Breast CancerNCT03161600
Improving Surgical/Medical Oncology Collaboration for Breast Cancer Treatment Planning: Pilot Testing the Impact of Continuing Education and Patient Care Planning
A study testing Carevive CPS in people with Breast Cancer, run by Carevive Systems, Inc. at 1 site in United States.
Trial summary
This study will explore provider's screening and management practices for eligibility for neoadjuvant therapy from baseline to following the project intervention (use of a novel existing technology, the Carevive Care Planning System at the point of care plus provider continuing medical education. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Carevive CPS
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2017to 31 Dec 2018
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) 18 years of age and older
- 2) Patients must have a diagnosis of breast cancer for which they must not have received or been scheduled for primary breast surgery at time of project intervention, and must be eligible for surgical resection (i.e. Stage I-III).
Who cannot join
- Any patient who cannot understand written or spoken English
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
This study will explore provider's screening and management practices for eligibility for neoadjuvant therapy from baseline to following the project intervention (use of a novel existing technology, the Carevive Care Planning System at the point of care plus provider continuing medical education.
Read the detailed description
The overarching goals are to improve clinician knowledge about evidence-based practices for neoadjuvant therapy for breast cancer, increase appropriate referrals to medical oncology for consideration of preoperative systemic therapy (as determined by adherence to NCCN pre-operative systemic therapy guidelines), and to improve communication between the multidisciplinary team and patient regarding the appropriateness, selection, and timing of neoadjuvant therapy. Secondary objectives include a) evaluation of the impact of the intervention on actual prescription of neoadjuvant therapy to eligible patients and b) evaluation of the impact of the intervention on surgeons and medical oncologists' knowledge, attitudes, and beliefs about the benefits of neoadjuvant therapy. We will also explore the acceptability and utilization of the Carevive care plan during medical oncologists' initial consultations after referral of patients from surgical practices. In this project, 25 newly diagnosed breast cancer patients will be recruited over a 3-6 month period, screened for eligibility for neoadjuvant therapy, and assessed for patient treatment preferences at time of surgical consultation using a novel and commercially available electronic technology, the Carevive Care Planning System (CPS). Patients will receive a care plan that explains neoadjuvant therapy among possible treatment options. In addition, patients will be screened for distress as well as eligibility for genetic counseling (according to NCCN referral criteria) and fertility preservation (according to ASCO guidelines) referrals, and the Carevive care plans provided will also incorporate personalized referrals to these related services where applicable.
Retrospective chart reviews (from both surgical and medical oncology practices participating in this project), complemented by data extracted from the Carevive CPS, will be used to assess changes in rates of referrals to medical oncology for discussion and actual prescriptions of neoadjuvant therapy, as compared to historical data from prior publications documenting low rates of referral to, and receipt of, neoadjuvant therapy. Provider questionnaires exploring knowledge, attitudes, and beliefs about the benefits of neoadjuvant therapy will be completed at baseline and again at follow-up (≤4 weeks following intervention visit of their last patient) and changes will be explored using a pre-/post-test design. Use of a care planning technology to provide tailored education and individualized information may provide an easy, accessible and effective way to improve provider abilities to proactively identify patients eligible for specific therapies, understand patient treatment goals, concerns, drive shared decision making (SDM) and sufficiently collaborate with the multi-disciplinary team to provide optimal care.
- Conditions
- Breast Cancer
- Being tested
- Carevive CPS
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carevive CPSBehavioural
This intervention will focus on the use of the Carevive CPS at a surgical visit, enabling providers to deliver evidence-based and personalized treatment care plans to their breast cancer patients. The Carevive CPS collects electronic patient reported outcomes (ePROS) and clinical data, reported and generated by clinical staff and/or extracted from the electronic medical record (EMR), and uses these to auto-generate the personalized care plans. Care plan content is drive by practice guidelines and other peer-reviewed evidence, and includes patient education, resources, and referrals developed by cancer clinicians and researchers.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of provider self-report and actual percent of eligible patients referred to medical oncology for discussion of neoadjuvant therapy.
Data collected via chart abstraction and provider surveys will be analyzed.
Measured: Year 1
Rates of actual prescription of neoadjuvant therapy to eligible patients
Data will be collected via chart abstraction
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start18 May 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 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.
