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 11:00-11:10 Welcome and Purpose of Training
11:10-11:25 Objectives, Agenda, TOT Overview
11:25-11:35 Hope and Hesitations Introductions
11:35-12:15 CCT Quiz Show
12:15-12:45 Go-Rounds Practice (Offline)
12:45-1:15 Go-Rounds Debrief
1:15-1:45 BREAK
1:45-2:00 Principles of Adult Learning
2:00-2:20 Module Demonstration & Debrief
2:20-3:15 Teachback Prep and Presentations (Offline)
3:15-4:00 Teach Back Debrief Implementation Guide Walk-Through
4:00-4:20 Training Customization
4:20-4:30 Final 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
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 & 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?
I Can’t Believe It’s Not JEOPARDY!JEOPARDY!
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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
I Can’t Believe It’s Not JEOPARDY!JEOPARDY!
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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
I Can’t Believe It’s Not JEOPARDY!JEOPARDY!
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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?”
I Can’t Believe It’s Not JEOPARDY!JEOPARDY!
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True or False? New approaches being tested in clinical trials are probably more
effective than the current or standard treatment.
FALSENew methods may or may not be better than
current treatment.
A Phase 3 study goal is to determine whether there is a difference.
I Can’t Believe It’s Not JEOPARDY!JEOPARDY!
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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
TRUEThese 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?
I Can’t Believe It’s Not JEOPARDY!JEOPARDY!
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True or False? Cancer clinical trials seek to find better types of cancer treatments
FALSEThere are many types of cancer clinical
trials.
Fact: There are Many Types of Clinical Trials
• Treatment– Even as 1st 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…
I Can’t Believe It’s Not JEOPARDY!JEOPARDY!
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3 percent vs. 70 percent
What is the percentage of adult cancer patients participating in cancer clinical trials
vs. pediatric cancer patients?
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.
I Can’t Believe It’s Not JEOPARDY!JEOPARDY!
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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
I Can’t Believe It’s Not JEOPARDY!JEOPARDY!
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400 400 400 400 400 400
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
I Can’t Believe It’s Not JEOPARDY!JEOPARDY!
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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
d. Informed consent process
Why don’t more patients participate in clinical trials?
a. Fearb. Don’t know about them
c. Fear that it won’t be paid for by insurance
d. Mistrust
e. All of the above
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
FALSE85% 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.
Name a barrier for clinical trials from the perspective of a) participating oncologist b)
cancer patient c) primary care provider; d) non
participating oncologist
1 Kinney, A. Y., Richards, C., Vernon, S. W., & Vogel, V. G. (1998). The effect of physician recommendation on enrollment in the Breast Cancer Chemoprevention Trial. Prev Med, 27(5 Pt 1),713-719.
Patient and Physician Barriers to Clinical Trial Access (Source: Cancer Clinical Trials: A Guide for Outreach and Advocacy (NCI) (Unless Otherwise Noted)
Physician Barriers Patient and Environmental Barriers
A physician’s recommendation is often the primary factor influencing patients’ decisions to enroll in a trial.1 Yet, each group of providers involved in patients’ diagnosis and treatment face unique barriers to facilitating patient access to clinical trials. For all Patients For Medically Underserved
Groups in particular *
Participating Oncologists
Non participating Oncologists/ Surgical Oncologists
Primary Care Providers doing diagnostic workup, prior to referral 2
May not offer treatment through a clinical trial to all that would otherwise qualify by: assuming disinterest on the part of
their patients inadvertently discriminating against
older people or the medically underserved3, 4,5
avoiding the subject out of concern they would be seem as insensitive.
May not have the skills, ability or resources to conduct appropriate recruitment within the community6.7 May feel the extra effort required to consent minority patients or the medically underserved is not important for their research.8
May lack awareness of appropriate local clinical trials
May be unwilling to “lose control” of a person’s care
May believe that standard therapy is best, or
May feel that referring to or participating in a clinical trial adds an excessive administrative or cost burden to the practice.
May not feel suited to discuss the topic with patients.9 May lack awareness of appropriate local clinical trials10
May lack awareness11 May lack access May face payment12 or
other logistical barriers May not meet eligibility
criteria May be fearful,
distrusting, or suspicious of research
May believe common myths 13
may have long-standing fear, apprehension, and skepticism about medical research because of past abuses
may hold values and beliefs different from those of Western medicine.
may face language and literacy differences can create additional barriers to effective communication
may have co-morbidities, which disproportionately impact their eligibility 14
*These groups comprise government-designated ethnic and racial groups, including American Indian/Alaska Natives; Asians; African-Americans; Hispanic/Latinos; and Native Hawaiian and other Pacific Islanders. They also include rural residents and people of low income and low literacy.
Awareness Barriers/
Promoters
Knowledge
Attitudes/Beliefs
Self-Efficacy
Organizational Environment
Health Literacy
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 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…
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#
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/concernSource: 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; andThanking participants for their contributions.
Nonverbal Active Listening Skills Maintaining open, receptive body language;Making eye contact with the speaker;Leaning forward; andNodding 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.
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 CommunitiesMore likely to receive either:
No treatment, orTreatment that does not meet current standards of
careDie from cancers that are preventableHave 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 cancerHelp doctors find ways to improve cancer careAre a quality cancer care option
© 2014 ENACCT, Inc. All Rights Reserved
Why Should We Care About Cancer Clinical Trials?
We all benefit from finding better ways to treat or prevent cancer
Rhonda Baer, NCI, 2005
© 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
Patients Are Always Treated for Their Cancer
No one gets a placebo (sugar pill) instead of appropriate treatment
Placebos may be used in prevention trials
© 2012 ENACCT, Inc. All Rights Reserved
We Have Protections Today Because of Abuses in the Past
20th 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
What Patients Should Think About Before Deciding to Join a Trial
© 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
Spreading the Word in Our Community
Family Friends Co-Workers Church Members Neighbors Community Leaders
© 2014 ENACCT, Inc. All Rights Reserved
There are Easy Ways to Find Available Trials in The Community
Cancer Information Service1-800-4-CANCERwww.cancer.gov
American Cancer Society1-800-ACS-2345www.cancer.org
© 2014 ENACCT, Inc. All Rights Reserved
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
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]
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