Clinical Trials A Family Physician's Perspective Douglas G. Long, MD, FAAFP Primary care specialists diagnose and manage a wide variety 'Of problems. Cancer is one relatively small part of the practice of these clinicians. Patients with newly diagnosed cancer usually are referred to surgical specialists. Primary care physicians often determine future events after surgical care. Oncologists mayor may not be consulted depending on tumor type and past experiences of the physician, patient, and patient's family. Many primary care physicians think that chemotherapy regimens given empirically have little if any scientific evidence to support their use. Side effects of cancer treatment regimens often cause suffering and profoundly effect quality of life. There is a lack of communication between oncologists and primary care physicians. Dialogue between oncologists and primary care doctors may help solve communication problems. Clinical trials help determine which treatments are effective. Many clinical trials are conducted at the community hospital level. Most primary care physicians support clinical trials once they know about them. Education activities should be directed at promoting patient referral for participation in clinical trials. Cancer 67:1798-1799, 1991.
F
internal medicine, arid pediatrics are "horizontal" specialties. We cover a great deal of health concerns to varying depths. In family practice we feel we can manage 90% of what walks in the door. Everyday we deal with acute illnesses, such as otitis media in children, pneumonia, sprains, heart attacks, strokes etc. We also deal with chronic illnesses, such as hypertension, diabetes, chronic back pain, alcoholism, and arthritis. Many of us are active in obstetrics and deliver babies. Most of us are involved in periodic health care, which includes preventive medicine. We give immunizations, perform physical examinations, screen for certain conditions, and counsel patients on life-style modifications. Most of our cancer-related activity is in early detection and prevention. Other procedures include sigmoidoscopies, upper GI endoscopies, stool occult blood testing, Pap smears, mammograms, sputum cytologies, chest radiographs in selected patients, and removal of skin lesions. We counsel patients on diet avoidance of tobacco, smoking cessation, and exercise. Patients with cancer comprise a small portion of our practice. AMIL Y PRACTICE,
Presented at the American Cancer Society National Conference on Cancer and the hanging Healthcare System, San Francisco, alifornia, May 3-5. 1990. From Boothbay Harbor, Maine. Address for reprints: Douglas G. Long, MD. AAFP. P.O. Box 481, West Boothbay Harbor, M 04575. Accepted for publication September 14, 1990.
When we do sift out a patient with cancer, the usual first referral is to a surgeon of some sort in most cases. The primary care physician often performs the first biopsy, cytology, excision , or assists at surgery. Where the patient has his or her surgery determines the next events. If the patient has surgery at our local hospital, we usually get the patient back from the surgeon after the surgical treatment is concluded. Referrals are made to oncologists and radiation oncologists based on the tumor type and track record of a given therapy. Many of us have had the experience of seeing patients with hopeless situations made miserable for their last months by oncologists who felt they had to do somethingjust because they had a referral. Our county has the highest incidence of cancer in the state. Most families have relatives or neighbors who have had to travel 65 miles daily for radiation or chemotherapy. They see the side effect and have heard the horror stories. The commute is tough in the winter when the roads are hazardous during our Maine winters, or jammed with tourists in the summer. Patients who have their surgery at the tertiary care center disappear from sight for quite awhile. After their surgery, there is usually a tumor board pow-wow and the patient is sent for chemotherapy or radiation therapy. By that time, our names are long off the list as a r ferring doctor because the referring doctor has become the surgeon. Occasionally, we are called in at night to see a patient with a 105° temperature and a leukocyte count of 200.
