therapy in Women With Breast Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 5/10/2018 |
| Start Date: | April 2011 |
| End Date: | April 2019 |
Breast cancer is the leading cancer diagnosed in women and the second cause of cancer death.
Of all racial/ethnic groups in the US, Black women have the highest rate of breast cancer
deaths. Two-thirds of Black breast cancer patients have estrogen receptor (ER) positive
tumors that can be treated with adjuvant hormonal therapy. If taken for the full five years,
this therapy has been shown to reduce mortality by 50%. However, ER positive Black women are
more likely to die from their breast cancer as ER positive White women. Preliminary data
suggest that non-adherence to adjuvant hormonal therapy could explain some of this disparity.
To date, no study has systematically examined psychosocial, healthcare, and biological
factors that predict adherence to hormonal therapy in Black women with breast cancer. To
begin to fill this knowledge gap, Investigators will conduct a prospective cohort study of
422 ER positive Black breast cancer patients recruited from health maintenance organizations
(HMOs). Our primary outcome is adherence to therapy at 36 months post initiation. Specific
aims are to: 1) Examine psychosocial factors (e.g. health beliefs, socio-cultural values,
etc.) that predict adherence to hormonal therapy; 2) Identify clinical (e.g., side effects),
and biological (e.g., stage, etc.) factors that predict adherence to hormonal therapy; and 3)
Evaluate healthcare variables (e.g., communication, management of side effects, etc.) that
predict adherence. Investigators will also explore the role of CYP2D6 genetic variations in
adherence to hormonal therapy which is novel and will increase knowledge about this genetic
factor in Blacks. The study is focused on the time-period (first 3 years) when women appear
to be the most vulnerable to terminating treatment prematurely. A better understanding of
predictors of adherence in Black women may help target interventions and ultimately improve
potentially avoidable adverse breast cancer outcomes in this underserved group.
Of all racial/ethnic groups in the US, Black women have the highest rate of breast cancer
deaths. Two-thirds of Black breast cancer patients have estrogen receptor (ER) positive
tumors that can be treated with adjuvant hormonal therapy. If taken for the full five years,
this therapy has been shown to reduce mortality by 50%. However, ER positive Black women are
more likely to die from their breast cancer as ER positive White women. Preliminary data
suggest that non-adherence to adjuvant hormonal therapy could explain some of this disparity.
To date, no study has systematically examined psychosocial, healthcare, and biological
factors that predict adherence to hormonal therapy in Black women with breast cancer. To
begin to fill this knowledge gap, Investigators will conduct a prospective cohort study of
422 ER positive Black breast cancer patients recruited from health maintenance organizations
(HMOs). Our primary outcome is adherence to therapy at 36 months post initiation. Specific
aims are to: 1) Examine psychosocial factors (e.g. health beliefs, socio-cultural values,
etc.) that predict adherence to hormonal therapy; 2) Identify clinical (e.g., side effects),
and biological (e.g., stage, etc.) factors that predict adherence to hormonal therapy; and 3)
Evaluate healthcare variables (e.g., communication, management of side effects, etc.) that
predict adherence. Investigators will also explore the role of CYP2D6 genetic variations in
adherence to hormonal therapy which is novel and will increase knowledge about this genetic
factor in Blacks. The study is focused on the time-period (first 3 years) when women appear
to be the most vulnerable to terminating treatment prematurely. A better understanding of
predictors of adherence in Black women may help target interventions and ultimately improve
potentially avoidable adverse breast cancer outcomes in this underserved group.
Investigators will employ the Adherence Model of Behavior to identify clinical, psychosocial,
and healthcare delivery predictors of longitudinal hormonal therapy adherence in women with
(hormone receptor) HR positive breast cancer. This study is significant because: (1) most
breast cancers in Blacks and Whites are HR positive (~75%)1,27; (2) hormonal therapy is
recommend for all women with HR positive cancer since it reduces recurrence and mortality;
(3) women who adhere to hormonal therapy have lower mortality than those who do not28; (4)
adherence to hormonal therapy is suboptimal, even in HMO settings; (5) current guidelines
recommend at least 5 years of hormonal therapy6; (6) along with Whites, investigators will
examine adherence behaviors in Blacks, a group reported to have poorer outcomes than Whites,
even among HR positive cases of similar stage;) past studies have documented poor adherence
but few have systematically examined reasons for non-adherence. Overall, our results will be
clinically useful and will inform interventions and pharmacogenetics research. For instance,
if investigators find that communication strongly influences adherence, investigators can
develop and implement patient self-efficacy or physician reminder-based interventions to
enhance communication about adherence between patients and clinicians in HMOs. If
investigators find that different factors predict adherence in Blacks versus Whites,
investigators can develop tailored interventions. The PI has extensive experience developing
tailored interventions to improve communication and uptake of chemotherapy in Blacks and
Latinas.The next sections highlight the background that supports the significance of our
research.
and healthcare delivery predictors of longitudinal hormonal therapy adherence in women with
(hormone receptor) HR positive breast cancer. This study is significant because: (1) most
breast cancers in Blacks and Whites are HR positive (~75%)1,27; (2) hormonal therapy is
recommend for all women with HR positive cancer since it reduces recurrence and mortality;
(3) women who adhere to hormonal therapy have lower mortality than those who do not28; (4)
adherence to hormonal therapy is suboptimal, even in HMO settings; (5) current guidelines
recommend at least 5 years of hormonal therapy6; (6) along with Whites, investigators will
examine adherence behaviors in Blacks, a group reported to have poorer outcomes than Whites,
even among HR positive cases of similar stage;) past studies have documented poor adherence
but few have systematically examined reasons for non-adherence. Overall, our results will be
clinically useful and will inform interventions and pharmacogenetics research. For instance,
if investigators find that communication strongly influences adherence, investigators can
develop and implement patient self-efficacy or physician reminder-based interventions to
enhance communication about adherence between patients and clinicians in HMOs. If
investigators find that different factors predict adherence in Blacks versus Whites,
investigators can develop tailored interventions. The PI has extensive experience developing
tailored interventions to improve communication and uptake of chemotherapy in Blacks and
Latinas.The next sections highlight the background that supports the significance of our
research.
Inclusion Criteria:
- Non-recurrent invasive breast cancer (AJCC Stages I-IV)
- Any race
- English or Spanish speaking and/or reading
- Initiated hormonal therapy within 12 months of definitive diagnosis
Exclusion Criteria:
- HR Negative
- Under the age of 21
- Non-English or Spanish Speaking
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