Activities & Goals
Goals
The primary goal of the Georgia NCORP Community Site proposal is to increase access and accrual to cancer research to Georgians at risk for and with a diagnosis of cancer in their own communities, with a targeted focus on the underserved. To achieve this goal, three specific aims are proposed based on Denicoff et al (2013):
Aim 1: To increase the percentage of eligible patients at risk for or diagnosed with cancer who have access to and enroll in a cancer clinical trial or care delivery research study within 50 miles of their home.
Aim 2: To increase the number of well-annotated biological specimens linked to de-identified clinical data that are collected and used for cancer research.
Aim 3: To overcome barriers to genetic risk screening, counseling, and testing for high-risk women with a familial history of breast or ovarian cancer.
Progress Towards Goals
By leveraging the infrastructure and communication platform established during the first 2 years, and incorporating member feedback and continued performance review, the Georgia NCI Community Oncology Research Program (GA NCORP) was able to meet and/or exceed expectations outlined in the Specific Aims.
To accomplish the primary aims of the GA NCORP, three teams of interdisciplinary cancer care professionals representing research network members were established: Clinical Research Team, Biospecimen Team, and CCDR Team. The major accomplishments of these teams in building collaborative relationships, identifying outcomes to measure achievement of aims, obtaining baseline data of outcome measures and standardizing reporting mechanisms are presented in the following section. Each team reports quarterly to the Executive and Scientific Review Committees.
Overall accrual performance for year 3 has been better than expected. GA NCORP is currently at 104% of expected accrual credits and plans to meet and/or exceed our accrual credit goals, maintaining the top quartile ranking across NCORPs nationally. Efforts to balance the trial portfolio have also been successful, increasing Cancer Control & Prevention (CCP) trials from 5 to 11 and opening two (2) CCDR studies.GA NCORP continues to be ranked in the top 5 accruing NCORPs to Precision Medicine trials, exceeding our accrual goal for year 3 by 150%. Ancillary biospecimen submission has increased by 75%. Efforts to engage minority and underrepresented populations remains a priority. Racial & ethnic minority accruals increased from 18% to 22%, while elderly (>65) & rural accruals held steady at 41% and 20%, respectively. All eligible members have opened DCP-001, 21 patients accrued, 3 did not enroll in the CCP study (2 did not meet eligibility, 1 declined).
Network member engagement is key to the success of the GA NCORP. Enhanced efforts to provide real-time feedback using various communication tools (ie. face to face meetings, webex team meetings, GA NCORP website, periodic newsletter, etc) to the network members regarding accomplishments, opportunities, challenges, and trial & accrual activity has shown to be effective. Physician engagement continues to rise, increasing from 37% in Year 1 to 46% in Year 3. Contributions to affiliated Research Bases (RB) remains strong, with GA NCORP Investigators, research nurses, and CRAs providing representation on various NCI and RB committees and task forces, co-authoring publications, and contributing to protocol development .
|
Table 1. Summary of GA NCORP Accruals 08.01.16 through 04.30.17
|
|
Accruals
|
Treatment
CCP
Precision Medicine CCDR
DCP-001
|
82
29
94
2
21
|
|
Accruals Research Base
|
NRG
ECOG-ACRIN
SWOG
Wake Forest
|
39
120
22
1
|
|
Ancillary Studies
|
Advanced Imaging
Quality of Life
Biospecimen
|
4
29
325
|
|
Top 3 Disease Types
|
Lung
Breast
Colorectal/GYN
|
53
33
28
|
|
Gender
|
Females
Males
|
133
72
|
|
Age Range*
|
Young (15-39 years)
Middle (40-64 years)
Elder (65 years +)
|
15
106
84
|
|
Race
|
Caucasian
African-American
Asian
Unknown
|
159
41
3
2
|
|
Ethnicity
|
Non-Hispanic
Hispanic
Not Reported
|
202
1
2
|
|
Rural
|
Rural
Non-Rural
|
42
163
|
The Research Network Team continues to improve operations with communication and sharing best practices between the Research Network Members, acccomplishments are listed below:
- Developed learning needs assessment by CT AIM categories
- Revised and updated Research Network Standard Operating Procedures (SOPs)
- Created Quality Issues Tracking Report, a process for reporting and follow up on outstanding issues
- Provided quarterly reports on clinical trials portfolio, accrual activity, physician engagement, patient demographics and quality issues to Executive and Scientific Review Committees
- Prepared annual summary reports customized for each Research Network Member
To accomplish the primary aims of the GA NCORP, the three teams of interdisciplinary cancer care professionals representing research network members continued to meet regularly: Clinical Research Team, Biospecimen Team, and CCDR Team. The major accomplishments of these are presented in the following section. Each team reports quarterly to the Executive and Scientific Review Committees.
Clinical Research Team Accomplishments
- Exceeded overall accrual goal, currently at 205 accruals (103% of annual goal)
- Added new members to the CR team and detailed the expectations for participation
- Revised schedule with bi-monthly calls and two (2) face-to-face meetings annually
- Held face-to-face meeting with Lead Investigators from each Research Network Member in attendance; identified strategies and best practices to aid accrual including
- Recognized top accruing Investigators with e mail from Chair, inclusion of top accruers in performance report and updates to Executive and Scientific Review Committees
- Introduced, distributed and reviewed Open Clinical Trials Report and Portfolio Summary Report
- Provided Investigator representation on NCI Ovarian, BOLD & Uterine Task Forces
- Provided Nursing / CRA representation on ECOG Cancer Control and Outcomes, Pharmacy, MATCH, & Melanoma Committees; SWOG Quality of Life/Patient Reported Outcomes (PRO), Symptom Control, Lung MAP & ORP Executive Committees; NRG Clinical Trials Nurses, Mentorship, GYN, Education & Training, & Protocol Review Committees
Biospecimen Team Accomplishments
- Held monthly conference calls with representation from the GA NCORP Research Network Members
- Increased the number of high-quality biospecimens submitted to NCI Clinical Trials by 75% (from 187 to 325) for the 1st nine months of year 2 & 3
- Evaluated and provided biospecimen-related recommendations to the Scientific Review Committee for selection of Georgia NCORP network trials that call for collection of biospecimens
- Initiated development of processes and metrics to assist operations of, and to assess outcomes for, the Georgia NCORP Biospecimen initiative
- Continued bi-monthly educational “Hot Topics” segment to share best practices
Cancer Care Delivery Research Team Accomplishments
- Conducted quarterly CCDR Team Meetings with GA NCORPmembers to include updates of upcoming studies obtained from RB meeting attendance
- Developed infrastructure and engaged hospital administration to rapidly evaluate and determine feasibility for opening NCI CCDR trials
- Evaluated CCDR study participation barriers
- Participated in CCDR Landscape Survey and all CCDR surveys and data request from the NCI and RBs
- Opened CCDR SWOG studies S1415CD and S1417CD
- Provided GA NCORP PRO-GENESCREEN CCDR Genomics Research Concept to SWOG, NRG and Wake Forest for review and presented at RB meetings
- Provided PI, administrative and nursing representation on NCI and RB CCDR Committees to include ECOG, NRG and Wake Forest
- Attended all NCORP Administrative & CCDR webinars and NCI & RB CCDR meetings
- Made significant progress in referrals of ovarian cancer patients to genetic counseling, exceeding the national average
- Utilized GA NCORP website to share CCDR educational materials and NCI information to members