No.6
FAMILY PHYSICIAN AND CLINICAL TRIALS
The covering oncologist may not know the patient or what medications the patient is taking. We deal with it. When radiation and chemotherapy have failed, we are suddenly reacquainted with our patient and participate with their terminal care by house calls, skilled care, or hospital admission. During the past year, the communication has improved. We are now getting copies of the oncology and radiation oncology office visits and their general strategy. We have a new hematologist who practices as an extension of the group in Portland; he is only 45 miles away. Clinical trials aren't promoted in Maine. It wasn't until last week that I discovered there was involvement in clinical trials. I saw a clipboard at a CME meeting co-sponsored by the American Cancer Society, which listed about ten clinical trials on various protocols. I was surprised to see not just Phase III trials, but also some Phase I and n. Clinical trials fit right in with what family physicians are all about. We have to retake our boards every 6 years to stay board-certified. We also have CME requirements to keep our certification status. We are among the most openminded of the specialties because we are' constantly learning. Primary care physicians also want to know that what they do has scientific merit. Most of our specialties are attempting to protect ourselves and our members with acceptable standards of care. These standards to be accepted as standards have to have certain levels of evidence to grant them standard status. This is mostly evidence demonstrated by double-blind studies or large cohort studies. When something we do is not justified by that type of evidence, we admit it and state them as "clinical options." Clinical trials are an acceptable way to get at the answers. Clinical trials should be promoted to the primary care specialties in each state. We should know what trials are ongoing and what the selection criteria are. Selling this concept to the patients would be offering them an opportunity to be on the cutting edge of care. We should be given information about side effects of agents used in the trials. Some primary care physicians may be enthusiastic enough to want to participate in the trials; most probably won't. They will refer their patients for the trials, however. Dialogue is the most important element in recruiting a widespread referral network for clinical trials. We need to get updates on our oncology referral patients. An occasional lecture or conference would do a great deal of good. Since oncologist Dr. Tom Keating came to Brunswick Maine, there has been a steady dialogue. The county society meetings offer a good forum for discussion prior to the dinner. He is also an A S volunteer and has presented lectures at the meetings. The eyeball to eyeball contact goes a long way toward e tablishing a trust rela-
Long
1799
tionship. If I have questions about how a patient is being managed, there is a body there to defend what is being done or change it. Family physicians and other primary care doctors need education in clinical trials. It doesn't have to be flogged to death. It just needs to be presented in a concise, effective manner. Cancer is a very small part of our practices. We learn in a different manner from subspecialists. A survey was commissioned by the ACS on how physicians learn. Subspecialists spent a great deal of more time reading journals than we do. We were accurately branded as being ruthlessly selective about our continuing education activities in selection of meetings and media. We do listen to audiocassettes and watch videotapes if the material is germane to our needs. We attend lectures and day conferences. The ACS has a new videotape on clinical trials, which is excellent. It only takes about 15 minutes to view the entire tape. The message is short but complete. There is information lacking on which clinical trials are available in local regions. I understand that Physicians Data Query (PDQ) has such references. Most family doctors have not even heard of PDQ. The program seems mostly oriented toward the oncologist. An increasing number of doctors are using their personal computers for literature searches through data bases such as Grateful Med or Paper Chase. There is a data base developed by the Massachusetts Division of the ACS called CANSEARCH. This is oriented toward primary care physicians and helpful. There is some consideration of adopting CANSEARCH nationally and expanding its scope to include questionable methods. This program does refer the user to PDQ for more specific information on specific treatments and clinical trials. Family doctors can access data bases wherever we live and practice. Primary care physicians are definitely interested in getting more information about questionable or unproven methods of treating cancer. A newsletter may work. Columns in medical periodicals would probably be overlooked. An accessible data base or toll free information number would probably be the most effective way to inform us of what is out there. In summary, the word on clinical trials needs to get out to the primary care physicians. Oncologists in genera] need to communicate more effectively with us if they are to expect our cooperation in referrals for clinical trials and treatment in cancers with poor track records for response to treatment. There needs to be a mechanism to help inform doctors about which clinical trials are available in their area and the selection criteria for those trials. There should be some easily acce ible means of obtaining information about questionable methods of treati ng cancers.
F
internal medicine, arid pediatrics are "horizontal" specialties. We cover a great deal of health concerns to varying depths. In family practice we feel we can manage 90% of what walks in the door. Everyday we deal with acute illnesses, such as otitis media in children, pneumonia, sprains, heart attacks, strokes etc. We also deal with chronic illnesses, such as hypertension, diabetes, chronic back pain, alcoholism, and arthritis. Many of us are active in obstetrics and deliver babies. Most of us are involved in periodic health care, which includes preventive medicine. We give immunizations, perform physical examinations, screen for certain conditions, and counsel patients on life-style modifications. Most of our cancer-related activity is in early detection and prevention. Other procedures include sigmoidoscopies, upper GI endoscopies, stool occult blood testing, Pap smears, mammograms, sputum cytologies, chest radiographs in selected patients, and removal of skin lesions. We counsel patients on diet avoidance of tobacco, smoking cessation, and exercise. Patients with cancer comprise a small portion of our practice. AMIL Y PRACTICE,
Presented at the American Cancer Society National Conference on Cancer and the hanging Healthcare System, San Francisco, alifornia, May 3-5. 1990. From Boothbay Harbor, Maine. Address for reprints: Douglas G. Long, MD. AAFP. P.O. Box 481, West Boothbay Harbor, M 04575. Accepted for publication September 14, 1990.
