CancerSUPPORTNCT02232074
Socio-legal Services for Underserved Populations Through Patient Navigation to Optimize Resources During Treatment
A study testing Patient navigation enhanced with legal support in people with Cancer, run by Boston Medical Center at 1 site in United States.
Trial summary
The investigators plan to compare standard patient navigation with an enhanced navigation partnered with the Medical Legal Partnership | Boston (MLP) to determine if assessing legal needs of newly diagnosed cancer patients in addition to other barriers to care leads to better clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Patient navigation enhanced with legal support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 1 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed breast and lung cancer patients
- Within 30 days of patient being informed of diagnosis
- Receiving cancer care at Boston Medical Center
- No history of cancer treatment in past 5 years
- No cognitive impairments
- Over 18 years of age
- Speak English, Spanish or Haitian Creole
Who cannot join
- Patient informed of cancer diagnosis >30 days
- Patient under 18 yrs. of age
- Primary language something other than English, Spanish or Haitian Creole
- Undergoing treatment for concurrent cancer
- Patient has history of cancer or has received cancer treatment within the last 5 years
- Institutionalized/cognitive impairment (such as: dementia or metabolic, medication or drug induced), given the unique challenges to their treatment decision making/adherence and the fact that the intervention would not include the patient directly, but rather the family.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Project SUPPORT (Socio-legal Services for Underserved Populations Through Patient Navigation to Optimize Resources During Treatment)
The investigators plan to compare standard patient navigation with an enhanced navigation partnered with the Medical Legal Partnership | Boston (MLP) to determine if assessing legal needs of newly diagnosed cancer patients in addition to other barriers to care leads to better clinical outcomes.
Read the detailed description
Differences and delays in the delivery of cancer care lead to more advanced cancer at the time of diagnosis and ultimately to more deaths for low-income and minority communities. Our group helped develop a patient-navigation model using lay health workers to address patient barriers and coordinated cancer-care services, leading to more timely care. Despite the fact that patient navigation is now a standard required by the Commission on Cancer, the investigators' research shows that delays in care persist for our low-income patients with socio-legal barriers. Socio-legal barriers are defined as social problems related to meeting life's most basic needs that are supported by public policy or programming and thus potentially remedied through legal advocacy/action (e.g., unsafe/unstable housing, unlawful utility shutoffs, or job termination). Direct feedback from cancer patients suggests a critical need to address socio-legal barriers in order to achieve quality care for all. To expand the current impact of patient navigation on quality care for low-income patients, the investigators will partner with patients, key community stakeholders, and the Medical-Legal Partnership (MLP)|Boston, the founding site of a nationwide program assisting healthcare teams in addressing socio-legal barriers to health. Under direction from a Patient Advisory Group and a Community Advisory Board, the investigators will conduct a study to compare standard navigation with an MLP navigation intervention enhanced by legal support for low-income cancer patients.
The investigators will enroll 374 low-income, racially diverse, newly diagnosed cancer patients. Half will receive standard navigation, i.e., a lay navigator integrated into the healthcare team who provides one-on-one patient contact to address traditional system barriers to care. The other half will receive MLP navigation, i.e., standard navigation enhanced by legal support including:
- a full socio-legal needs assessment and care plan in consultation with MLP; and
- legal assistance for eligible urgent legal needs. We will compare each group on all outcomes.
Compared to standard navigation, we expect that addressing socio-legal barriers to care with MLP navigation will improve patient-reported outcomes and lead to more timely care delivery. Because of widespread national availability of patient navigation and MLP programs at hospitals serving vulnerable patients, this intervention can be quickly replicated to improve patient experience and survival.
- Conditions
- Cancer
- Being tested
- Patient navigation enhanced with legal support
- Keywords
- Patient Navigation, Medical Legal Partnership, Healthcare Disparities
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient navigation enhanced with legal supportOther
| Study group | Role | What they receive |
|---|---|---|
| Patient navigation enhanced with legal support | Experimental | In addition to receiving standard navigation, patients will be connected with a Patient Navigator who is partnered with a lawyer from Medical-Legal Partnership to provide personalized assistance with regard to social-legal barriers. Receives: Other: Patient navigation enhanced with legal support |
| Standard patient navigation | No intervention | These patients will receive standard patient navigation which will work to ensure that services are coordinated amongst medical personnel, while also addressing patients' needs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among BREAST Cancer Participants
The receipt of timely care will be defined as initiation of care within 90 days, as this the shortest delay that has been shown to consistently affect mortality The time element was calculated from date of diagnosis (Time0) to date of treatment initiation (Time1) .The date chosen for the Time1 variable depends on the recommended care plan for each patient, as derived from the chart abstraction and based on patient presentation.
