Community Ambassador TOT January 29, 2014. Welcome and Purpose of Training.

Community Ambassador TOT January 29, 2014

Welcome and Purpose of Training

Welcome Participants!  Parkinson’s Disease Foundation  FORCE: Facing Our Risk of Cancer Empowered  Debbie’s Dream Foundation: Curing Stomach Cancer  Lung Cancer Circle of Hope  Easton Hospital  St. Luke’s Mountain States Tumor Institute  Thomas Johns Cancer Hospital  Moffitt Cancer Center  Beaumont Hospital Royal Oak  Hollings Cancer Center at the Medical University of South Carolina  Cancer Specialists of North Florida  Huntsman Cancer Institute  Cookeville Regional Medical Center  Komen  Montana Cancer Consortium  USC Norris Comprehensive Cancer Center  Kalispell Regional Healthcare  Sutter Institute for Medical Research

Agenda, Objectives and TOT Overview

Agenda  11:00-11:10Welcome and Purpose of Training  11:10-11:25Objectives, Agenda, TOT Overview  11:25-11:35Hope and Hesitations Introductions  11:35-12:15CCT Quiz Show  12:15-12:45Go-Rounds Practice (Offline)  12:45-1:15Go-Rounds Debrief  1:15-1:45BREAK  1:45-2:00Principles of Adult Learning  2:00-2:20Module Demonstration & Debrief  2:20-3:15Teachback Prep and Presentations (Offline)  3:15-4:00Teach Back Debrief Implementation Guide Walk-Through  4:00-4:20Training Customization  4:20-4:30Final Q & A, Next Steps

Objectives  Gain practical experience addressing common challenging questions about cancer clinical trials in a community setting  Identify key principles of adult education for community trainers  Practice delivery of Community Ambassador training content  Apply methods of customization to meet local community needs

About ENACCT  A non-profit organization founded in 2004  Our Mission: To improve access to cancer clinical trials through education and collaboration with communities, health care providers, and researchers  We seek to increase cancer clinical trial participation and access to quality care for all cancer patients—especially from underserved communities Closing March 2014

ENACCT Peer to Peer Training Enhance Community Literacy Primary Care Providers Clinical Trial Teams Community Leaders

Peer to Peer Training: Rationale  Leaders in the community who are known, trusted, and accountable can be effective and believable when discussing the pros and cons of clinical trials with other community members

Focus on Community Education vs. Patient Education  Optimal learning opportunity is prior to cancer diagnosis, planting seeds ahead of time for clinical trials awareness, availability and acceptability

What We Learned: “Buzz” Can Work! Number of Community trainers =53 Number of trainees =926 Number of workshops given by trainers n=65 Number reached through presentations by trainers n=4552 Community leaders trained were able to “spread the word” about CCTs  66% of those reached said they had spoken with at least one other person about CCTs   in clinical trial inquiry and “profiles” 68% said knowledge  in last year 40% said concern about raising awareness  in last year

What We Learned: Training Challenges  Continued engagement beyond training  Workshops were hard to schedule; format didn’t necessarily suit the needs of the community  Who to train; what’s the “action”  Motivating attendees to spread the word  Difficult subject to speak about in a “natural” way  Preparation of trainers a challenge  Difficult to motivate trainers in ongoing way  Evaluation- low response rate for community leaders

What We Learned: Community Engagement Challenges  Limited community coalition capacity  lack of local leadership and vision  Hard to weave CCTs into its work as a whole  Hard to create synergy among community leaders, PCPs and clinical researchers  Hard to both assess and address needed policy changes to reduce barriers  Evaluation –beyond accrual

Consider Evaluation and Sustainability Issues  Immediate:  How do we best evaluate what we’re doing? And what do we evaluate?  Long Term:  How to include CCT education into your outreach activities as a whole?  Continued engagement beyond training

Hopes and Hesitations

Hopes & Hesitations  What do you hope to get out of this training experience? What do you hope to learn?  What concerns or reservations do you have about talking to others about clinical trials?

JEOPARDY! I Can’t Believe It’s Not JEOPARDY!

