CPAC Rectal Cancer Project

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CPAC Rectal Cancer Project (2014-2017)

Funded by Canadian Partnership Against Cancer (CPAC) Quality improvement project 8 centres across Canada Build multidisciplinary community of practice (COP) to

share best practices Reduce unwarranted variation Identify gaps in care Implement strategies to close gaps

This is not QuickSilver!

QuickSilver Study Phase II study assessing safety and feasibility of

using MRI criteria to identify “good prognosis” Stage II and Stage III rectal cancer patients eligible for primary surgery

17 centres across Canada Start up meeting June 2013 Recruitment October 2014 to June 2015

Webinar Outline

1.Study Overview 2.Review of process indicators and suggested tools for data capture

Pathology Radiology Radiation Oncology Surgery Multidisciplinary Cancer Conference

3.Next Steps and Wrap Up

Objectives - CPAC Rectal Cancer Project

1. Accelerated diffusion implementation: Preoperative staging with MRI Multidisciplinary Cancer Conference (MCC) High quality radiotherapy and surgical care High quality pathologic assessment

2. Select and measure process indicators3. Identify gaps in care4. Implement strategies to close existing gaps

To develop a multidisciplinary, pan Canadian Community Of Practice to improve the overall quality of rectal cancer care:

Year 1 Year 2 Year 3

National Workshop(May 23, 2014)

Select and finalize process indicators for each quality initiatives

Identify areas for knowledge translation

Implementation Phase(April 1, 2015 to Dec 31, 2016)

• Audit and Feedback • Measure selected process indicators every 3 months• Generate report (total 7 reports)• Identify gaps and work towards closing gaps• Continue knowledge translation activities on an institutional level

Planning Phase(June 1, 2014 to March 31, 2015)

Finalize Project Report Template with final process indicators

Develop tool kit to assist centres capture process indicators

• MRI protocol• Synoptic MRI report • Radiation Oncology Pre-Treatment Checklist• Radiation Oncology Treatment Summary• Synoptic OR Report• Pathology Protocol• Pathology CAP Checklist

• Develop knowledge translation activities at COP level:

Radiology Training Set Radiation Oncology Contouring WebinarPathology List Serv (EMVI)

• Study website and database development

• Hire coordinators at each centre (Jan 2015)

FOCUS ON

DETAILS

AGREE WITH CONCEPT

FIX THE PROBLEM

Apr 2014 - Mar 2015 Apr 2015 – Mar 2016 Apr 2016 – Mar 2017

END PRODUCTS

A multidisciplinary model to improve quality of care for rectal cancer participating centres will be able to take

lead to disseminate model in respective provinces

Development of a well coordinated COP Continue to work together on projects

including grant capture and trials

INFRASTRUCTURE AND COMMUNICATION

Site LeadsLocation Surgery Site Leads Pathology Site Leads Radiology Site Leads Radiation Oncology Site

LeadsMedical Oncology Site

LeadsVancouver, BC

Carl Brown St. Paul’s Hospital

Doug Filipenko St. Paul’s Hospital

Patrick Vos St. Paul’s Hospital

John Hay BC Cancer Agency

TBA

Calgary, AB Tony MacLean Foothills Medical Centre

Vincent Falck Foothills Medical Centre

Deepak Bhayana Foothills Medical Centre

Corinne Doll Tom Baker Cancer Centre

Patricia Tang Foothills Medical Centre

Winnipeg, MB

David Hochman St. Boniface

Jose Gomez St. Boniface

Iain Kirkpatrick St. Boniface

Shahida Ahmed Cancercare Manitoba

TBA

Toronto, ON

Erin Kennedy Mount Sinai HospitalRobin McLeod Cancer Care Ontario

Richard Kirsch Mount Sinai Hospital

Kartik Jhaveri University Health NetworkSeng Thipphavong University Health Network

Charles Cho Southlake Regional Health Centre

Monika Krzyzanowska Princess Margaret Cancer Centre

Toronto, ON

Nancy Baxter St. Michael’s Hospital

Cathy Streutker St. Michael’s Hospital

Anish Kirpalani St. Michael’s Hospital

Charles Cho Southlake Regional Health Centre

Christine Brezden-Masley St. Michael’s Hospital

Montreal, QUE

Sender Liberman MUHC-Montreal General Hospital

Vicky Marcus MUHC-Montreal General Hospital

Caroline Reinhold MUHC-Montreal General HospitalGiovanni Artho MUHC-Montreal General Hospital

