|
Pam McAllister, Ph.D., & Mary Lou Smith, Co-Chairs
Thursday, January 17, 2008
We discussed reviews of concepts and protocols by the advocates and all agreed to be more observant and to review all materials sent to them for review.
The Patient Advocacy Committee section of the RTOG Grant Renewal was discussed and changes were made to the presentation to be given during the Sunday meeting.
Saturday, January 19, 2008
The committee discussed problems in tissue acquisition with Dr. Elizabeth Hammond. Possible ways advocates might be helpful in increasing tissue submission were discussed.
|
 |
Pamela McAllister, Ph.D.
Mary Lou Smith, Co-Chairs
- We discussed the review of concepts and protocols done over the past 6 months.
- We met with Dr. Hammond and later with Dr. Dicker to discuss problems in collecting tissues from patients who are participating in clinical trials and possible directions we can take to assist in this effort.
- We discussed plans for revisions of the Patient Advocate portion of the grant renewal.
- We briefly discussed plans for our session at the next meeting including especially our need for additional advocates to cover the committees beyond the disease site committees and our need for an advocate to cover the Sarcoma Committee.
|
|
Pamela McAllister, Ph.D.
Mary Lou Smith, Co-Chairs
Wilma Hoffman gave a presentation on protocol development in RTOG followed by questions and answers.
Sharon Hartson-Stein gave a presentation on the results of the survey of advocacy groups we have been working on over the past year. The response to the survey by advocacy groups has now exceeded 50% and has given us information which will help RTOG provide information to advocacy groups in a form they will find most useful for distribution to their membership. We discussed the possibility of working with Sharon to develop a paper about the survey results for the RTOG newsletter.
Mary Lou Smith gave a presentation on treatment side effects and how they impact quality of life both long and short term. The presentation, further, indicated differences in perception between patients and medical professionals.
The Patient Advocacy Committee strategic plan was provided to all of the committee members and was discussed with all members of the committee who are in agreement with the goals for 2007 as they were presented.
We discussed protocol evaluation and decided we would all use the ACRIN project impact form when we evaluate protocols. We may later develop our own form but the current project impact form seems to fit our needs at this time.
|
|
Pam McAllister, Co-Chair
The Patient Advocacy Committee met on June 23rd and 24th where we initially discussed the transfer of the chairmanship from Hank Porterfield to co-chairs: Mary Lou Smith and Pamela McAllister. Since Hank had originally accepted the chair position for a period of only two years to see the committee through a period of transition, he has stepped down. We thank Hank for his valuable service over the past two years during which the committee was reconstituted and now includes 7 members all of whom are very experienced in advocacy groups representing a variety of cancer disease sites.
The committee now consists of:
Mary Lou Smith, The Research Advocacy Network, Breast Cancer, Pamela McAllister, Colorectal Cancer Coalition, GI Cancers, Thomas Simon, Caring Ambassadors, Lung Cancer, Nancy Leopold, Support for People with Oral and Head and Neck Cancer, Inc., Head and Neck Cancers, Cynthia Rixey-Scott, Brain Tumor Action Network, Brain Cancers, Kate Murphy, Colorectal Cancer Coalition, Gynecological Cancers Hank Porterfield, Us, Too!, Prostate Cancer.
We discussed a "job description" of an advocate within RTOG and began developing a description we will finalize before the next meeting.
During most of the open session, we discussed the role of advocates within their advocacy organizations. In the closed meeting, we discussed the continuing projects begun at prior meetings. The committee generated a list of about 40 advocacy organizations representing cancer disease sites of interest to RTOG. The list of advocacy organizations is complete but requires periodic updates since the contact person changes, sometimes frequently. The advocacy Committee will maintain the list to assure information in it is current. A survey to be completed by the organizations, intended to ascertain their need for information about RTOG and its trials was developed. The survey was sent by Sharon Hartson-Stine to the list of organizations which had been developed.