What is the purpose of clinical trials? To ask specific scientific questions to find better ways to prevent, detect, or treat diseases or to improve care for people with diseases

What is the number one reason cancer patients participate in clinical trials? a.The doctor recommended it b. They saw an ad in the newspaper c.They did research on their own/found it on the internet a. The doctor recommended it

RL Comis, D. Colaizzi and J. D. Miller Cancer clinical trials (CCT) awareness and attitudes in cancer of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Vol 24, No 18S (June 20 Supplement), 2006: 6061

True or False? Cancer clinical trials are only for people who have no other options left. FALSE There are trials for all kinds of cancers, from the most advanced to the ones found very early.

Fact Clinical trials are not only for those patients with the most advanced disease; many patients get first line treatment through a clinical trial.

At first treatment, in the adjuvant setting, at recurrence… How can we ensure that every patient feels confident to ask, “is there a trial for me?”

True or False? New approaches being tested in clinical trials are probably more effective than the current or standard treatment. FALSE New methods may or may not be better than current treatment. A Phase 3 study goal is to determine whether there is a difference.

True or False? The reason clinical trials are done is that no one yet knows if a new treatment… 1.Is safe 2.Is effective 3.Will turn out to be better than the approaches currently being used TRUE These are also the three phases of clinical trials.

There Are 3 Phases of Clinical Trials Phase 1 trials Is it SAFE? Phase 2 trials Does it WORK? Phase 3 trials Is it BETTER than what is used now to treat this cancer?

True or False? Cancer clinical trials seek to find better types of cancer treatments FALSE There are many types of cancer clinical trials.

Fact: There are Many Types of Clinical Trials Treatment –Even as 1 st line Prevention/ chemoprevention –For primary or secondary cancer Diagnostic Genetics Quality-of-life/ supportive care Screening and early detection

There are different types of cancer clinical trials For people who have cancer –Treatment –Genetics –Quality-of-life/supportive care For people at high risk for getting cancer –Prevention –Genetics For people being screened for cancer Another way to look at it…

3 percent vs. 70 percent What is the percentage of adult cancer patients participating in cancer clinical trials vs. pediatric cancer patients?

More children 0-14 surviving cancer due to CCTs

Very Few People Participate Less than 3% of all cancer patients receive treatment through a clinical trial (20% eligible) –Participation rate is even lower among people of color, older people, and the medically underserved who tend to have higher cancer mortality rates than the population as a whole.

True or False? In randomized clinical trials, patients are assigned to different groups by an objective group of scientists and physicians. FALSE Patients are usually assigned through a computer. Neither the patients nor the doctors can choose the group they want.

In Many Clinical Trials, Participants Are Placed into Different Groups All have an equal chance to be assigned to one of two (or more) groups: One gets the most widely accepted treatment The other(s) gets the new treatment being tested, which doctors hope will be better

True or False? In cancer treatment trials, patients may be given a placebo instead of being appropriately treated for their cancer. FALSE Placebos are never used to substitute for appropriate medical care.

In cancer treatment trials, everyone gets treated –Placebos or “sugar pills” are almost never used instead of appropriate treatment Patients Are Always Treated for Their Cancer

Trial 123 Standard Treatment being studied

Trial 456 Standard & Placebo Standard & “Zing,” a treatment being studied

True or False? Patients who join clinical trials today aren’t going to benefit from taking part FALSE While it’s not yet known if the new treatment is going to work better than what is currently used, patients can and do benefit from participating.

 Open to many patients, even for first treatment –“The best management for any patient with cancer is in a clinical trial.” (NCCN, 2008) –“Therapies offered through CCTs should ideally be considered the preferred treatment choice for physicians and patients, if they are available” ( Institute of Medicine, 2010) Placebos never used instead of appropriate medical treatment Helping Individual Patients Today: A High Quality Treatment Option

Chance for survival, 1975-1977, all cancers: 50% Chance for survival, 1999- 2005, all cancers 68% The only way we will find better ways to treat cancer is through clinical trials… Also important for future patients

True or False? In general, doctors will always suggest cancer trials as a treatment option for a patient who is eligible. FALSE Both health care providers and patients lack knowledge about clinical trials.