Neil Kopek MUHC-Montreal General Hospital

Jamil Asselah MUHC-Montreal General Hospital

Quebec City, QUE

Sébastien Drolet Hôpital St-François D'Assise

Martine Perigny CHUQ-Hotel-Dieu de Quebec

Stanislas Morin CHUQ-St-Francois d'Assise

Andre-Guy Martin CHUQ-Hotel-Dieu de Quebec

TBA

Halifax, NS Lara Williams Queen Elizabeth II Health Sciences Centre

Heidi Sapp Queen Elizabeth II Health Sciences Centre

Sharon Clarke Queen Elizabeth II Health Sciences Centre

Nikhilesh Patil Nova Scotia Cancer Centre

Bruce Colwell Queen Elizabeth II Health Sciences Centre

Selection of Process Indicators

Review of pre-workshop survey Suggested process indicators were rated scale of 1-5 based on clinical

importance

National Workshop Attended by 35 Site and Project Leads; representation from all 8 centres

Discussion of each specific item Pre-meeting survey results Best available evidence Expert opinion

Final vote to include/exclude each specific item Anonymous; all specialties

Selection of Process Indicators

Results of the final vote reviewed by Investigative Team and Project Leads

Process indicators for which >90% of workshop participants voted to include were kept

Final vote results and final process indicators selected were distributed to meeting participants for final feedback

Suggested Tools and Strategies for Data Capture of Process Indicators

Selected tools and strategies to facilitate data capture based on: Final process indicators selected Multidisciplinary discussion at the national

workshop Current best practices at participating

centres Expert and consensus opinion

Suggested Tools and Strategies for Data Capture

Introduce tools selected to facilitate data capture of process indicators

Suggest how tools may be implemented at each centre Pathology – David Driman Radiology – Laurent Milot Radiation Oncology – Charles Cho Surgery – Lara Williams MCC – Sender Liberman

Each presentation 10 minutes followed by 5 minutes of questions Focus questions on suggested tools and implementation Please direct questions about specific process indicators off line to Site or Project

Leads

KEEP IN MIND

All centres receive $2000/site for project launch All centres encouraged to modify tools or develop new

tools to meet their specific institutional needs All centres to start implementing their plan as soon as

possible All centres receive $60,000/2 years for a research

coordinator All Site Leads will receive a workbook with relevant

documents and worksheet to complete (end of November)

Example WorksheetMSH EXAMPLE

What are our group’s priorities? • Synoptic OR Report (currently narrative)• Synoptic MCC Report (currently no report

issued)What are our goals?

• 80% MCC and OR report synoptic

How will our group achieve these goals? • Review and use OR and MCC synoptic report developed

What are the main barriers to implementing this plan?

• Surgeons don’t want to dictate MCC discussion due to time constraints

• Seem to be ok with synoptic OR reportWhat strategies are required to overcome these barriers?

• Surgeons seem to be ok with signing a paper copy of synoptic MCC report filled in by MCC chair

• Surgeons ok using a laminated card with synoptic OR note headings

Example WorksheetMSH Example

What is the final implementation strategy?

• MCC chair will complete MCC report on “duplicate form” for the treating physician to sign and place in chart

• Distribute laminated cards with synoptic OR report; Site Lead to investigate possibility of developing macro via hospital transcription centre

How will we evaluate if our goals have been met?

• % of reports in synoptic format

What resources are required? • Synoptic reports, duplicate paper, access to lamination service

What is the time-line (start-date)? • Start-date is January 2015 • 25% synoptic @ 3 months • 50% synoptic @ 6 months• >80% synoptic @ 12 months

Pathology Process Indicators YOUR

CENTREALL

CENTRES

1 Quirke method used Y/N % Yes

2 At least 3 tumour containing blocks with deepest invasion (all including CRM if possible) + 1 additional block of CRM if not included in deepest invasion blocks % Yes