Several organizations have responded to the initial request to complete the survey. Those had not responded will be contacted by members of the advocacy committee to update contact information and to urge them to complete the survey so that we can have a greater understanding of their need for information about RTOG including information about completed trials and current trials may be of interest to their constituency. We hope prior to the next meeting all of the groups will have been contacted so material of benefit to them can be sent as it is developed.
We discussed the desire of the advocates to review concepts and protocols in their disease area so we can provide advocacy input we hope will be of value in the development of the trials.
We discussed the need to develop materials for a patient advocacy page on the RTOG website. When an advocacy page on the website becomes available the committee plans to develop materials suitable for use by advocates, their organizations and the general public.
Several of the members of this committee are also working with the Recruitment Working Group to assist in increasing accrual to existing trials.
|
|
Hank Porterfield, Chair
In our first session the committee met with Sharon Hartson for a discussion of various Public Relations activities. The committee will assist whenever asked and will also promote activities of RTOG to advocacy organizations. Sharon asked us to review the newsletter material before publishing and we readily agreed.
ENCOURAGING ENROLLMENT IN CLINICAL TRIALS
Generally accrual is assisted by the publishing of a modest brochure discussing the trial and answering questions. Committee members are eager to assist in this program and recommend trials wherever possible be accompanied by a brochure.
CANCER RESEARCH: A GUIDE TO CLINICAL TRIALS
Module 6 of this program offers a complete description of tissue and an explanation of the importance of tissue collection.
Committee members unanimously agree on the importance of tissue collection
This training program is an essential part of advocate's information accrual and the advocacy committee continues to train on the clinical trial series. We realize techniques, medications, procedures and research all offer opportunities for improvement therefore it is important to keep up with change.
PRESENTATION BY DR. ELIZABETH HAMMOND - Manager of Tissue Bank for RTOG
In our second session we invited Dr. Hammond to present to us how tissue collection works. In our previous session we had generated a list of questions which Dr. Hammond was able to answer fully and completely.
This session with Dr. Hammond stimulated so much interest and enthusiasm we have invited Dr. Hammond back to present at the next semi-annual meeting. We look forward to receiving the benefit of her expertise and experience as she presents to us. We thank Dr. Hammond for her generosity in giving us the full background and nature of tissue collection.
|
|
Pam McAllister, Ph.D. for
Hank Porterfield, Chair
The Patient Advocacy Committee met with Sharon Hartson-Stine to discuss the work we had done since the prior meeting. We also discussed the possibility of the fact the RTOG website may be changed to limit some material to members only. If the site is changed to limit parts to members only and part to be open to the public, it is important to include material that is of interest to the general public, mostly patients and caregivers, on the public side of the website. We discussed what we feel may be important to the public and agreed to continue to communicate with Sharon when the website is being revised so we can provide input on what is appropriate and important to the public.
We also asked Sharon who we might be contacted to be included in the individuals to receive protocols for evaluation. Sharon already notified those concerned so we should all receive protocols as appropriate. Since Cynthia is new and this was the first meeting she has attended, we then spent time discussing what is expected of a patient advocate and how she might learn more so she will have a greater understanding of the system.
We adjourned early so we could attend the Recruitment Working Group meeting. We continued our discussions of the same matters in our closed session.
|
|
Hank Porterfield, Chair
The Patient Advocacy Committee conducted a survey of literature available for patients and medical personnel explaining clinical trials to patients. This will assist us in developing materials to promote RTOG clinical trials.
After meeting with the Group Chairman the committee invited Sharon Hartson to attend our meeting as a means of discussing ways to advertise RTOG Clinical Trials and improve enrollment. Sharon was in agreement with the writing up a promotion piece on specific trials and submitting the same to the committee prior to making the material or brochure available to constituents. The committee will peruse the suggested material and offer constructive thoughts prior to publication.
In addition, the committee is submitting to Sharon a list of advocate organizations and leaders to whom materials may be sent for distribution to their constituents. The Patient Advocacy Committee believes this procedure will indeed assist in accruing patients for RTOG clinical trials and assist doctors and nurses in presenting a full picture of the individual trials.
|
|
Hank Porterfield, Chair
Training commenced on Module VI of the NCCG Training Series: A Cancer Research Guide to Clinical Trials.