Cancer Clinical Trials  Researchers “have difficulty” in recruitment and retention, especially among minority groups  Up to 30% of phase III trials close early  Referrals (or encouragement) from PCPs, surgeons and non-participating oncologists needs to be better  Poor understanding among patients and members of the public  Distrust, fear and suspicion

Most cancer patients are unaware that clinical trials were a treatment option Minorities may be as willing to participate in research but are less likely to be asked Consider the “narrow window” of opportunity Who is Offered the Opportunity to Participate?

What is the main purpose of a clinical trial protocol? a.To allow physicians to individualize each patient’s case b.To ensure high-quality patient care c.To describe how the study will be carried out d.None of the above c. To describe how the study will be carried out

This is something that ACA mandates… along with 36 states What is insurance coverage for patient costs in cancer clinical trials

Health insurance and managed care providers often do not cover the patient care costs associated with a cancer clinical trial. –What they cover varies by health plan and by study. 36 states currently mandate insurance coverage for these trials. Medicare covers many patient care costs in cancer clinical trials. Fact

The tragedy of the Tuskegee Study brought this right to all persons participating in any clinical trial. a.Randomized study design b.To be informed about risks c.Informed consent form d.Informed consent process

Why don’t more patients participate in clinical trials? a.Fear b.Don’t know about them c.Fear that it won’t be paid for by insurance d.Mistrust e.All of the above

Why are there restrictions as to who can participate on clinical trials? a.To protect patients safety b.To ensure study results are accurate and meaningful c.To limit trials to a certain number of participants d.Both a and b d. To protect patients’ safety and to ensure study results are accurate and meaningful

In the only study of 6000 cancer patients, this is the percentage that were actually informed about the possibility of receiving treatment through a clinical trial. What is 15%

20% of all cancer patients; 3% of all cancer patients; Who is eligible for CCT participation vs. who participates in CCTs?

What is the Informed Consent Process The process of providing all relevant information about the trial's purpose, risks, benefits, alternatives, and procedures to a potential participant.

Informed Consent They must be told about… The purpose The procedures The risks and potential benefits Their individual rights

FALSE 85% of cancer patients surveyed were uninformed that clinical trials were a treatment option; 75% of them would have been willing to participate True or False? In a national study of 6000 cancer patients, 85% were informed that clinical trials were a treatment option, but declined to participate.

True or False? Most patients are uninterested in participating in research FALSE

Almost Final Jeopardy Make Your Wager Now…

Name a barrier for clinical trials from the perspective of a) participating oncologist b) cancer patient c) primary care provider; d) non participating oncologist

Awareness Barriers/ Promoters Knowledge Attitudes/Beliefs Self-Efficacy Organizational Environment Health Literac y Opportunity Barriers/Promoters Provider Knowledge Provider Attitudes/Beliefs Eligibility/Exclusions by Design Access Medical Insurance Advanced Disease Co-morbidity Organizational Environment Acceptance/Refusal Barriers/Promoters Perceived Harms/Benefits Trust in Sponsor/Investigator Self-efficacy Altruism Religious Beliefs Personal Experience No Cost Treatment Financial Incentives Timing Opportunity Awareness Acceptance/ Refusal

Final Jeopardy Make Your Wager Now…

Name 3 risks and 3 benefits for patients who choose to take part in clinical trials

Final Jeopardy Possible Answers… BENEFITS Health care provided by leading physicians in the field of cancer research Access to new drugs and interventions before they are widely available Close monitoring of your health care and any side effects If the approach being studied is found to be helpful, patient may be among the first to benefit An opportunity to make a valuable contribution to cancer research

RISKS New drugs and procedures may have unknown side effects or risks New drugs and procedures may be ineffective, or less effective, than current approaches Even if a new approach has benefits, it may not work for all Final Jeopardy Possible Answers…

Offline Go-Rounds Practice 12:15-12:45

Go-Rounds Instructions  From your teams, assign a group leader who will pose questions to the rest of the team members who will take turns answering. The group leader should include themselves to answer a question from each station too and be time keeper  Group leader and team members should give each other feedback on their responses.  Larger group of 5 or more people onsite should break into 2 teams to complete all station questions