3 At least 2 tumour containing blocks with closest serosal surface (where applicable for upper rectal cancers) % Yes

4 Assessment of TME quality % Yes

5 Documentation of minimum distance of tumour to CRM % Yes

6 Documentation of presence of venous (large vessel) invasion – intramural/extramural % Yes

7 Pathology report in synoptic format % Yes

8 Pathology report includes all CAP checklist mandatory elements % Yes

CPAC Pathology – Gross Protocol

Specimens grossed as per method of Quirke et al 3-5 mm slices through fixed, unopened specimen

at least 3 tumour blocks with deepest invasion (CRM where applicable)+ additional tumour block if not already included

at least 2 tumour blocks with closest serosal margin (where applicable)

Macroscopic assessment of quality of the TME complete, nearly complete, incomplete

CPAC Pathology – Reporting

1. College of American Pathologists (CAP) checklist - all mandatory elements

2. College of American Pathologists (CAP) checklist - non-mandatory elements Assessment of TME quality Treatment effect following neoadjuvant chemoradiotherapy

3. Non CAP Elements Documentation of Quirke method At least 3 tumour blocks with deepest invasion

+ 1 tumour block of CRM if not already included At least 2 tumour blocks with closest serosal surface Closest distance of CRM in mm (all cases, even when not the closest margin) Venous (large vessel) invasion – intramural and extramural

4. Synoptic Format

CPAC Pathology – Practical Issues

Process indicators, protocol and report all selected because of their effect on quality of processes and patient outcomes

A detailed protocol has been developed for each centre to use as a guide

Each centre to determine the best way to implement locally

Report formats can be modified as needed

All process indicators will be collected from the pathology report

CPAC Pathology – KT Initiative Venous invasion selected for KT initiative VI detection, reporting discussed at national meeting Encourage use of routine elastin staining UK guidelines (July 2014) recommend that VI should be

detected in at least 30% of resection specimens Data from reports used to provide audit and feedback to each

centre about VI detection rates Encourage implementation of initiatives to improve detection

rates if gaps exist

CPAC MRI Process Indicators YOUR

CENTREALL

CENTRES 1 # Pelvic MRI

% Yes

2 MRI Protocol meets minimum MERCURY criteria

Minimum Resolution Form

3 MRI report in synoptic format

% Yes

4 Assessment of T-category

% Yes

5 Assessment of mesorectal lymph nodes

% Yes

6 Assessment of distance to the MRF

% Yes

7 Assessment of extramural venous invasion (EMVI)

% Yes

8 Assessment of distance of lower extent of relative to tumour to anal verge

% Yes

9 Assessment of relationship of tumour to anterior peritoneal reflection

% Yes

10 Assessment of distance from the top of the puborectalis sling to the lower extent of tumour

% Yes

11 Percent agreement between MRI and pathology for distance to the MRF/CRM (+/- 1 mm) % Yes

CPAC MRI Protocol

MRI protocol as per MERCURY 1.5T or 3.0T magnet with phased array coil (NO endorectal coil) Includes four fast-spin echo, T2-weighted sequences without fat saturation High resolution, axial oblique T2 sequences REQUIRED (Sequence 3 and 4)

Optional: T1 sequences and Diffusion Weighted Imaging Gadolinium Bowel preparation Rectal contrast Antiperistaltic agents

Sequence Imaging plane TR/TE FOV (cm) Section thickness (mm) Matrix size ETL NSA

1 Sagittal 2500-5000/85 24 5-0 512x256 8 2

2 Axial 4000/85 24 5-0 512x256 8 2

3 Oblique axial 4000/85 16 3-0 256x256 8 4

4 Coronal oblique 4000/85 16 3-0 256x256 8 4

CPAC Minimum Resolution Requirement

Terminology within protocol can be challenging to interpret matrix size may be specified as "256 x 128" if there are 128 phase-encoding

steps but parallel imaging is used with an acceleration factor of 2 the spatial resolution would meets requirements however the spatial

resolution implied by the scan parameters Minimum Standard of Resolution Form to be completed by Radiology Site Lead

at each centre to ensure that MRI protocol meets this minimum standard of resolution

Each Radiology Site Lead encouraged to work with vendor to verify compliance with protocol

Better resolution (i.e. fewer millimetres per pixel) is acceptable provided SNR is adequately preserved Generally possible on 3T but harder to accomplish on 1.5T due to time

constraints

Benefits of Synoptic MRI Report

Implemented across Ontario in 2009 via Radiology webinar and endorsement by Cancer Care Ontario

