Breast CancerNCT03447886
Understanding Barriers to Initiation and Adherence to Endocrine Therapy in Young Breast Cancer Survivors of Diverse Backgrounds
An observational study of Breast Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
The overall goal of this study is to qualitatively explore how behavioral, cultural, psychosocial, and economic barriers and facilitators affect the decision to start and adhere to endocrine therapy (ET) among young breast cancer survivors of diverse racial, ethnic, and socio-economic backgrounds with hormone receptor… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Phone interview
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2018to 27 Aug 2018
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women of all races
Who may be able to join
- Are Hispanic, Latina, Black, or identify as socio-economically disadvantaged (any racial/ethnic background) as measured by an item of financial distress answering that they are "having difficulty paying the bills no matter what they do" to a question about their current household financial situation.18, 19
- report a history of Stage 1-3 breast cancer
- reports HR+ breast cancer and confirm that they have had a discussion with their doctor about adjuvant ET; OR indicate that they are taking ET, even if they do not know their HR status, answer they are HR-, or do not recall having a discussion about ET)
- not in active treatment (e.g., chemotherapy, radiation), with the exception of Herceptin
- at least 3 months, but no more than 3 years out of completion of active treatment
- no evidence of recurrent/metastatic disease
Show all 9Show fewer
- at least 18, but< 45 years of age at diagnosis of first invasive breast cancer
- English or Spanish speaking
- are willing to consent to the interview
Who cannot join
- HR- breast cancer and indicate they are not taking ET
- HR+ breast cancer but do not confirm discussion of ET or indicate they are taking ET
- Stage 0 (DCIS) breast cancer
- Recurrent or metastatic disease
- Less than 3 months or more than 3 years post-active treatment
- Less than 18 years old or ≥45 years old at diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Understanding Barriers to Initiation and Adherence to Adjuvant Endocrine Therapy in Young Breast Cancer Survivors of Diverse Racial, Ethnic, and Socio-economic Backgrounds: The EMPOWER Study
The overall goal of this study is to qualitatively explore how behavioral, cultural, psychosocial, and economic barriers and facilitators affect the decision to start and adhere to endocrine therapy (ET) among young breast cancer survivors of diverse racial, ethnic, and socio-economic backgrounds with hormone receptor positive (HR+) breast cancer
Read the detailed description
A qualitative study that will use interviews to gain an in depth understanding of factors affecting the decision to start and adhere to endocrine therapy (ET) among young breast cancer survivors of diverse racial, ethnic, and socio-economic backgrounds with hormone receptor positive (HR+) breast cancer
- Conditions
- Breast Cancer
- Being tested
- Phone interview
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone interviewOther
Collecting clinical and socio-demographic information.
| Study group | Role | What they receive |
|---|---|---|
| Quality Of Life | This study uses qualitative research methods, specifically semi-structured interviews.
* This will include moderator guide development,
* Phone interviews with breast cancer survivors will be conducted
* Qualitative data analysis of the phone interviews will be conducted Receives: Other: Phone interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision-making around endocrine therapy in young women with HR+ breast cancer.
Open ended questions
Measured: 3 months-3 years post active treatment
Secondary outcomes (6)
Barriers and challenges to endocrine therapy adherence
Open ended questions
Measured: 3 months-3 years post active treatment
Social support
Open ended questions
Measured: 3 months-3 years post active treatment
Health behaviors
Open ended questions
Measured: 3 months-3 years post active treatment
Endocrine therapy adherence intervention preferences
Open ended questions
Measured: 3 months-3 years post active treatment
Health literacy
Brief Health Literacy Screener (Chew items)
Measured: 3 months-3 years post active treatment
Menopausal symptoms
BCPT Symptom Checklist
Measured: 3 months-3 years post active treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start9 Mar 2018
- Primary completion27 Aug 2018
- Study completion27 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Other
- Time perspective
- Other
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Rachel Freedman, MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Rachel A Freedman, MD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447886
- Sponsor's protocol ID
- 17-581
- Other IDs
- U54CA156732
- Status last verified
- Jun 2021
- First submitted
- 21 Feb 2018
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Barriers to Initiation and Adherence to Adjuvant Endocrine Therapy in Young Breast Cancer Survivors of Diverse Racial, Ethnic, and Socio-economic Backgrounds: The EMPOWER Study
- ClinicalTrials.gov ID
- NCT03447886
- Acronym / sponsor ID
- 17-581
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 27 Aug 2018 (actual)
- Study completion
- 27 Aug 2018 (actual)
- First posted
- 27 Feb 2018 (actual)
- 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.
The overall goal of this study is to qualitatively explore how behavioral, cultural, psychosocial, and economic barriers and facilitators affect the decision to start and adhere to endocrine therapy (ET) among young breast cancer survivors of diverse racial, ethnic, and socio-economic backgrounds with hormone receptor positive (HR+) breast cancer
Detailed description
A qualitative study that will use interviews to gain an in depth understanding of factors affecting the decision to start and adhere to endocrine therapy (ET) among young breast cancer survivors of diverse racial, ethnic, and socio-economic backgrounds with hormone receptor positive (HR+) breast cancer
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quality Of Life | – | Other: Phone interviewThis study uses qualitative research methods, specifically semi-structured interviews. * This will include moderator guide development, * Phone interviews with breast cancer survivors will be conducted * Qualitative data analysis of the phone interviews will be conducted |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women of all races
Key inclusion criteria (9 listed)
- Are Hispanic, Latina, Black, or identify as socio-economically disadvantaged (any racial/ethnic background) as measured by an item of financial distress answering that they are "having difficulty paying the bills no matter what they do" to a question about their current household financial situation.18, 19
- report a history of Stage 1-3 breast cancer
- reports HR+ breast cancer and confirm that they have had a discussion with their doctor about adjuvant ET; OR indicate that they are taking ET, even if they do not know their HR status, answer they are HR-, or do not recall having a discussion about ET)
- not in active treatment (e.g., chemotherapy, radiation), with the exception of Herceptin
- at least 3 months, but no more than 3 years out of completion of active treatment
Key exclusion criteria (6 listed)
- HR- breast cancer and indicate they are not taking ET
- HR+ breast cancer but do not confirm discussion of ET or indicate they are taking ET
- Stage 0 (DCIS) breast cancer
- Recurrent or metastatic disease
- Less than 3 months or more than 3 years post-active treatment
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 |
|---|---|---|
| Phone interviewCollecting clinical and socio-demographic information. | Other | Quality Of Life |
Primary outcome
Decision-making around endocrine therapy in young women with HR+ breast cancer.
Time frame: 3 months-3 years post active treatment
Open ended questions
6 secondary outcomes
Barriers and challenges to endocrine therapy adherence
Time frame: 3 months-3 years post active treatment
Social support
Time frame: 3 months-3 years post active treatment
Health behaviors
Time frame: 3 months-3 years post active treatment
Endocrine therapy adherence intervention preferences
Time frame: 3 months-3 years post active treatment
Health literacy
Time frame: 3 months-3 years post active treatment
Menopausal symptoms
Time frame: 3 months-3 years post active treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- 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.
Rachel A Freedman, MD, MPH principal investigator
Dana-Farber Cancer Institute
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, run by Dana-Farber Cancer Institute 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 9 inclusion and 6 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: finished, as of the sponsor's last update on 11 Jun 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Decision-making around endocrine therapy in young women with HR+ breast cancer. (time frame: 3 months-3 years post active treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2021.