# Presentation: 089045

## NCI’s Clinical TrialsEducation Program

**Overview and History (2001-Present)**

## Clinical trials advance cancer care
However, only 3-5% of eligible adults participate
Many people: 
Are unaware of clinical trials
Harbor distrust about clinical trials
Are misinformed about the clinical trial process

- Clinical trials advance cancer care
- However, only 3-5% of eligible adults participate
- Many people:
- Are unaware of clinical trials
- Harbor distrust about clinical trials
- Are misinformed about the clinical trial process

**Why educate about clinical trials?**

**Notes:**
The Clinical Trials Education Program was established to increase awareness around clinical trials to patients, health professionals, and the public.  Clinical trials are necessary for future cancer prevention and treatment efforts. Currently, fewer than 5 percent of  eligible adults with cancer participate in clinical trials—far fewer than the number needed to answer the most pressing cancer questions quickly. 

There are several factors that contribute to low participation.  For example many people are unaware of clinical trials. It’s a foreign concept to them and they don’t consider them a viable treatment option. Some harbor distrust about clinical trials due to prior medical abuses, such as Tuskegee, and also, many don’t know how the clinical trials process works. We will cover these barriers in more depth in future webinars.

## CTEP: Goals 

- To increase...
- Awareness of clinical trials
- Knowledge of clinical trials
- Enrollment in clinical trials

**Notes:**
So the main goal of the Clinical Trials Education Program is to:
to increase awareness of, knowledge of, and ultimately enrollment in cancer clinical trials.

## CTEP: Long-term Objectives 

- Increase number of...
- Referrals to clinical trials
- Health care providers who participate in clinical trials
- Cancer patients and those at high risk for cancer-especially those in medically underserved populations- who enroll in clinical trials
- Leaders in cancer education and advocacy who perceive the CTES as an exemplar standard training tool.

**Notes:**
Long-term goals
To increase referrals to clinical trials
To increase the number of health care providers who participate in clinical trials
To increase the number of cancer patients and those at high risk for cancer-especially those in medically underserved populations- who enroll in clinical trials
To increase the number of leaders in cancer education and advocacy who perceive the CTES as an exemplar standard training tool.These are the goals that are stated in our logic model.

## Clinical Trials Education Series

**Clinical Trials Education Series**

- Over 20 resources
- Brochures, Workbooks, Web site, Slide shows, Videos, DVD, CD, and Booklets

- Created as a train-the-trainer program
- Targeted education and outreach to health professionals and the community

**Notes:**
To help health care providers, advocates and others interested in clinical trials to conduct clinical trials outreach, NCI has developed the Clinical Trials Education Series or CTES. CTES is a complete collection of 20 different educational resources ranging from booklets to videos. It was designed as a train-the-trainer program, which means that we would train CIS and CIS would in turn go out and train others and on and on to use these materials to increase awareness about clinical trials. The materials provide step-by-step instructions on how to conduct trainings, including diverse curricula and patient materials for those interested and tasked with creating organized and targeted education and outreach programs. CTES resources include a variety of formats for many audiences. As you can see, we have workbooks, booklets, brochures (both bilingual), videos, Powerpoint presentations (bilingual), and an online course for health professionals. Although this was designed as a train the trainer curriculum, CTES resources can also be used to directly educate patients and caregivers.

We will talk more about each of these components towards the end of the presentation.

## The Dissemination Model

**The Dissemination Model**

**Notes:**
FELICIA:
To increase the awareness and use of these materials, the Office of Education and Special Initiatives (OESI) at NCI took a partner-based approach to disseminating the Clinical Trials Education Series. This logic model demonstrates the process of how OESI and CIS worked with their Partners, providing them with support and technical assistance on how to use the materials.

If you could focus on the activities column, you will see the basic strategies that drove the dissemination including recruiting and maintaining partners; and maintenance was essentially responding to inquiries (either initiated by the partner or by us); promoting and disseminating the materials.  Since this was a new approach, we decided to conduct process evaluation to assess the extent to which the program was implemented as intended. That analysis was driven by our process measures.   So when we report evaluation results they link back primarily to these outputs as well as the short term outcomes related to PARTNER BEHAVIOR and Partner Satisfaction with CTES.