Team Assignments  Team A (Parkinson’s Disease Foundation/FORCE (Facing Our Risk of Cancer Empowered)  Team B (Debbie’s Dream Foundation: Curing Stomach Cancer)  605-475-4700 passcode 809901#  Team C (Lung Cancer Circle of Hope/ Easton Hospital)  Team D (St. Luke’s MtnStates Tumor Inst/Thomas Johns Cancer Hospital/Hollings Cancer Center at MUSC)  530-881-1200 passcode 448591#  Team E (Moffitt Cancer Center/University of Miami)  Team F (Cancer Specialists of North Florida/Huntsman Cancer Institute)  559-726-1000 passcode 691815#  Team H (Cross Cultural Health Care Program)  Team I (Cookeville Regional Medical Center)  530-881-1000 passcode 1091008#

Go-Rounds Debrief

BREAK 1:15-1:45

Principles of Adult Learning

Encouraging Group Participation  Maintain relaxed body language;  Use an icebreaker to help participants relax, get to know each other, and get ready to learn;  Set ground rules to help make the training a safe, comfortable, and productive learning environment;  Move around. If you stand behind a podium, you are likely to appear distant or inaccessible to participants;  Ask the group for examples to illustrate a point. This strategy ensures that examples are relevant to participants;  Bounce back to the group questions you receive from participants, as appropriate. “What do other people think about this?” and “What other ideas do you have?” are ways to show participants that you recognize their expertise; and  Show participants that you appreciate their contributions by saying things such as, “That’s a good point,” “Thank you for bringing that up,” or “Many people have that same question/concern Source: Adapted from CDC (1999). Training of Trainer’s Facilitator’s Guide. Atlanta, GA: Centers for Disease Control and Prevention.

Asking Open Ended Questions  Use to review information already covered.  “What new information have you learned in this training?”  “How will you apply what you’ve learned in this training to your work?”  Use to help participants share ideas, experiences, barriers, and solutions when you process activities or discuss contents.  “What are some of the barriers you have faced in discussing clinical trials with your patients?”  “How can you overcome these barriers you’ve identified?” Source: Adapted from CDC (1999). Training of Trainer’s Facilitator’s Guide. Atlanta, GA: Centers for Disease Control and Prevention.

Active Listening Verbal Active Listening Skills  Repeating what participants say to emphasize their points;  Rephrasing participants’ words to see if you understand what they are saying;  Connecting participants’ points to something covered earlier in the training;  Asking for clarification if you are not sure what participants mean; and  Thanking participants for their contributions. Nonverbal Active Listening Skills  Maintaining open, receptive body language;  Making eye contact with the speaker;  Leaning forward; and  Nodding when appropriate. Source: Adapted from CDC (1999). Training of Trainer’s Facilitator’s Guide. Atlanta, GA: Centers for Disease Control and Prevention.

Time Management  Make clear in setting ground rules that participants and trainers will be expected to respect starting, ending, and break times;  Help participants who wander off the topic to tie in their comments with the discussion at hand;  Ask participants’ permission to “park” questions, suggestions, or comments  Limit comments on any given topic. (Always encourage participants to continue their dialogue on breaks or after the training session.) Source: Adapted from CDC (1999). Training of Trainer’s Facilitator’s Guide. Atlanta, GA: Centers for Disease Control and Prevention.

Teaching Strategies  Small-group work  Case studies  Brainstorming  Lectures Source: Adapted from CDC (1999). Training of Trainer’s Facilitator’s Guide. Atlanta, GA: Centers for Disease Control and Prevention.

Working With Challenging Participants  Participant Who is Hostile, Negative, or Argumentative  Participant Who is Overly Talkative  Participant Who Says Something Incorrect  Participants Who Have Side Conversations  Participant Who Rambles  Participant Who Won’t Talk  Participant Who is Off Track Source: Adapted from CDC (1999). Training of Trainer’s Facilitator’s Guide. Atlanta, GA: Centers for Disease Control and Prevention.