- 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carevive Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161600
- Sponsor's protocol ID
- G402
- Status last verified
- Jan 2019
- First submitted
- 18 May 2017
- Last updated
- 30 Jan 2019
- 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 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Surgical/Medical Oncology Collaboration for Breast Cancer Treatment Planning: Pilot Testing the Impact of Continuing Education and Patient Care Planning
- ClinicalTrials.gov ID
- NCT03161600
- Acronym / sponsor ID
- G402
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Carevive Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 May 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 22 May 2017 (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.
This study will explore provider's screening and management practices for eligibility for neoadjuvant therapy from baseline to following the project intervention (use of a novel existing technology, the Carevive Care Planning System at the point of care plus provider continuing medical education.
Detailed description
The overarching goals are to improve clinician knowledge about evidence-based practices for neoadjuvant therapy for breast cancer, increase appropriate referrals to medical oncology for consideration of preoperative systemic therapy (as determined by adherence to NCCN pre-operative systemic therapy guidelines), and to improve communication between the multidisciplinary team and patient regarding the appropriateness, selection, and timing of neoadjuvant therapy. Secondary objectives include a) evaluation of the impact of the intervention on actual prescription of neoadjuvant therapy to eligible patients and b) evaluation of the impact of the intervention on surgeons and medical oncologists' knowledge, attitudes, and beliefs about the benefits of neoadjuvant therapy. We will also explore the acceptability and utilization of the Carevive care plan during medical oncologists' initial consultations after referral of patients from surgical practices. In this project, 25 newly diagnosed breast cancer patients will be recruited over a 3-6 month period, screened for eligibility for neoadjuvant therapy, and assessed for patient treatment preferences at time of surgical consultation using a novel and commercially available electronic technology, the Carevive Care Planning System (CPS). Patients will receive a care plan that explains neoadjuvant therapy among possible treatment options. In addition, patients will be screened for distress as well as eligibility for genetic counseling (according to NCCN referral criteria) and fertility preservation (according to ASCO guidelines) referrals, and the Carevive care plans provided will also incorporate personalized referrals to these related services where applicable.
Retrospective chart reviews (from both surgical and medical oncology practices participating in this project), complemented by data extracted from the Carevive CPS, will be used to assess changes in rates of referrals to medical oncology for discussion and actual prescriptions of neoadjuvant therapy, as compared to historical data from prior publications documenting low rates of referral to, and receipt of, neoadjuvant therapy. Provider questionnaires exploring knowledge, attitudes, and beliefs about the benefits of neoadjuvant therapy will be completed at baseline and again at follow-up (≤4 weeks following intervention visit of their last patient) and changes will be explored using a pre-/post-test design. Use of a care planning technology to provide tailored education and individualized information may provide an easy, accessible and effective way to improve provider abilities to proactively identify patients eligible for specific therapies, understand patient treatment goals, concerns, drive shared decision making (SDM) and sufficiently collaborate with the multi-disciplinary team to provide optimal care.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1) 18 years of age and older
- 2) Patients must have a diagnosis of breast cancer for which they must not have received or been scheduled for primary breast surgery at time of project intervention, and must be eligible for surgical resection (i.e. Stage I-III).
Key exclusion criteria (1 listed)
- Any patient who cannot understand written or spoken English
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 |
|---|---|---|
| Carevive CPSThis intervention will focus on the use of the Carevive CPS at a surgical visit, enabling providers to deliver evidence-based and personalized treatment care plans to their breast cancer patients. The Carevive CPS collects electronic patient reported outcomes (ePROS) and clinical data, reported and generated by clinical staff and/or extracted from the electronic medical record (EMR), and uses these to auto-generate the personalized care plans. Care plan content is drive by practice guidelines and other peer-reviewed evidence, and includes patient education, resources, and referrals developed by cancer clinicians and researchers. | Behavioural | – |
Primary outcome
Rates of provider self-report and actual percent of eligible patients referred to medical oncology for discussion of neoadjuvant therapy.
Time frame: Year 1
Data collected via chart abstraction and provider surveys will be analyzed.
Rates of actual prescription of neoadjuvant therapy to eligible patients
Time frame: Year 1
Data will be collected via chart abstraction
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 30 Jan 2019.
- 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?
A study testing Carevive CPS in people with Breast Cancer, run by Carevive Systems, Inc. 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 2 inclusion and 1 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 30 Jan 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?
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?
Rates of provider self-report and actual percent of eligible patients referred to medical oncology for discussion of neoadjuvant therapy. (time frame: Year 1). 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 30 Jan 2019.