We did not and have not up to this point conducted outcome evaluation.  We are considering working with CIS to begin to do so; however, this is not currently in place, nor is it a priority for our office at this particular time.  But this may change in the near future.

## CTES Components

**Notes:**
Now we are going to go over the individual resources that are included in The clinical trials education series.

We would like to remind folks that CTES is designed for customization.  If your audience looks different from the pictures in the slideshows, you should switch those out.  If you need to mix and match slides or pages of a training or use only 5 minutes of a video then do that.  We expect that you are doing that. If not, you may not be using the CTES to its full potential.

## The Basic Workbook

**The Basic Workbook**

- For...
- Individuals wanting to develop a basic understanding of clinical trials
- Content...
- Clinical trial process
- How clinical trials lead to advances in care
- Participant protection
- Barriers to participation
- Finding clinical trials
- Exercises and reviews

**Notes:**
Cancer Clinical Trials:  The Basic Workbook – includes exercises and case studies that can help for training
The Basic Workbook is designed for health care professionals and others who want to  develop a basic understanding of clinical trials.  It is both a self-study guide and a resource for clinical trials education.  Its contents include:
The clinical trials process, which introduces the different types and phases of clinical trials, and defines key elements such as the protocol and randomization.
How clinical trials lead to advances in care looks at the full drug development process, of which clinical trials are a key part.  This includes the role of the FDA and the process for drug approval.  Importantly, it also includes specific examples of how cancer treatment and prevention have been advanced through clinical trials, and how the public can help facilitate the research process.
Participant protection in clinical trials introduces us to an especially important concept running throughout the series - the institutions, laws, processes and procedures which protect participants in clinical trials.  It includes the history of the development of patient protection, the role of the government in oversight, IRB’s, and the informed consent process.
Barriers to clinical trials participation, another key theme running throughout the series, discusses practical, cultural, financial, and other barriers to participation; and how they might be addressed.
Finding clinical trials includes identifying the sponsors of trials, the role of the NCI, how to refer people to clinical trials, and ways to locate clinical trials in one’s own community.

## The In-Depth Program

**The In-Depth Program**

- For...
- Health care professionals
- Others seeking a more in-depth understanding of clinical trials
- Content...
- Same as basic workbook and more— designing a trial and interpreting results
- Conducting, locating, and referring to trials
- Case study

**Notes:**
Cancer Clinical Trials: The In-Depth Program 
This resource expands on the Basic Workbook.  It features additional information on clinical trials design, resources for physician participation, and referral of individuals to studies.  The In-Depth program, as the title suggests, is designed for those who already have a basic understanding of clinical trials.  Some highlights include:
Definition of key members of the research team
Expansion on the design and format of clinical trials
Description of the statistical methods used to interpret the results of clinical trials
A more detailed discussion of the impact of clinical trials on cancer care, including additional examples  
A broader discussion of the historical context (medical abuses) which led to the laws and procedures in effect today 
Challenges for special populations and the need for diversity in clinical trials
A case study that illustrates some of the challenges and barriers to awareness and accrual to clinical trials, and how such challenges might be addressed.

## A Resource Guide for Outreach, Education, and Advocacy 

**A Resource Guide for Outreach, Education, and Advocacy**** **

- For...
- Individuals and organizations engaging their communities in clinical trials outreach and education activities
- Content...
- Educating yourself and others
- Reaching underserved      populations in your community outreach
- Working with the media
- Working with medical organizations

**Notes:**
Cancer Clinical Trials: A Resource Guide for Outreach, Education, and Advocacy 
This resource is an interactive workbook that provides direction and guidance to support your outreach and education activities.  Intended as a supplement to the previous “content” texts we discussed, the resource guide is designed to help individuals find ways to participate and to engage one’s community in clinical trials outreach and education. 

The slide lists the various sections found in the resource guide.  Each is designed to be self-contained and features practical tips and useful tools that can guide you in developing appropriate education and outreach efforts.  

