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 11:00-11:10 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

ENACCT Peer to Peer Training

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?

I Can’t Believe It’s Not

JEOPARDY!JEOPARDY!

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


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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


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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?”


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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.


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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?


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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…


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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?

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.


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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


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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


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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


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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?


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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


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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

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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

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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

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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


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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%


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20% of all cancer patients;

3% of all cancer patients;

Who is eligible for CCT participation vs. who participates in CCTs?


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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.

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

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

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

BREAK1:15-1:45

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/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.


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.)


Teaching Strategies

Small-group work Case studies Brainstorming Lectures


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


Workshop Demonstration and

Debrief

Cancer Clinical TrialsA Quality Cancer Care Option

© 2014 ENACCT, Inc. All Rights Reserved

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


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


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


Why Should We Care About Cancer Clinical Trials?

We all benefit from finding better ways to treat or prevent cancer

Rhonda Baer, NCI, 2005


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


All Communities Should Take Part in Cancer Clinical

Trials


How Do Cancer Clinical Trials Work?


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


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


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


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


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…


What Patients Should Think About Before Deciding to Join a Trial


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


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


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


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


Spreading the Word in Our Community

Family Friends Co-Workers Church Members Neighbors Community Leaders


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


Thank you!


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#

Teachback Debrief &Implementation Guide

Walkthrough


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 Customization


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.

Documents

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