Module VI deals with tissue and its use. It is a very well written synopsis of the planning and establishment of tissue banks.
The group studied the definition of bodily tissue, fluid or other substances. Specimens include at least 24 different types of human blood, hair, tumor, etc. A key performer in the study of tissue is a pathologist. In order to provide him with workable samples it is necessary to store tissue effectively, such as formalin fixed, paraffin, embedded or fresh frozen, snap frozen, etc.
Some cooperative groups have established a central tissue bank with others rely on a virtual tissue bank (tissue housed in different places but catalogued and available when needed). Use of tissue banks can become very important down the road as new agents are developed and better understanding is acquired for how cancer reacts with specific tissues in various sites.
The Patient Advocacy Committee will continue to study the important uses of tissue in future meetings to get a clear understanding of how we can provide better patient acceptance of tissue storage and its contribution to future scientific endeavors.
|
|
Hank Porterfield, Chair
The RTOG Patient Advocate Committee convened at 2:00p.m. This is a special session devoted to a continuation of the study of the training units produced by CNCCG for advocates to be better advised on the many issues affecting the RTOG and the various Clinical Trial Groups. The session was devoted to Module 4 titled:
CANCER RESEARCH: A GUIDE TO CLINICAL TRIALS – SURGICAL & RADIATION THERAPIES.
This module obviously has great interest for RTOG advocates because of the two major forms of treatment i.e. Radiation & Surgery and their application to the many types of cancers. The program analysis began with a description of cancer tumors and their stages then moved into various forms of surgical therapies. Secondarily, radiation therapy was completely described starting with how it was developed and going through the various stages of modernization.
We then studied the role of pathology and clinical laboratories in imaging slides and how proper analysis and diagnosis affects outcomes.
Combined therapies using surgery and radiation were also a part of the modalities studies.
Lastly the role of the FDA was described and studied including how new devices are approved by FDA as well as new drugs and treatments.
OPEN SESSION: 5:00 PM
In order to follow up on this training an open session was held at 5:00 o’clock- Chairman Hank Porterfield introduced Dr. Mack Roach, Professor of Urology & Oncology at UCSF, who presented a very thorough program on the various developments that have contributed to the modernization of radiation therapy. Dr. Roach’s presentation was very well accepted and was followed by a lively question and answer period. We thank Dr. Roach for his unique approach to presenting radiation therapy.
|
|
Hank Porterfield, Chair
The Coalition of National Cancer Cooperative Groups has researched and published a series of guides designed to train Patient Advocates on all phases of cancer clinical trial development and related administrative procedures.
Our first training session last year covered Module I, an in-depth explanation of the eleven cooperative group members and supporters of the Coalition, as well as, SWOG the 12th group, which is not as of yet a member.
We trained in January 2003 on Module II, a complete analysis of the genesis of clinical trials and how protocols are developed and carried through completion.
In this June 2003 meeting, we concentrated on Module III, which is a complete study of the development of drugs. Explained how they are brought to trial, approved or disapproved by the FDA and finally reaching market and patients.
This training is critical for efficient contribution of Patient Advocates to RTOG committees and will be reviewed, updated and repeated as the committee grows to become an efficient contributory factor in RTOG procedures.
|
|
Hank Porterfield, Chair
This period was devoted to a training session on Module II of the coalition program titled CANCER RESEARCH: A GUIDE TO CLINICAL TRIALS. The subject of Module II is Cancer Clinical Trials. The coalition has published a beautifully designed modules numbered 1 - 6 complete with all the issues surrounding clinical trials complete with thought provoking questions at the end of each chapter. The training was led by the Chairman with good input from Dr. McAllister, a committee member and one of the contributors to one of the modules. With excellent participation including several guests of the committee from the CRA group, a stimulating session resulted.