Workshop Demonstration and Debrief

Key Tips About Cancer Clinical Trials Cancer clinical trials are an option in quality cancer treatment All patients should ask their doctor about cancer clinical trials Rights are protected of everyone who participates in research Everyone is affected by cancer © 2014 ENACCT, Inc. All Rights Reserved

Cancer in Underserved Communities  More likely to receive either:  No treatment, or  Treatment that does not meet current standards of care  Die from cancers that are preventable  Have died with cancers that could have been detected earlier © 2014 ENACCT, Inc. All Rights Reserved Shavers VL. J Natl Cancer Inst (2002); Tammemagi CM. Curr Opin Obstet Gynecol (2007); Edwards BK et al. J Natl Cancer Inst (2005); Clegg LX. Arch Intern Med (2002); Bach PB. N Engl J Med (2004); Jemal A et al. CA Cancer J Clin (2004); Gross C. Cancer (2008)

Cancer Clinical Trials…  Are research studies to find better ways to prevent, detect, or treat cancer  Help doctors find ways to improve cancer care  Are a quality cancer care option © 2014 ENACCT, Inc. All Rights Reserved

Who Benefits? The results of many trials help change the way cancer care is provided for everyone. BUT… – Less than 3% of all adults with cancer take part – Even fewer patients from racial and ethnic minority groups, who are over 65, or who are low income RESULT: Low participation=slower progress © 2014 ENACCT, Inc. All Rights Reserved

People Participate in Many Types of Cancer Clinical Trials For people who have cancer  Treatment  Genetics  Quality-of-life/supportive care For people at high risk for getting cancer  Prevention  Genetics For people being screened for cancer © 2014 ENACCT, Inc. All Rights Reserved

Patients Can’t Choose Their Treatment in a Cancer Clinical Trial All have an equal chance to be assigned to groups:  One group gets the most widely accepted treatment  The other group gets the new treatment being tested, which doctors hope will be better Patients cannot choose their group, and neither can the doctors © 2014 ENACCT, Inc. All Rights Reserved

We Have Protections Today Because of Abuses in the Past 20 th century abuses of human rights…. ◦In German concentration camps ◦In the Tuskegee Syphilis Study ◦With children and with the elderly ◦Among prisoners and the poor in Guatemala © 2014 ENACCT, Inc. All Rights Reserved

Protections Today: Informed Consent Process The purpose of the trial What will happen during the trial The risks and potential benefits Their individual rights Participants must be told about… © 2014 ENACCT, Inc. All Rights Reserved

There Are Benefits…  Patients are closely followed by doctors and nurses  If the new treatment being tested is proven to work, patients may be among the first to benefit © 2014 ENACCT, Inc. All Rights Reserved

And There Are Risks  New treatments are not always better than what is already used to treat cancer  Even if a new treatment has benefits, it may not work for everyone  May involve additional testing © 2014 ENACCT, Inc. All Rights Reserved NCI, 2005

Will There Be Extra Costs? Clinical trial participants must be told what the research costs will be and who will pay them during the consent process Clinical trials may have added costs –Research Costs –Patient Care Costs © 2014 ENACCT, Inc. All Rights Reserved

Key Facts About Cancer Clinical Trials Cancer clinical trials are an option in quality cancer treatment All patients should ask their doctor about cancer clinical trials Rights are protected of everyone who participates in research Everyone is affected by cancer © 2014 ENACCT, Inc. All Rights Reserved

There are Easy Ways to Find Available Trials in The Community Cancer Information Service 1-800-4-CANCER www.cancer.gov American Cancer Society 1-800-ACS-2345 www.cancer.org © 2014 ENACCT, Inc. All Rights Reserved

Teach Back Prep and Presentations 2:20-3:15

Prep and Presentation Instructions  15 minutes of teams preparation  2 teams will present workshop segment for 15 minutes each, followed by 5 minutes of debrief (20 minutes total for each team)  Presentation should include:  Brief opening, 8-10 slides, closing  Observers should consider points from teachback form to give teams feedback  Assign a time keeper to ensure switch of teams