Measured: Receipt of 1st treatment within 90 days from diagnosis
Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among LUNG Cancer Participants
The receipt of timely care will be defined as initiation of care within 90 days, as this the shortest delay that has been shown to consistently affect mortality The time element was calculated from date of diagnosis (Time0) to date of treatment initiation (Time1) .The date chosen for the Time1 variable depends on the recommended care plan for each patient, as derived from the chart abstraction and based on patient presentation.
Measured: Receipt of 1st treatment within 90 days from diagnosis
Secondary outcomes (19)
Distress Thermometer at 3 Months for BREAST Cancer Patients
Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower values are more favorable.
Measured: 3 months after enrollment
Distress Thermometer at 3 Months for LUNG Cancer Patients
Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower values are more favorable.
Measured: 3 months after enrollment
Distress Thermometer at 6 Months for BREAST Cancer Patients
Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower values are more favorable.
Measured: 6 months after enrollment
Distress Thermometer at 6 Months for LUNG Cancer Patients
Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress).Lower values are more favorable.
Measured: 6 months after enrollment
Cancer Needs and Distress Inventory at 6 Months for BREAST Cancer Patients
Patient needs were assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 38-item self-report instrument that rates need and distress level in the past two weeks using a 5 -point Likert scale where 1=not a problem to 5=very severe problem. For this analysis, the mean total score is reported with the minimum value=1 and the maximum value=4.10. Lower values are more favorable.
Measured: 6 months post-enrollment
Cancer Needs and Distress Inventory at 6 Months for LUNG Cancer Patients
Patient needs were assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 38-item self-report instrument that rates need and distress level in the past two weeks using a 5 -point Likert scale where 1=not a problem to 5=very severe problem. For this analysis, the mean total score is reported with the minimum value=1 and the maximum value=2.3. Lower values are more favorable.
Measured: 6 months post-enrollment
Patient Satisfaction With Navigation at 6 Months Among BREAST Cancer Patients
Patient's satisfaction assessed through the Patient Satisfaction with Interpersonal Relationship with Navigator Measure (PSN-1) questionnaire. Each question of the 9-item instrument has a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Responses are summed for a total score. The higher the score, the higher patient's satisfaction with navigation. The minimum value=9 and the maximum value=45. Higher values are more favorable.
Measured: 6 months post-enrollment
Patient Satisfaction With Navigation at 6 Months Among LUNG Cancer Patients
Patient's satisfaction assessed through the Patient Satisfaction with Interpersonal Relationship with Navigator Measure (PSN-1) questionnaire. Each question of the 9-item instrument has a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Responses are summed for a total score. The higher the score, the higher patient's satisfaction with navigation. The minimum value=9 and the maximum value=45. Higher values are more favorable.
Measured: 6 months post-enrollment
Self-efficacy for BREAST Cancer Patients at 6 Months
Self-Efficacy will be assessed through patient interviews utilizing the Communication and Attitudinal Self-Efficacy (CASE). The CASE is a 12-item instrument that rates self-efficacy in three domains: (1) seeking and obtaining information, (2) understanding and participating in care, and (3) maintaining a positive attitude. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.
Measured: 6 months post-enrollment
Self-efficacy for LUNG Cancer Patients at 6 Months
Self-Efficacy will be assessed through patient interviews utilizing the Communication and Attitudinal Self-Efficacy (CASE). The CASE is a 12-item instrument that rates self-efficacy in three domains: (1) seeking and obtaining information, (2) understanding and participating in care, and (3) maintaining a positive attitude. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.
Measured: 6 months post-enrollment
Number of Participants Receiving Radiation Within 365 Days of Cancer Diagnosis
The receipt of quality care is defined as receiving radiation to the breast within one year of a breast cancer diagnosis if: under the age of 70, estrogen or progesterone tumor positive and had breast conserving surgery.
Measured: Measured at 12 months
Distress Thermometer at 12 Months for BREAST Cancer Patients
Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower values are more favorable
Measured: 12 months after enrollment
Distress Thermometer at 12 Months for LUNG Cancer Patients
Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower scores are more favorable.
Measured: 12 months after enrollment
Cancer Needs and Distress Inventory at 12 Months for BREAST Cancer Patients
Patient needs were assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 38-item self-report instrument that rates need and distress level in the past two weeks using a 5 -point Likert scale where 1=not a problem to 5=very severe problem. The mean total score is reported.
Measured: 12 months post-enrollment
Cancer Needs and Distress Inventory at 12 Months for LUNG Cancer Patients
Patient needs were assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 38-item self-report instrument that rates need and distress level in the past two weeks using a 5 -point Likert scale where 1=not a problem to 5=very severe problem. The mean total score is reported.
