NCDB Special Study: Post-Active Treatment Surveillance in Prostate Cancer. Project Overview Ronald C. Chen, MD MPH

Transcription

1 NCDB Special Study: Post-Active Treatment Surveillance in Prostate Cancer Project Overview Ronald C. Chen, MD MPH

2 Introductions Principal Investigator: Ronald C. Chen, MD MPH ACS Staff: Eileen Tonner, MS: Project Manager Zahed Ali Mohammed: Software Developer Amanda Francescatti, MS: Manager

3 Goals for Today Why we are doing this Why this study matters Special study overview Web form overview Questions

4 Cancer Surveillance Post-Treatment Around 3 million (and growing) prostate cancer survivors in U.S. Post-cancer treatment surveillance: Detection of local/regional recurrence Detection of distant metastases Monitoring of treatment toxicities Management of patient anxiety and other patient reported outcomes Assure continuation of primary care/other health care

5 Current Gaps in Evidence Surveillance frequencies have remained unchanged for 10 years Recommendations on surveillance frequency range from every 3 months (4x/year) to annually (1x/year), reflecting significant clinical uncertainty Current recommendations are one-size-fits-all and do not distinguish patients based on risk of recurrence or initial type of treatment (surgery or radiation)

6 Cancer Surveillance Post-Treatment Optimal approach to post-treatment surveillance unknown Lack of data = variations Guidelines vary Not tailored to individuals Prospective randomized controlled trial not feasible at this time

7 Study Aim What are the potential benefits (survival) and harms (receipt of tests/procedures, treatments, and resulting morbidity) of different surveillance frequencies in different patient groups?

8 Special Study Projects Objectives Provide patient-centered, risk-stratified tailored approach to surveillance following active treatment for prostate cancer Maximize survival and minimize burden to patients Reduce patient anxiety and improve efficiency of testing More patient-centered and effective than the current untailored approach Results will be used in the development of unique patient-centered decision-support tool

9 Special Study Surveillance Project Compare the effectiveness of different surveillance frequencies in these 6 patient groups: Primary Surgery Low Risk Cancer Primary Surgery Intermediate Risk Primary Surgery High Risk Cancer Primary Radiation Low Risk Cancer Primary Radiation Intermediate Risk Primary Radiation High Risk Cancer

10 Special Study Surveillance Project Primary treatment: first of radical prostatectomy or radiation (brachytherapy and/or external beam RT) Outcomes Recurrence and survival Additional testing, treatments for recurrence, associated morbidity, false positives

11 Special Study Details Collecting critical patient information using special study mechanism Update vital status, comorbidities, and first course treatment fields as needed PSA testing information (common error) Biopsy information Recurrence information

12 Special Study Details Standardized web-based data collection tool Data collection instructions provided to registrars 12 patients from each site that must: Have evidence that medical records are available for 8 years or until distant recurrence or death (whichever is first) Know who these physicians are: Urologist Primary care Radiation oncologist (if patient received radiation) Have at least 1 PSA test result within 2 years after end of primary treatment Staff at the NCDB uploads cases to web form

13 PSA is Key!! Accurate information on PSA tests (after primary treatment) Determines surveillance frequency (for comparison groups) Determines recurrence

14 Recurrence Information Date of recurrence Type of recurrence (e.g., local, abdominal or pelvic nodal, distant) Treatment for recurrence (e.g., radiation, hormone therapy, chemotherapy) Start and end dates of treatment Location of surgery/radiation

15 Special Study Opportunities Assess error rate of PSA, Gleason scores and dates in the NCDB Studies will help determine optimal follow-up strategy for patients

16 Special Study Details Eileen Tonner, MS

17 Participation Participation in this special study is required by all CoC accredited sites to fulfill Standard 5.7 (with the exception of Veterans Affairs, Department of Defense, and pediatric facilities) Sites with a reference date after 1/1/08 are invited to participate if they have patients from 2008 only. For Integrated Network Cancer Programs, data will need to be submitted for each facility in the network Merged facilities will participate in the study Pilot study completed in January 2017: 7 sites Data collection will begin on April 17 th, 2017 The deadline to submit all patient data is July 17 th, 2017

18 Data Submission Link to web form will be posted to Datalinks 4/17/17 Only registrars and co-registrars will have access Data collection must be completed by a Certified Tumor Registrar This follows the requirements set forth by Standard 5.1, Cancer Registrar Credentials Case abstracting is performed by a CTR Noncredentialed staff who are abstracting and who are in the three-year grace period are supervised by a CTR