A pre and post-implementation audit of 100 MRI reports issued across Ontario showed: Increase in uptake from 0% to 43% Increase in completeness from 40% to 79% Increase in completeness with synoptic compared to

narrative format, 95% versus 67% Increase in distance to to MRF with synoptic compared to

narrative format, 84% versus 46%

Synoptic MRI Report4. DISTANCE TO THE MRF AND EXTRAMURAL DEPTH OF INVASION (EMD) i) Shortest distance of the definitive tumour border to the MRF (not including spiculations) = ________ mm [or unable to estimate] or not applicable (involving the peritonealised portion of the rectum or T4a)] [Record not applicable for T1 and T2 tumours] ii) Extramural depth of invasion (EMD) at most penetrating part of tumour (not including spiculations) =_______ mm

[May be at a different location than shortest distance to the MRF. Record 0 mm for T1 and T2 tumours]

iii) Are there any spiculations closer to the MRF? No Yes* *If yes, please specify distance = ________ mm and location __________________ (on clock face)

5. EXTRAMURAL VENOUS INVASION (EMVI) EMVI: Absent Equivocal Present If present, shortest distance of the EMVI to the MRF = __________ mm 6. MESORECTAL LYMPH NODES AND TUMOUR DEPOSITS Any suspicious mesorectal lymph nodes and/or tumour deposits ? No Yes* (suspicious = irregular border, mixed signal intensity and/or > 8 mm) *If yes: (please complete a and b)

(a) Shortest distance of any suspicious mesorectal lymph node/tumour deposit to MRF = _______ mm (b) Please indicate location of the lymph node/deposit closest to the MRF:

At level of tumour; at ___________ o’clock Above tumour; at ______________ o’clock Below tumour; at ______________ o’clock 7. EXTRAMESORECTAL LYMPH NODES Any extramesorectal lymph node(s) with suspicious morphology or signal? No Yes* (suspicious = irregular border, mixed signal intensity and/or > 1 cm) * If yes, please specific location (free text): 8. FREE TEXT/ADDITIONAL COMMENTS

1. MRI PROTOCOL

Overall image quality: Adequate Suboptimal Non-diagnostic Magnet: 1.5T 3.0T 2. TUMOUR HEIGHT Distance from the anal verge to lower extent of tumour:

Low (0-5.0 cm) Mid (5.1-10.0 cm) High (10.1-15.0 cm)

Relationship of the tumour to sacral promontory and anterior peritoneal reflection:

Proximal extent of tumour below sacral promontory and distal extent of tumour above or just at peritoneal reflection Proximal extent of tumour below sacral promontory and distal extent of tumour at/below peritoneal reflection Proximal extent of tumour below the peritoneal reflection

Distance from the top the of puborectalis sling to distal tumour margin: ______ cm [0 cm if involved and negative integer if below]

3. T-CATEGORY T1/early T2* Definite T2 T2/early T3 Definite T3 T3 possible T4* Definite T4* (indicate all involved structures)

For low rectal tumours (0- 5 cm), please characterize the component at or below the puborectalis sling: [Please note this does not reflect the AJCC staging system] Level 1 - Submucosa only, no involvement of the internal sphincter Level 2 - Confined to the internal sphincter, no involvement of the intersphincteric fat Level 3 – Intersphincteric fat involved – INTERSPHINCTERIC PLANE NOT SAFE Level 4 – Involves external sphincter or beyond – INTERSPHINCTERIC PLANE NOT SAFE

CPAC MRI KT Initiative

Radiology Training Set developed by Dr Gina Brown Available on study website in January 2015 Encourage all participating radiologists to complete 3

MRI reports on-line Receive Gina Brown’s report to compare your results

and access to Gina Brown for questions via an internet chat room

Focus on distance of MRF, EMVI, low rectal cancer, anterior peritoneal reflection