Team Assignments  Team A (Parkinson’s Disease Foundation/FORCE (Facing Our Risk of Cancer Empowered)  Team B (Debbie’s Dream Foundation: Curing Stomach Cancer)  605-475-4700 passcode 809901#  Team C (Lung Cancer Circle of Hope/ Easton Hospital)  Team D (St. Luke’s MtnStates Tumor Inst/Thomas Johns Cancer Hospital/Hollings Cancer Center at MUSC)  530-881-1200 passcode 448591#  Team E (Moffitt Cancer Center/University of Miami)  Team F (Cancer Specialists of North Florida/Huntsman Cancer Institute)  559-726-1000 passcode 691815#  Team H (Cross Cultural Health Care Program)  Team I (Cookeville Regional Medical Center)  530-881-1000 passcode 1091008#

Purpose of Guide  Provide key tips, recommendations and strategies for planning and implementing the Community Ambassador Training of Trainers (TOT) and the Community Ambassador Workshop in local communities

Users of the Implementation Guide  Training Organizations (TO)  TOT Session Leaders **Trainers deliver Community Ambassador workshops using a separate Trainers Guide**

Steps to Training Implementation  Step 1-Orientation to Training Materials  Step 2-Identification of Trainers  Step 3-Training Needs Assessment and Content Customization  Step 4-Preparation for Training Delivery  Step 5-Training Evaluation

Training Materials  The Community Ambassador Training of Trainers (TOT) is designed for delivery to individuals recruited to become trainers. TOT content features:  (Optional) suggested icebreaker activities for introductions  Annotated Agenda and Training Section Talking Points  PowerPoint slides  Participant materials  Closing  (Optional) instructions for training evaluation

Training Materials  The Community Ambassador Workshop is designed for delivery to the general public. Delivery time of workshop content will vary, depending on inclusion of optional activities. Workshop content features the following:  (Optional) suggested icebreaker activities for introductions  (Optional) video clips for discussion  Trainer Guide with talking points (embedded in Implementation Guide)  PowerPoint slides  Participant materials  (Optional) Ziploc® Bag of Over the Counter Medicine (for icebreaker or workshop activity)  Group activities  Closing  (Optional) instructions for training evaluation

Training Grid  Time  Topic  Session Leaders  Process and Materials

Day 1 Opening  30 Minutes  Sign-in, (optional) pre-test evaluation  Welcome & Introductions  Agenda & Materials Overview  Group Norms  Parking Lot  Icebreaker

Cancer Clinical Trials Quiz Show  60 Minutes  Fun and interactive way to test trainers existing knowledge about clinical trials.  Clarify basic concepts-ask trainers to write lingering questions on sticky notes that can be placed in the parking lot.  Refer to trial referral flow chart as additional trainer resource  [Materials: Quiz Show Slides, Referral Flow Chart]

Closer Look at Trial Design and CCT Protocol  OPTIONAL  45 Minutes  Describe the purpose of randomization, stratification, and blinding in clinical trial protocols.  Materials: Trial Design and Protocol Sheets with Answer Key

Barriers to Clinical Trial Participation  30 Minutes  Trainers consider some of the most common barriers to clinical trial participation.  Trainers break into small groups of 3-4 to evaluate barrier strips and then place up on flipchart sheets with major barrier categories on the wall. 10-15 min small group work, then 10-15 minute large group debrief.  [Materials: Barrier Strips, Flip Chart Paper]

Costs and Insurance Coverage  OPTIONAL  Group brainstorming to categorize patient care costs vs. research costs  Use matching activity handout to provide overview of what’s happening with Medicare, Medicaid, and coverage under the Affordable Care Act  Game to categorize patient care costs vs. research costs  [Materials: Costs and Coverage Sheets]

Patient Protection and Ethics in Research  45 Minutes  Describe current methods of participant protection implemented throughout the research process  Review key historical events regarding past abuses in clinical research  Materials: Patient Protection Sheets with Answer Key

Common Questions About Clinical Trials-Go Rounds Activity  60 Minutes  Break into groups of 3-4, rotating across question stations around the room in 10-15 minute increments. Allow time for each groups to circulate to all of the stations.  Use 15 minutes to debrief groups on the activity.  [Materials: Go-Rounds Question Sheet, Common Questions About Cancer Clinical Trials Sheet]

Day 1 Wrap Up and Closing  30 Minutes  Ask the group what key messages from the day are  Address questions and items on the parking lot.  Review teach back team assignments  Homework: Review Common Questions Handout  [Materials: Team Assignment Sheet]