After adjourning the training session the committee reassembled to enjoy a really very complete PowerPoint presentation by Dr. Howard Sandler, Chair of the Genitourinary Cancer Committee. Dr. Sandler reviewed standard practices in Radiation Therapy and then offered a stimulating discussion on new systems and procedures in Radiation Therapy. A number of guests attended the session in addition to members of the Patient Advocacy Committee.
The second session which took place on Saturday, January 25, 2003 was a closed meeting which was devoted to establishing procedures for elevating the quality of participation and contribution of patient advocates particularly in site committee assignments. To accomplish this we will continue training sessions on how patient advocates can best represent their constituencies through a thorough understanding of the remaining modules in the THE GUIDE TO CLINICAL TRIALS SERIES.
In addition each patient advocate will report back to the committee in this closed session. On such items as progress made, any obstacles to contribution observed, ability to provide patient insight into design of clinical trials and general observations on how to improve his/her contributions to their committee.
|
|
Hank Porterfield, Chair
The Patient Advocacy Committee met at 2:00 on Thursday, June 13, 2002 to review module I of the Self Study Guide for Patient Advocates produced by the National Cancer Cooperative Groups, Inc. (The Coalition). Titled “Cancer Research: A Guide to Clinical Trials”, this first module requires concentration and is a marvelous tool for patient advocates.
The training session started with the identification of various cooperative groups all of which belong to the Coalition and the Southwest Oncology Group, which was included in the discussion.
As part of the educational process a detailed discussion took place on the 4 NCI programs, which are presently considered to be in trial status. These are the CEP (Concept Evaluation Panel), the CTSU (Cancer Trial Support Unit), the CIRB (Central Internal Review Board) and the SOTS (State of the Science) groups. In addition the OHRP (Office of Human Research Protection) was carefully noted.
Other concentration areas were 1. types of Co-op groups, 2. Co-op group Structure, 3. Disease Committees, 4. Modality Committees, 5. Behavioral specialties and Working groups.
Following this training session and a break our main speaker was Dr. Howard Sandler, Chairman of the Genitourinary Cancer Committee. Dr. Sandler presented a very nice analysis of how committee chairs work, expectations of cooperation and input from patient advocate representatives and important contributions that PA’s can make. Following this, a Question & Answer session answered numerous questions and brought out useful suggestions, many concentrating on contributions that advocates and advocate groups can make to the clinical trial process.
|
|
Elizabeth Layne, D.D.S., Chair
Gail Segal, Co-Chair
The meeting began with a short discussion of the Patient Advocacy Training Program for patient advocate members of cancer cooperative groups such as RTOG. This program is in the process of development by the Coalition of National Cancer Cooperative Groups. The steering committee members of the Patient Advocacy Committee piloted one of the training modules during this RTOG meeting. The Patient Advocacy Committee steering committee members have been invited to attend the first full training session to be held in April, 2002.
Jackie Fisher, RN, BSN, OCN, gave a well-received presentation entitled “Assessing Quality of Life”. Quality of Life studies in RTOG began in 1990. Health related Quality of Life “refers to the extent to which one’s usual or expected physical, emotional and social well-being are affected by a medical condition or its treatment.” Basic tools used to evaluate Quality of Life were discussed. It was mentioned that barriers to Quality of Life assessment in all clinical trials include a lack of extra money for performing the assessments as well as the time it takes to obtain all the data needed.
It was announced that the Coalition of National Cancer Cooperative Groups has grants of up to $10,000 for Patient Advocacy Committees of Cooperative Groups to do pilot projects. Ideas were solicited.
A short presentation was given by Lisa Chin, JD, MPH about a planned clinical trial investigation regarding “ A Needs Assessment Evaluation of Participants and their Families in RTOG Studies”. This would involve several surveys including a Supportive Care Needs Survey and a modified version of the Critical Care Family Needs Inventory.
|
|
Elizabeth Layne, DDS, Chair
Gail Segal, Co-Chair
The meeting featured two presentations. Corey J. Langer, MD, Medical Oncologist from Fox Chase Cancer Center spoke about Novel Biologic Agents. Dr. Langer explained that the new biologic agents would likely necessitate some changes in the way clinical trial protocols were developed. These biologics are likely cytostatic but have potential synergy with cytotoxic drugs. The clinical trial emphasis may need to shift to safety and chronicity more than the maximum tolerated dose and primary trial endpoints might need to be overall response rather than survival. Phase III trials may develop directly from phase I trials.