CPAC Radiation Oncology Process Indicators YOUR CENTRE ALL CENTRES

1 # receiving preCRT

% Yes

2 # receiving post CRT

% Yes

3 Institutional protocol available

Yes/No

4 Planned target volume (PTV) is peer reviewed

% Yes

5 Organs at risk is peer reviewed

% Yes

6 Use of blocks and MLC shielding is peer reviewed

% Yes

7 Portal imaging at least once per week

% Yes

8 Treatment summary documents delivered dose and fractionation % Yes

9 Treatment summary includes technique

% Yes

10 Treatment summary includes start date

% Yes

11 Treatment summary includes completion date % Yes

12 Treatment summary includes delay/disruption in treatment for any reason % Yes

13 Treatment summary includes length of treatment interruption (total # days) % Yes

CPAC Radiation Oncology Process Indicators

Process indicators selected because of their effect on quality of processes and patient outcomes

Significiant variation in technique across centres Peer review of treatment plans is strongly encouraged

and may become mandatory Pre-Treatment Checklist developed to document peer

review process Treatment Summary developed to document

treatment details including delivered dose, technique and interruptions in treatment

CPAC Radiation Oncology Process Indicators

Each centre to determine the best way to implement these initiatives locally at their institution

Report format can be modified to best suit needs of each centre

All process indicators will be collected from the Pre-Treatment Radiation Oncology Checklist and the Treatment Summary Form

Both are short, one page forms with check box format Free text allowed

Pre-Treatment Checklist CommentsTechnique

IMRT 3D Conformal Field Based

Dose/Fractionation

4500cGy/25 fx 5000cGy/25 fx 2500cGy/5fx Other:

Boost Planned Yes No

Positioning

Supine Prone without belly board Prone with belly board board

Anal marker at anal verge Yes No

CT or MRI Simulator with < 5 mm slice thickness Yes No

Planned target volume is peer reviewed Yes No

Organs at risk (OAR) is peer reviewed Yes No

Hot spots are peer reviewed Yes No

Documentation of rationale if PTV or OAR does not meet criteria for institutional dose distribution

Yes No

Use of blocks/MLC shielding is peer reviewed Yes No

Peer review is completed prior to start of radiotherapy Yes No

Peer review includes medical physicist

Yes No

Peer review includes radiation technologist Yes No

Frequency of portal imaging

Daily Weekly Other

Treatment Summary1. Date of dictation (DD/MM/YYYY): _______________________

2. Technique: Field based 3D Conformal IMRT

3. Delivered doses and fractionation: 4500cGy/25fx 5000cGy/25fx 2500cGy/5fx Other (please specify): _____________________________

4. Chemotherapy:

Bolus 5FU Infusional 5FU Capecitabine

Other (please specify): ___________________________________

5. Radiotherapy start date (DD/MM/YYYY): _______________________

6. Radiotherapy completion date (DD/MM/YYYY): __________________

7. Interruption of radiotherapy for any reason (check all that apply): Diarrhea Nausea Hand-foot skin reactions Vomiting Mucositis Perineal desquamation Dehydration Neutropenia Thrombocytopenia Fever Febrile neutropenia Other (specify): _________________

8. Total number of days of interruption break in radiotherapy: < 4 days 4 to 14 days > 14 days

9. Interruption of chemotherapy for any reason (check all that apply): Diarrhea Nausea Hand-foot skin reactions Vomiting Mucositis Perineal desquamation Dehydration Neutropenia Thrombocytopenia Fever Febrile neutropenia Other (specify): _________________

10. Total number of days of interruption break in chemotherapy: < 4 days 4 to 14 days > 14 days

11. Free text:

______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Radiation Oncology KT Initiative

Recent studies to suggest significant variation in contouring

Planning KT initiative to review current contouring guidelines and assess variation in contouring across centres

Webinar to discuss results, review current guidelines and develop Canadian guideline and develop strategies to minimize variation

Surgery Process Indicators

YOUR CENTRE

ALL CENTRES

1 Pre-operative CEA % Yes 2 Pre-operative CT abdo/pelvis % Yes 3 Pre-operative chest imaging (CXR or CT chest) % Yes

4 Pre-operative endoscopy % Yes 5 Pre-operative local staging (MRI or TRUS) % Yes 6 Presentation at MCC % Yes

PRE-OPERATIVE ASSESSMENT PROCESS MEASURES

SURGICAL PROCESS MEASURES

YOUR CENTRE

ALL CENTRES

1 Pre-operative marking by stoma nurse when applicable % Yes 2 OR Report in Synoptic Format % Yes 3 Documentation of distance from anal verge to lower extent of tumour % Yes 4 Documentation of rationale for APR % Yes 5 Unplanned return to OR within 30 days % Yes

