“Thank you for what you said.”

“Thanks for your comments.”

Words heard over and over in elevators, hallways, and coffee breaks in the last couple of weeks, as Colorectal Cancer Coalition research advocates spoke out during research-focused meetings … appreciation expressed for the reality-based voices of patients as research gets planned and evaluated.

We’ve been busy with three different meetings in the last ten days . . . and a big one coming up.

Colon and Rectal Cancer Clinical Trials Planning Meeting

Pam McAllister and I were in Washington meeting with two of the task forces that provide input to the National Cancer Institute Gastrointestinal Cancers Steering Committee.  Pam serves on the Colon Task Force, and I am part of the Rectal/Anal Task Force.

The GI Steering Committee approves new NCI clinical trial concepts and is key to getting trials prioritized and moving ahead.  Colorectal Cancer Coalition Board Chair Nancy Roach serves on that critical committee.

The task forces met to set clinical trials priorities and goals for the next eighteen months.  There was lots of new thinking and plans for the future.  Among ideas discussed in the Rectal Task Force were:

• The importance of clinical trials to find answers that were clinically meaningful to patients rather than just statistically significant.
• Helping patients to balance survival and side effects as they make decisions about their care.
• Reducing the impact of treatment on long-term side effects, including bowel function and peripheral neuropathy.
• Making sure that the right patient gets the right treatment — chemotherapy, radiation, and surgery.
• Including studies of genomic changes upfront in clinical trials.
• Involving advocates.

Comparative Effectiveness Research and Cancer Genomic Medicine

I was one the stakeholders discussing whether there was enough evidence to move ahead with three different genomic tests or if more research was necessary into their value.

My particular concern was screening all colorectal cancer patients’ tumors for Lynch syndrome in order to test and protect their relatives.

Unusual for many meetings I attend was the involvement of the people who pay for health care — the Centers for Medicare and Medicaid Services (CMS) and insurers including Humana and Blue Cross and Blue Shield.  Agencies that develop guidelines for testing and treating cancer patients were also there:  National Comprehensive Cancer Network (NCCN) and Evaluation of Genomic Applications in Practice and Prevention (EGAPP).

EGAPP has developed a recommendation for Genetic testing strategies in newly diagnosed individuals with colorectal cancer aimed at reducing morbidity and mortality from Lynch syndrome in relatives.

Despite fairly good evidence that testings tumors of newly diagnosed people with colorectal cancer for potential Lynch syndrome benefits both patients and their relatives, the group felt that processes were not in place to notify relatives when Lynch syndrome was found or counsel and test those relatives at risk.

Radiation Therapy Oncology Group (RTOG)

Pam McAllister and I were back together for the RTOG meeting in San Diego where we both are members of the Patient Advocacy Committee.

Emphasis during the meeting was on Patient-Reported Outcomes or PROs as a way of evaluating and reporting treatment side effects and quality of life.

While chemotherapy and radiation toxicity in clinical trials has normally been reported by doctors and nurses conducting the trials, research shows that there is a significant difference in what patients say about their own side effects and how toxicity gets reported.  PROs may be more meaningful and accurate, particularly in helping future patients make treatment decisions.

RTOG is one of the cancer cooperative groups, funded by NCI, to conduct clinical trials.

Stay tuned for reports from the 2011 Gastrointestinal Symposium beginning on Thursday, January 18 in San Francisco.

By Nancy Roach, the Founder of C3 and Chair of its Board of Directors

A National Cancer Institute (NCI) working group has developed recommendations about how to engage advocates effectively in NCI research activities.  The recommendations are open to public comment until November 30, 2009.  Rather than go into detail about the recommendations, I will explain from my personal experience why I feel they are important and present C3’s feedback.

The recommendations fill an existing vacuum

The first time I was invited to participate in a research meeting as a research advocate, I was excited, but uncertain about my role and responsibilities.  I knew I was attending a research meeting  and understood the basics of research.  But I didn’t understand how the research organizations were organized (what the heck was CTEP anyway?), how they functioned, or why I was invited to the meeting.

