Improving Surgical/Medical Oncology Collaboration for Breast Cancer Treatment Planning: Pilot Testing the Impact of Continuing Education and Patient Care Planning
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Carevive CPS
Sponsored by

About this trial
This is an interventional screening trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Any patient who cannot understand written or spoken English
Sites / Locations
- Thomas Jefferson University Hospital
Outcomes
Primary Outcome Measures
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.
Rates of actual prescription of neoadjuvant therapy to eligible patients
Data will be collected via chart abstraction
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03161600
Brief Title
Improving Surgical/Medical Oncology Collaboration for Breast Cancer Treatment Planning: Pilot Testing the Impact of Continuing Education and Patient Care Planning
Official Title
Improving Surgical/Medical Oncology Collaboration for Breast Cancer Treatment Planning: Pilot Testing the Impact of Continuing Education and Patient Care Planning
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 18, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carevive Systems, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Carevive CPS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rates of provider self-report and actual percent of eligible patients referred to medical oncology for discussion of neoadjuvant therapy.
Description
Data collected via chart abstraction and provider surveys will be analyzed.
Time Frame
Year 1
Title
Rates of actual prescription of neoadjuvant therapy to eligible patients
Description
Data will be collected via chart abstraction
Time Frame
Year 1
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
Any patient who cannot understand written or spoken English
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Improving Surgical/Medical Oncology Collaboration for Breast Cancer Treatment Planning: Pilot Testing the Impact of Continuing Education and Patient Care Planning
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