Benefits of Synoptic OR Report

WebSMR shown to significantly increase the completeness of OR report

Current used in Alberta, Manitoba and Nova Scotia Uptake low with only 22% of rectal cancer surgeries

registered Likely due to large number of data elements required Modified version of BC Cancer Agency Rectal Cancer

Surgery Checklist 21 items Developed to capture all CPAC surgery process indicators

CPAC Synoptic OR Report

CPAC Surgery Process Indicators and Report

Process indicators and report selected because of their effect on quality of processes and patient outcomes

Synoptic OR report developed as a guide for use at each centre

Each centre determine the best way to implement locally at their institution

Report format can be modified to best suit needs of each centre

All surgery process indicators will be collected OR report

All pre-operative process indicators will be collected from clinical notes in patient chart

CPAC MCC Process Indicators YOUR

CENTREALL CENTRES

1 # presented at MCC % Yes

2 Imaging based T-category % Yes

3 Imaging based N-category % Yes

4 # of MCC sessions over 3 months #

5 # of sessions attended by 1 or more surgeons over 3 months # (%)

6 # of sessions attended by 1 or more radiologists over 3 months # (%)

7 # of sessions attended by 1 or more medical oncologists over 3 months # (%)

8 # of sessions attended by 1 or more radiation oncologist over 3 months # (%)

9 # of sessions attended by pathology # (%)

10 MCC attended by at least one treating physician (surgery, radiation oncology, medical oncology)

% Yes

11 MCC report issued % Yes

12 MCC report dictated by treating physician % Yes

13 MCC report includes attendance by specialty(surgery, radiology, radiation oncology, medical oncology, pathology)

% Yes

14 MCC report includes treatment recommendation % Yes

15 MCC report includes rationale for treatment recommendation % Yes

Benefits of MCCs

Perceived by health care professionals as improving communication (Devit 2010)

Patients are more likely to receive treatment according to guidelines (McDermid 2009)

Treatment plans will change up to 43% after MCC discussion (Santoso 2004)

May lead to improvements in survival (Prades, 2014)

Results of MCC for Primary Rectal Cancer

Re-interpretation of MRI Tumour Factors TOTAL

preRT to Primary Surgery

3 4 7

Primary Surgery to preRT

1 3 4

Primary Surgery to Chemotherapy

1 1 2

TOTAL 5 8 13

31% (13/42) change in initial treatment modality

100% compliance with MCC treatment recommendations

Positive CRM rate = 5.5% (2/36)

Synoptic MCC Report Synoptic MCC report designed to capture selected

process indicators Quality of MCC Quality of MCC report Compliance with MCC treatment recommendation

One page in length with check box format Free text allowed Format can be modified to suit needs of each centre Can be completed by MCC Chair and reviewed by

treating physician

CPAC Synoptic MCC Report

MCC Suggested KT Initiative In addition to study outcomes:

Quality of MCC Quality of the MCC report Compliance with MCC treatment recommendation Complete TME and positive CRM rate

Encourage each centre to assess the change in the initial treatment modality over a six month time period during the study

SUMMARY AND NEXT STEPS Site Leads at each centre to launch project locally

($2000 per site) Review process indicators and best local strategies

to ensure capture of the indicators Surgical Site Leads to ensure REB and DSA complete

Transfer of $30K (Jan 2015 and Jan 2016) Hire coordinator (consider using pre-existing

coordinators)

SUMMARY AND NEXT STEPS

Start to implement initiatives as soon as possible Patient recruitment/data collection begins April 1,

2015 (first report July 2015) Regular teleconference last Tuesday every other

month starting January 27th Newsletter with meeting minutes Website for on-site data collection Webinar for research coordinators in March 2015 to

review definitions/terms for data collection

THANK YOU!

1. REB/DSA (Surgical Site Lead)

2.Hire Coordinator for January 2015 (Surgical Site Lead)

3.Project Launch as soon as possible (All Site Leads)

4.Complete Worksheet (All Site Leads)

5.Next teleconference: (All Site and Project Leads)

Tuesday January 27th from 4:30-5:30 pm EST