Measured: 12 months post-enrollment
Patient Satisfaction With Navigation at 12 Months Among BREAST Cancer Patients
Patient's satisfaction assessed through the Patient Satisfaction with Interpersonal Relationship with Navigator Measure (PSN-1) questionnaire. Each question of the 9-item instrument has a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Responses are summed for a total score. The higher the score, the higher patient's satisfaction with navigation. The minimum value=9 and the maximum value=45. Higher scores are more favorable.
Measured: 12 months post-enrollment
Patient Satisfaction With Navigation at 12 Months Among LUNG Cancer Patients
Patient's satisfaction assessed through the Patient Satisfaction with Interpersonal Relationship with Navigator Measure (PSN-1) questionnaire. Each question of the 9-item instrument has a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Responses are summed for a total score. The higher the score, the higher patient's satisfaction with navigation. The minimum value=9 and the maximum value=45. Higher scores are more favorable.
Measured: 12 months post-enrollment
Self-efficacy for BREAST Cancer Patients at 12 Months
Self-Efficacy will be assessed through patient interviews utilizing the Communication and Attitudinal Self-Efficacy (CASE). The CASE is a 12-item instrument that rates self-efficacy in three domains: (1) seeking and obtaining information, (2) understanding and participating in care, and (3) maintaining a positive attitude. A higher score indicates a positive attitude and strong self-efficacy. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.
Measured: 12 months post-enrollment
Self-efficacy for LUNG Cancer Patients at 12 Months
Self-Efficacy will be assessed through patient interviews utilizing the Communication and Attitudinal Self-Efficacy (CASE). The CASE is a 12-item instrument that rates self-efficacy in three domains: (1) seeking and obtaining information, (2) understanding and participating in care, and (3) maintaining a positive attitude. A higher score indicates a positive attitude and strong self-efficacy. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.
Measured: 12 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study startFeb 2014
- Primary completion1 Apr 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc., Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Battaglia, Tracy, Boston Medical Center
- Investigators
- Tracy A Battaglia, M.D., M.P.H, Principal investigator, Boston Medical CenterSharon Bak, M.P.H, Study director, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232074
- Sponsor's protocol ID
- H-32599
- Other IDs
- RSG-13-368-01-CPPB, AD-1304-6272
- Acronym
- SUPPORT
- Status last verified
- Oct 2019
- First submitted
- 2 Sep 2014
- Last updated
- 15 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- 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 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project SUPPORT (Socio-legal Services for Underserved Populations Through Patient Navigation to Optimize Resources During Treatment)
- ClinicalTrials.gov ID
- NCT02232074
- Acronym / sponsor ID
- SUPPORT / H-32599
- Conditions
- Cancer
- Keywords
- Patient Navigation, Medical Legal Partnership, Healthcare Disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc., Patient-Centered Outcomes Research Institute
- Study start
- Feb 2014 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 4 Sep 2014 (estimated)
- Results
- Posted 11 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators plan to compare standard patient navigation with an enhanced navigation partnered with the Medical Legal Partnership | Boston (MLP) to determine if assessing legal needs of newly diagnosed cancer patients in addition to other barriers to care leads to better clinical outcomes.
Detailed description
Differences and delays in the delivery of cancer care lead to more advanced cancer at the time of diagnosis and ultimately to more deaths for low-income and minority communities. Our group helped develop a patient-navigation model using lay health workers to address patient barriers and coordinated cancer-care services, leading to more timely care. Despite the fact that patient navigation is now a standard required by the Commission on Cancer, the investigators' research shows that delays in care persist for our low-income patients with socio-legal barriers. Socio-legal barriers are defined as social problems related to meeting life's most basic needs that are supported by public policy or programming and thus potentially remedied through legal advocacy/action (e.g., unsafe/unstable housing, unlawful utility shutoffs, or job termination). Direct feedback from cancer patients suggests a critical need to address socio-legal barriers in order to achieve quality care for all. To expand the current impact of patient navigation on quality care for low-income patients, the investigators will partner with patients, key community stakeholders, and the Medical-Legal Partnership (MLP)|Boston, the founding site of a nationwide program assisting healthcare teams in addressing socio-legal barriers to health. Under direction from a Patient Advisory Group and a Community Advisory Board, the investigators will conduct a study to compare standard navigation with an MLP navigation intervention enhanced by legal support for low-income cancer patients.
The investigators will enroll 374 low-income, racially diverse, newly diagnosed cancer patients. Half will receive standard navigation, i.e., a lay navigator integrated into the healthcare team who provides one-on-one patient contact to address traditional system barriers to care. The other half will receive MLP navigation, i.e., standard navigation enhanced by legal support including:
- a full socio-legal needs assessment and care plan in consultation with MLP; and
- legal assistance for eligible urgent legal needs. We will compare each group on all outcomes.
