Breast Cancer FemaleWHIPNCT02992730
Predictors of Adjuvant Endocrine Therapy in Women With Breast Cancer
An observational study of Breast Cancer Female, run by Georgetown University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 630 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants for this study are ER positive women over the age of 21 diagnosed with breast cancer.
Who may be able to join
- 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
Who cannot join
- HR Negative
- Under the age of 21
- Non-English or Spanish Speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University
Washington D.C., District of Columbia, 20007
About this study
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.
Read the detailed description
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.
- Conditions
- Breast Cancer Female
- Being tested
- No Intervention
- Keywords
- Medication Adherence
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionBehavioural
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Women Diagnosed with Breast Cancer | Observational - Usual Care Receives: Behavioral: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to hormonal therapy at 36 months post initiation - Survey
Examine psychosocial factors (e.g. health beliefs, socio-cultural values, etc.) that predict adherence to hormonal therapy.
Evaluate healthcare variables (e.g., communication, management of side effects, etc.) that predict adherence.
Measured: Baseline to end of followup - 3 years.
Secondary outcomes (1)
Clinical Factors - Medical Record Review
Identify clinical (e.g., side effects), and biological (e.g., stage, etc.) factors that predict adherence to hormonal therapy.
Measured: Baseline to the end of follow-up - 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startApr 2011
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Georgetown 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992730
- Sponsor's protocol ID
- Sheppard_WHIP_Study
- Acronym
- WHIP
- Status last verified
- Apr 2019
- First submitted
- 5 Dec 2016
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Edmonds MC, Sutton AL, Cummings Y, Sheppard VB. Opportunities to Improve Women's Health: Engaging Racial/Ethnic Diverse Women to Provide Biospecimens for Research. J Womens Health (Larchmt). 2021 Sep;30(9):1321-1327. doi: 10.1089/jwh.2020.8502. Epub 2021 Jan 11.
PubMed 33428522
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Adjuvant Endocrine Therapy in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT02992730
- Acronym / sponsor ID
- WHIP / Sheppard_WHIP_Study
- Conditions
- Breast Cancer Female
- Keywords
- Medication Adherence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 630 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women Diagnosed with Breast Cancer | – | Behavioral: No InterventionObservational - Usual Care |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants for this study are ER positive women over the age of 21 diagnosed with breast cancer.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- HR Negative
- Under the age of 21
- Non-English or Spanish Speaking
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 |
|---|---|---|
| No InterventionNo Intervention | Behavioural | Women Diagnosed with Breast Cancer |
Primary outcome
Adherence to hormonal therapy at 36 months post initiation - Survey
Time frame: Baseline to end of followup - 3 years.
Examine psychosocial factors (e.g. health beliefs, socio-cultural values, etc.) that predict adherence to hormonal therapy. Evaluate healthcare variables (e.g., communication, management of side effects, etc.) that predict adherence.
1 secondary outcome
Clinical Factors - Medical Record Review
Time frame: Baseline to the end of follow-up - 3 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Derived from this study: PubMed 33428522Edmonds MC, Sutton AL, Cummings Y, Sheppard VB. Opportunities to Improve Women's Health: Engaging Racial/Ethnic Diverse Women to Provide Biospecimens for Research. J Womens Health (Larchmt). 2021 Sep;30(9):1321-1327. doi: 10.1089/jwh.2020.8502. Epub 2021 Jan 11.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female, run by Georgetown University at 1 site 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Adherence to hormonal therapy at 36 months post initiation - Survey (time frame: Baseline to end of followup - 3 years.). 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 NCT02992730, 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 7 Jun 2019.