Two speakers from the Coalition of National Cancer Cooperative Groups discussed their organization. Nancy Connelly, Director of Communication, gave a brief overview of the Coalition, its goal of increasing participation in cancer clinical trials and their initiatives to date. The Coalition has co-sponsored four annual Summit on Clinical Trials meetings, the Harris Poll on Public Attitudes to Clinical Trials and is producing a national awareness campaign regarding clinical trials which included an 8 page supplement in the June, 2001 Newsweek which reached 21 million readers.
Mary Lou Smith, Director of Patient, Payer and Government Relations, spoke about the Patient Advocate program within the Coalition. Each Cancer Clinical Cooperative Group has a representative, usually the committee chair, on the Coalitions Patient Advocacy Board. Betty Layne is the representative from RTOG.
An Advocate Training Manual is under development. A sample of one of the modules was distributed. It is planned to provide this training to interested persons at the next RTOG meeting in February 2002.
Trial Check, an online database of clinical trials is being developed for the Coalition’s website. It will provide information about clinical trials conducted by its member organizations and will be available this fall by password only to providers and advocacy groups. A version for patients will be developed in the future. Some of the advocates were able to test the website and provide input into making the site easier to navigate.
Several organizations represented on the RTOG Patient Advocacy Committee exhibited their materials during the meeting.
|
|
Elizabeth Layne, DDS, Chair
Gail Segal, Co-Chair
The meeting began with Betty Layne presenting highlights of the Thursday evening educational presentation of the NCI’s Cancer Clinical Trials Education Program (CCTEP) sponsored by this committee. This program is a train-the-trainer program that provides health professionals, patient advocates, and community educators with the knowledge and tools to educate and inform patients, their families and the community about clinical trials. This program prepares participants to:
- Understand what clinical trials are, how they work, and what participation involves
- Identify the barriers that make participation difficult for patients and the public
- Communicate effectively with cancer patients and their families about the importance of clinical trials and participation in clinical trials
- Identify and use educational resources appropriately.
This committee wishes to thank Novartis Pharmaceuticals for their generous support of this presentation. Approximately 50 people attended this workshop. 3.0 Continuing Education credits were available for attendees from (SOCRA) the Society of Clinical Research Associates.
Gail Segal reported from the Cancer Clinical Trials Education Program that there are five general steps that patients progress through during the clinical trials process:
- Discussion of treatment options with healthcare team members
- Predecision phase, during which time the informed consent is used as an educational/introductory tool
- Informed consent
- The trial itself
Post trial
Discussion of informed consent in general and the NCI template as used by RTOG specifically ensued. Several suggestions were introduced to improve the informed consent as used by RTOG. These included:
- Attachments to the informed consent which can provide needed explanations for the patient on many of the terms used especially in the areas of procedures, side effects, and risks. These attachments would keep the informed consent itself from becoming too long.
- Information should be geared to a relatively low educational level, e.g., the 8th grade. Sentences should be simple, contain no more than 9 words and be culturally sensitive. The problem of how to develop an informed consent for those who are illiterate or understand a foreign language was not solved. Informed consents in Spanish are available on a case by case basis through several institutions for a price.
- It was decided that the general committee meetings at the RTOG semi-annual meetings would be devoted to education to inform patients and advocates that attend these meetings about different aspects of treatment modalities and new research such as conformal radiotherapy, vaccines and tumor markers, angiogenesis, MMPI’s, growth factors, and Quality of Life tools.
- There was a discussion of the possibility of an online forum for this and other topics, possibly through the RTOG website. Suggestions for an education forum for the next meetings included different aspects of treatment modalities and new research such as conformal radiotherapy, vaccines and tumor markers, angiogenesis, MMPI’s, growth factors and Quality of Life tools.
|
|
|
|