This guide is not designed to be a comprehensive overview; rather it gives some examples of activities others have engaged in, and provides tools and suggestions for implementation in your community.

## Brochures (plain language)

***Online only***

**Brochures (plain language)**

- For...
- Cancer patients considering a clinical trial (English/Spanish)
- Medicare recipients considering  a clinical trial
- Content...
- What are clinical trials?
- What are my rights?
- What are the risk and benefits?
- What questions should I ask?
- What does Medicare pay for?

**Notes:**
Easy-to-Read Brochures (7th grade level)
These brochures are for:
Cancer patients considering a clinical trial (available in both English and Spanish)
Medicare recipients considering a clinical trial.
They respond to the questions listed on the slide in a way that is easy to read and understand.  They can be used as a part of the informed consent process and to assist patients considering treatment options.  

## Cancer Prevention Brochures

**Cancer Prevention Brochures**

- For...
- Healthy people who are at high risk for cancer
- Content...
- What are prevention clinical trials?
- What will I be asked to do?
- What are my rights?
- What questions should I ask?
*Available in English and Spanish*

**Notes:**
Cancer Prevention Brochures (7th grade level)
These brochures are for healthy people who are at high risk for cancer.  They provide information about cancer and clinical trials and help people decide whether or not participating in a prevention clinical trial is right for them.  They are available in English and in Spanish.

They can be used as part of the informed consent process, to assist people considering participation in a prevention trial, or to assist people considering risk reduction and prevention options.

## Providing Your Tissue for Research: What You Need To Know 

- For...
- Investigators
- Individuals who have been asked to provide tissue for research
- Content..
- A targeted list of questions and answers on how and why tissue specimens are collected and used in research

**Notes:**
Providing your tissue for research: what you need to know, discusses:
What is tissue
Why do people do research with tissue
How the tissue is collected
What happens after the tissue is collected
Finding out the results of the tissue used
Why we need information from your health records
How is your privacy protected
Risks involved
Changing your mind

## Booklets

***Online only***

**Booklets**

- For...
- Cancer patients considering a clinical trial
- Cancer patients considering a chemoprevention trial
- Content...
- What are clinical trials?
- What happens in a clinical trial?
- Should I take part?

***To be online only***

**Notes:**
Booklets
The booklets are longer than the brochures and provide additional information. They are all available online only. 
Taking Part in Clinical Trials:  What Cancer Patients Need to Know discusses what patients might expect if they participate in a trial, and presents issues to consider when deciding whether to participate.  It is available in English and Spanish.
Taking Part in Clinical Trials:  Cancer Prevention Studies:  What Participants Need to Know provides similar information about prevention trials.  It is also available in English and Spanish.

## Taking Part in Cancer Treatment Research Studies

- For...
- Individuals considering taking part in cancer treatment research studies
- Content...
- What are clinical trials
- Phases of clinical trials
- Randomization
- Protecting patients
- Risks and benefits of participating
- Important questions patients and caregivers should ask
- How to find clinical trials

**NEW!**

**Notes:**
This NEW book explains cancer treatment clinical trials and gives you some things to think about when deciding whether to take part. The book covers: what are clinical trials, phases of clinical trials, randomization, protecting patients, risks and benefits of participating, important questions patients and caregivers should ask, and how to find clinical trials

## Slide programs (English)

- Cancer Clinical Trials: The Way We Make Progress Against Cancer
- Cancer Clinical Trials: The Basics
- Cancer Clinical Trials: In-Depth Information

**Notes:**
Slide presentations for healthcare professionals and advocates making presentations in the community: all for a variety of audiences depending on literacy and languages
Cancer Clinical trials: The Way we Make Progress Against Cancer
Covers the basics about clinical trials
 to be used for health care professionals and advocates making presentations in a community setting or with limited literacy audiences
Cancer Clinical Trials: the Basics
Covers the previous, plus phases of clinical trials, randomizations, types of trials, protocols, barriers to participating
To be used to educate general population
Cancer Clinical Trials: In-Depth Information
Clinical trials in greater detail
For health care professional who have some background knowledge about medical research