Day 2 Opening  20 Minutes  Welcome group back  Recap Day 1 learning  Review Day 2 agenda

Workshop Demonstration and Debrief  40 Minutes  Refer to the training checklist used during teach backs  Debrief demonstration: How do you rate how well we demonstrated these skills?  [Materials: Trainer’s Guide, Teachback Observation Forms]

Principles of Adult Learning  30 Minutes  Encouraging Group Participation  Time Management  Teaching Strategies  Working with Difficult Participants

Presentation Prep Time for Teams  30 Minutes  Review Trainer Teams Assignment  Instruct teams to prepare with each other to deliver a 15 minute mock training  Instruct trainers that they should pretend to do the warm up and introduction, and go through rest of the presentation talking points normally

Team Presentations  40-80 Minutes  Presentation and Peer/Observer Feedback  Note: Additional teams should be assigned to other rooms. Session leaders should split up to serve as observers of presentations in each designated space.  [Materials: Teachback Observation Form]

Group Debrief of Presentations  30 Minutes  Reflect on what experience was like for participants  Identify areas for additional practice

Trainer Roles and Responsibilities  20 Minutes  Review expected trainer roles and responsibilities  Refer to Trainer Preparation Timeline  Begin brainstorming on venues for workshop delivery

Day 2 Closing  Provide final instructions regarding further follow-up with trainers  Conduct closing activity  Collect completed post-tests (optional)

Trainer Recruitment  Typically, trainers are representatives in the community who are known, trusted, and accountable  can be effective and believable when discussing the pros and cons of clinical trials with other community members.  Consider whether you are…  a community organization or cancer care institution with existing community representatives that are in your group  seeking to recruit additional volunteers or you are a cancer care institution that needs to identify trainers from the community?  Guide defines important characteristics for all identified trainers

Recommended Trainer Skills  Be comfortable and have experience with public speaking  Be comfortable using computers (i.e. use of Power Point slides, LCD projector, email, etc.)  Be able to read and communicate in the language that the training content will be delivered in (Note: all materials and video clips provided with this guide are in English)  Be an active participant or have a relationship with one or more local community based organizations  Be willing to approach community organizations leaders to schedule presentations  Have a reliable means of transportation for travel to training sites  Be committed to deliver training over at least a 1 year period

Training Needs Assessment and Content Customization  Learning and Feedback  Palm Cards  Video Clips  Training Group Assessment  Hybridization of the TOT Training Delivery

Community Bridges  Partnership with 5 African American CBOs and UNC Chapel Hill  Recalibrated curricula into three new presentations  220 adult African American volunteers participated in one of three CCT education modules  Pre and post-test responses of each module showed significant increases in participant knowledge about trials (p < 0.001) and awareness of CCT sites (p < 0.001) in their communities

Center for Asian Health  22 Asian community representatives were recruited as community health educators (CHEs) who received 12-hour training on clinical trial education. Among 11 Chinese community organizations 247 individuals enrolled and participated in the clinical trial education delivered by trained CHEs.  Participants completed pre-test before and post- test after the intervention. Results: Fifteen out of 21 measures of clinical trial knowledge showed significant changes post the intervention (p<.05).

Training Preparation Timeline  8-12 Weeks in Advance  6-8 Weeks in Advance  2-3 Weeks in Advance  Week in Advance  Training Day  1-3 Days after Training

Training Evaluation  Pre and post surveys for both trainers and trainees, measuring changes in knowledge, attitudes, and beliefs about cancer clinical trials  To measure longer term impact, TOs may also want to consider use of a post-post evaluation with participants 3-6 months following training  Where applicable, obtain IRB approvals to collect evaluation data.  As training content is modified to address community needs, review evaluation questions to make adjustments as necessary.  Ensure accurate data collection  Designate a co-trainer or site host to assist you in collecting back completed evaluation forms at the conclusion of the session

Final Q & A/ Next Steps

Community Ambassador TOT January 29, 2014. Welcome and Purpose of Training.

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Community Ambassador TOT January 29, 2014. Welcome and Purpose of Training.

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