I left the three-hour meeting feeling like a failure.  I’d sat in the room listening to researchers talk about colorectal cancer research ideas and had no idea what I was supposed to do.  I didn’t understand the difference between concepts, protocols, and active trials and couldn’t decipher the acronym-speak.  When I was asked if I thought patients would be interested in a specific trial, I had no way to evaluate the question.

Over time, I learned that my experience was not unusual.  Some groups welcomed advocates as full partners in the clinical research process, and some advocates helped shape meaningful research.  Other groups welcomed advocates to meetings but not in the nitty-gritty of research development, and other advocates spoke rarely if at all.  In other words, our role was frequently unclear to everyone including ourselves.

The lack of clarity meant that developing training and support was hard – if we don’t know what we’re supposed to do, how can we learn how to do it?  And if researchers don’t know why we are in the room, why would they be interested in our feedback?  After all, most of the researchers have advanced degrees in their specialties.  We are there because we, or someone we love, got sick.  Why should our opinions matter?

Time for change

In 2007, NCI Director John Niederhuber asked the NCI Director Consumer Liaison Group (DCLG) for recommendations on how to best involve research advocates in NCI activities.  The DCLG constituted the Advocates in Research Working Group (ARWG) and charged them to work with NCI’s Office of Advocacy Relations (OAR) to develop recommendations.

The six high-level recommendations provide a framework for identifying, involving and supporting advocates, and address issues such as training, compensation and support.  They were presented to the DCLG in October 2009. This PowerPoint presentation reviews the process and participants behind the ARWG, and sets out the recommendations in some detail.

C3’s response

C3, through my participation, was honored to be involved with this effort from the start, along with other advocates, researchers, NCI staff and OAR.  I frequently reached out to C3’s research advocates to get their individual and collective feedback on the issues.  Given that C3 helped shape the recommendations, it’s not surprising that we are pleased with the outcome.  We believe the recommendations will ensure that when advocates participate in research activities:

• Advocates will understand how to fulfill their role effectively
• Other participants will understand the value of advocate participation
• Over time, the value of advocate participation will be evaluated and thereby improved

Aspects of the recommendations which we strongly support include:

• Development of a trained advocate cadre which allows advocates to cycle in and out of activities, and promotes engagement of new advocates
• Clear articulation of conflict-of-interest principles
• Training and orientation for advocates as to their role in researchTraining and orientation for researchers as to the role of the advocates in research

Having said that, no doubt there are areas where the recommendations will evolve once theory hits reality.  For example, some of the recommendations could hold advocates to a different standard than the other players at the research table.  Recommendation 2.1 (slide 26) states that NCI will develop inclusion and removal criteria for the advocate cadre.  The intent behind the recommendation is aimed at identifying the knowledge and skills that advocates need for successful engagement.  For example, if an advocate needs human subject protection training prior to engagement, that could be one of the criteria. At the same time, researchers aren’t subjected to this kind of explicit vetting by NCI prior to engagement.  Should they be?  If not, should advocates?  We are comfortable with the intent behind the recommendation, and will watch the reality of implementation with great interest.

We believe that at this point, forward motion is the best way to identify and resolve problems.

Forward motion is where the real challenges will occur.  Implementation will take time, resources and a culture change, because substantive involvement of advocates in research can be unusual.  Personally, I’m always surprised by that, because I view advocates as the customers of cancer research – and who develops a product without involving customers?  However, our involvement with clinical research is more complex to figure out than our involvement in the development of a new car or toothpaste, and these recommendations are a step in the right direction.

C3 urges NCI leadership to accept these recommendations and provide the resources and support necessary to implement them.  Dr. Niederhuber, the current NCI Director, has been committed to these efforts.  We hope that if and when a new Director is appointed, he or she shows the same level of commitment to our effective involvement with the system.