## Slide programs (Spanish)

- Conversemos un rato...Información para combatir el cáncer en su comunidad
- La historia de José...Y cómo él ayudo a encontrar nuevas maneras de prevenir el cáncer
- La historia de Ana...Y cómo ella recibió tratamiento para el cáncer

**Notes:**
WE ARE GETTING AN ENGLISH SCRIPT.
Conversemos un rato...Información para combatir el cáncer en su comunidad
Covers basics about clinical trials
For healthcare professionals with knowledge in medical research, advocates making presentations to healthcare professionals
La historia de José...Y cómo él ayudo a encontrar nuevas maneras de prevenir el cáncer 
Fotonovela style that takes you on a journey of José, a man who is given the option of enrolling in a prevention clinical trial. 
Aimed at spanish speaking audiences in community
La historia de Ana...Y cómo ella recibió tratamiento para el cáncer 
Similar to José’s story, but talks about Ana’s journey. Ana is a woman who is given the option of enrolling in a treatment clinical trial. 

## Web course

**Web course**

- Incorporating Cancer Clinical Trials Into Your Practice

**Notes:**
This is our Incorporating Cancer Clinical Trials into your practice online training education course. It provides practical information and guidance to healthcare professionals  interested in referring patients to clinical trials, or conducting clinical trials, for the first time. I’m not sure how familiar you are about the course, but as it stands now, the course is divided up into two sections. The first section provides basic clinical trials information and could be used for a variety of people. The second section is for really for those health professionals who are interested in conducting clinical trials and how to go about doing that. Right now, users would have to complete the first section before they can move on to the second section. We recently did some interviews with users of this course and one of the things they told us was that the full course was very long, and because the first section was very basic, that it could be used for a wider audience. So, we are now working with our programmers here at NCI to try to separate the course into two and promote the basics course to a wider audience and the second particularly to health professionals. 

## Clinical Trials Education Series CD

**Clinical Trials Education Series CD**

**Notes:**
The Clinical Trials Education Series CD has a menu that allows viewers to look at and download each product: The CD contains:
Resources for health professionals and advocates: Workbook, etc
Slide programs for health professionals and advocates
Resources for use with patients or community groups
Slide programs for use with patients and community groups

## Trainer’s Guide

**Trainer’s Guide**

**Notes:**
This trainer’s guide is designed for both lay people and health professionals who are conducting group-training sessions with community and scientific audiences. It offers practical suggestions for taking your knowledge, tailoring it to the specific needs of your audience, and packaging the information in new ways. The guide provides ways to enliven your training, encourage more active participation, and enrich the learning experience for
everyone involved. The trainer’s guide also provides examples of icebreakers, energizers, and closing activities as well as checklists and charts to help you write objectives, develop a training plan, and conduct an evaluation.

The guide is divided into four sections:
I. Adult Learning Principles: 
II. Plan
III. Implement
IV. Summary and Conclusion

## Videos

- Cancer Trials... Because Lives Depend On It
- Cancer Clinical Trials: An Introduction for Patients and Their Families

**Notes:**
Cancer Trials... Because Lives Depend On It
Discusses prevention and treatment clinical trials to create general awareness about them
Cancer Clinical Trials: An Introduction for Patients and Their Families:
Video that discusses treatment clinical trials for patients and their families who may be considering participation. 

## DVD

**DVD**

- Newly updated DVD, Summer 2007
- Discusses treatment clinical trials for patients and families considering participation
- Updated version of the two videos combined
- Designed for education

**NEW!**

**Notes:**
(will be changed/deleted depending on progress of film)

## How-To Guide

- Using the Clinical Trials Education Series
- Describes the CTES resources
- Suggests various ways in which they might be used
- Provides detailed examples for using these materials intraining programs

**Notes:**
Using the Clinical Trials Education Series is a guide that:
Describes the CTES resources
Suggests various ways in which they might be used
Provides detailed examples for using these materials in training programs

## Questions?

**Questions?**

**Notes:**
Now we are going to open it  up for further questions.