19 Inclusion Criteria Evidence that medical records are available for the patient for 8 years or until distant recurrence or death For patients who received primary radical prostatectomy: the patient s urologist and primary care physician can be identified For patients who received primary radiotherapy: the patient s radiation oncologist and urologist and primary care physician can be identified The patients has at least 1 PSA test result within 2 years after end of primary treatment and registrar is confident in capturing PSA information for 2 years after primary treatment completion

20 Surveillance Period First treatment (only 2 possible treatments): either radical prostatectomy or radiation treatment, whichever is the first treatment administered after diagnosis Radiation treatment includes external beam radiation and/or brachytherapy. Note: androgen deprivation therapy (ADT) is not considered first treatment. Surveillance start date: For patients undergoing surgery as first course treatment, this date will be the date of the radical prostatectomy surgery. For patients undergoing radiation treatment as first course treatment, this will be the last date of external beam radiation or brachytherapy (if patient had both types of radiation, choose the later date). The surveillance period is the 8 years following the surveillance start date OR until the date the selected patient experiences a distant recurrence, as defined in this data dictionary, OR the date of death, whichever is first.

21 Follow-up Letter Request records from physicians providing follow up care for a patient s cancer Follow-up letter can be sent to physicians providing follow up care for a patient s cancer Document listing Special Study Data Items can be sent with the letter Suggest registrars use for 2-3 weeks to determine eligibility for 12 patients

22 Obtaining Follow-Up Information The following strategies were used by registrars during the prostate pilot study to help find complete follow-up information for selected patients 1. Call and talk to either a medical records person or the nurse 2. Go through all available records and make a spreadsheet identifying the patients and all physicians they had seen pertaining to the study 3. Use follow up staff to help obtain this information and reach out to other registries for help 4. Look at the urologist and/or radiation oncologist notes. They would specify if the patient was disease free and normally document what the previous PSA was and the date. Then, use that date to search for the PSA result

23 Web Form Review Determination of Eligibility Tab NCDB Clinical Information Tab Comorbidities Tab Additional Clinical Information Tab Surveillance Tab PSA Tab Testosterone Tab Scan Tab Biopsy Tab Recurrence Tab New Cancer Diagnosis Tab

24 Web Form Link On the Datalinks homepage, registrars and co-registrars will see the heading Commission on Cancer Special Study. Underneath this heading, there is a link entitled NCDB: Post-treatment surveillance in prostate cancer- PCORI

25 User Log-in

26 Facility Log-in

27 Patient Selection

28 Web Form Overview

29 Eligibility Yes needs to be answered to all three eligibility questions in order for a patient to be eligible Patient must be eligible before moving on to other tabs If No is answered for one or more questions, click submit and a patient will automatically be replaced If a patient is initially marked eligible and later found to be ineligible, use the Contact Us feature and explain why a replacement case is needed The study staff will then replace the patient for you

30 Collapsing Section Headers

31 Add New PSA Test

32 Surveillance Questions

33 FAQ/Contact

34 Web Form Notes Save vs. submit buttons Save periodically to avoid losing data We recommend waiting until the end to submit cases, in case additional outside records come in If a case is submitted and changes need to be made to it, contact specialstudy@facs.org Cases will only be submitted electronically via the web form

35 s All communication s for the Special Study are being sent from the address through an outside server If you have not been receiving these s, follow up with your IT department and ask them to put us on the whitelist We will also post information on the CAnswer Forum

36 Contact Us Let us know ASAP if: No patients are listed after logging into the web form A patient has evidence of metastatic disease prior to the surveillance start date so we can send a replacement patient Any problems with the web form Send an to specialstudy@facs.org Special Study staff will be checking the regularly and will answer your questions Always include Special Study ID in these s; do not send any PHI

37 Ticketing System s sent to will automatically generate a ticket Ticket status will be ed to registrar once created and with each update: Request: has not been opened by the study staff Opened: study staff working on the issue Need more user information: waiting on information from the registrar Closed: issue has been resolved Note: specialstudy@facs.org is a different address from the previous Special Study Different communication mechanism than 2015 Special Study (ticketing system vs. shared address ) This is the best way to get questions answered for the study

38 Instructions Electronic version can be found on the web form Physical copies should arrive via USPS by Friday 4/14/17 Sent to the attention of the Hospital Registrar Instructions are split into two sections General Web Form Instructions Prostate Study Instructions Structured in the order of how the data elements are listed in the web form

39 Webinars Webinars will be held weekly Participation is not mandatory but is suggested Webinar content will differ each week General updates, reminders, FAQs and helpful hints NCRA CE credit will be offered for the webinars 1.0 or 0.5 credit depending on length on webinars Recordings of the webinars will be available to view after each webinar Registration links for the webinars will be sent via

40 Website New Special Study section on the ACS website Webinars, documents, and announcements will be posted CAnswer Forum will be updated regularly

41 Questions?