Compared to standard navigation, we expect that addressing socio-legal barriers to care with MLP navigation will improve patient-reported outcomes and lead to more timely care delivery. Because of widespread national availability of patient navigation and MLP programs at hospitals serving vulnerable patients, this intervention can be quickly replicated to improve patient experience and survival.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient navigation enhanced with legal support | Experimental | Other: Patient navigation enhanced with legal supportIn addition to receiving standard navigation, patients will be connected with a Patient Navigator who is partnered with a lawyer from Medical-Legal Partnership to provide personalized assistance with regard to social-legal barriers. |
| Standard patient navigation | No intervention | –These patients will receive standard patient navigation which will work to ensure that services are coordinated amongst medical personnel, while also addressing patients' needs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Newly diagnosed breast and lung cancer patients
- Within 30 days of patient being informed of diagnosis
- Receiving cancer care at Boston Medical Center
- No history of cancer treatment in past 5 years
- No cognitive impairments
Key exclusion criteria (6 listed)
- Patient informed of cancer diagnosis >30 days
- Patient under 18 yrs. of age
- Primary language something other than English, Spanish or Haitian Creole
- Undergoing treatment for concurrent cancer
- Patient has history of cancer or has received cancer treatment within the last 5 years
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 |
|---|---|---|
| Patient navigation enhanced with legal support | Other | Patient navigation enhanced with legal support |
Primary outcome
Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among BREAST Cancer Participants
Time frame: Receipt of 1st treatment within 90 days from diagnosis
The receipt of timely care will be defined as initiation of care within 90 days, as this the shortest delay that has been shown to consistently affect mortality The time element was calculated from date of diagnosis (Time0) to date of treatment initiation (Time1) .The date chosen for the Time1 variable depends on the recommended care plan for each patient, as derived from the chart abstraction and based on patient presentation.
Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among LUNG Cancer Participants
Time frame: Receipt of 1st treatment within 90 days from diagnosis
The receipt of timely care will be defined as initiation of care within 90 days, as this the shortest delay that has been shown to consistently affect mortality The time element was calculated from date of diagnosis (Time0) to date of treatment initiation (Time1) .The date chosen for the Time1 variable depends on the recommended care plan for each patient, as derived from the chart abstraction and based on patient presentation.
19 secondary outcomes
Distress Thermometer at 3 Months for BREAST Cancer Patients
Time frame: 3 months after enrollment
Distress Thermometer at 3 Months for LUNG Cancer Patients
Time frame: 3 months after enrollment
Distress Thermometer at 6 Months for BREAST Cancer Patients
Time frame: 6 months after enrollment
Distress Thermometer at 6 Months for LUNG Cancer Patients
Time frame: 6 months after enrollment
Cancer Needs and Distress Inventory at 6 Months for BREAST Cancer Patients
Time frame: 6 months post-enrollment
Cancer Needs and Distress Inventory at 6 Months for LUNG Cancer Patients
Time frame: 6 months post-enrollment
Patient Satisfaction With Navigation at 6 Months Among BREAST Cancer Patients
Time frame: 6 months post-enrollment
Patient Satisfaction With Navigation at 6 Months Among LUNG Cancer Patients
Time frame: 6 months post-enrollment
Self-efficacy for BREAST Cancer Patients at 6 Months
Time frame: 6 months post-enrollment
Self-efficacy for LUNG Cancer Patients at 6 Months
Time frame: 6 months post-enrollment
Number of Participants Receiving Radiation Within 365 Days of Cancer Diagnosis
Time frame: Measured at 12 months
Distress Thermometer at 12 Months for BREAST Cancer Patients
Time frame: 12 months after enrollment
Distress Thermometer at 12 Months for LUNG Cancer Patients
Time frame: 12 months after enrollment
Cancer Needs and Distress Inventory at 12 Months for BREAST Cancer Patients
Time frame: 12 months post-enrollment
Cancer Needs and Distress Inventory at 12 Months for LUNG Cancer Patients
Time frame: 12 months post-enrollment
Patient Satisfaction With Navigation at 12 Months Among BREAST Cancer Patients
Time frame: 12 months post-enrollment
Patient Satisfaction With Navigation at 12 Months Among LUNG Cancer Patients
Time frame: 12 months post-enrollment
Self-efficacy for BREAST Cancer Patients at 12 Months
Time frame: 12 months post-enrollment
Self-efficacy for LUNG Cancer Patients at 12 Months
Time frame: 12 months post-enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Tracy A Battaglia, M.D., M.P.H principal investigator
Boston Medical Center
Sharon Bak, M.P.H study director
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient navigation enhanced with legal support in people with Cancer, run by Boston Medical Center 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 7 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 15 Oct 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?
Yes. Results are posted in the registry (first posted 11 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among BREAST Cancer Participants (time frame: Receipt of 1st treatment within 90 days from diagnosis). The study lists 2 primary outcomes in all. 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 15 Oct 2019.