When we do sift out a patient with cancer, the usual first referral is to a surgeon of some sort in most cases. The primary care physician often performs the first biopsy, cytology, excision , or assists at surgery. Where the patient has his or her surgery determines the next events. If the patient has surgery at our local hospital, we usually get the patient back from the surgeon after the surgical treatment is concluded. Referrals are made to oncologists and radiation oncologists based on the tumor type and track record of a given therapy. Many of us have had the experience of seeing patients with hopeless situations made miserable for their last months by oncologists who felt they had to do somethingjust because they had a referral. Our county has the highest incidence of cancer in the state. Most families have relatives or neighbors who have had to travel 65 miles daily for radiation or chemotherapy. They see the side effect and have heard the horror stories. The commute is tough in the winter when the roads are hazardous during our Maine winters, or jammed with tourists in the summer. Patients who have their surgery at the tertiary care center disappear from sight for quite awhile. After their surgery, there is usually a tumor board pow-wow and the patient is sent for chemotherapy or radiation therapy. By that time, our names are long off the list as a r ferring doctor because the referring doctor has become the surgeon. Occasionally, we are called in at night to see a patient with a 105° temperature and a leukocyte count of 200.
No.6
FAMILY PHYSICIAN AND CLINICAL TRIALS
The covering oncologist may not know the patient or what medications the patient is taking. We deal with it. When radiation and chemotherapy have failed, we are suddenly reacquainted with our patient and participate with their terminal care by house calls, skilled care, or hospital admission. During the past year, the communication has improved. We are now getting copies of the oncology and radiation oncology office visits and their general strategy. We have a new hematologist who practices as an extension of the group in Portland; he is only 45 miles away. Clinical trials aren't promoted in Maine. It wasn't until last week that I discovered there was involvement in clinical trials. I saw a clipboard at a CME meeting co-sponsored by the American Cancer Society, which listed about ten clinical trials on various protocols. I was surprised to see not just Phase III trials, but also some Phase I and n. Clinical trials fit right in with what family physicians are all about. We have to retake our boards every 6 years to stay board-certified. We also have CME requirements to keep our certification status. We are among the most openminded of the specialties because we are' constantly learning. Primary care physicians also want to know that what they do has scientific merit. Most of our specialties are attempting to protect ourselves and our members with acceptable standards of care. These standards to be accepted as standards have to have certain levels of evidence to grant them standard status. This is mostly evidence demonstrated by double-blind studies or large cohort studies. When something we do is not justified by that type of evidence, we admit it and state them as "clinical options." Clinical trials are an acceptable way to get at the answers. Clinical trials should be promoted to the primary care specialties in each state. We should know what trials are ongoing and what the selection criteria are. Selling this concept to the patients would be offering them an opportunity to be on the cutting edge of care. We should be given information about side effects of agents used in the trials. Some primary care physicians may be enthusiastic enough to want to participate in the trials; most probably won't. They will refer their patients for the trials, however. Dialogue is the most important element in recruiting a widespread referral network for clinical trials. We need to get updates on our oncology referral patients. An occasional lecture or conference would do a great deal of good. Since oncologist Dr. Tom Keating came to Brunswick Maine, there has been a steady dialogue. The county society meetings offer a good forum for discussion prior to the dinner. He is also an A S volunteer and has presented lectures at the meetings. The eyeball to eyeball contact goes a long way toward e tablishing a trust rela-
Long
1799
tionship. If I have questions about how a patient is being managed, there is a body there to defend what is being done or change it. Family physicians and other primary care doctors need education in clinical trials. It doesn't have to be flogged to death. It just needs to be presented in a concise, effective manner. Cancer is a very small part of our practices. We learn in a different manner from subspecialists. A survey was commissioned by the ACS on how physicians learn. Subspecialists spent a great deal of more time reading journals than we do. We were accurately branded as being ruthlessly selective about our continuing education activities in selection of meetings and media. We do listen to audiocassettes and watch videotapes if the material is germane to our needs. We attend lectures and day conferences. The ACS has a new videotape on clinical trials, which is excellent. It only takes about 15 minutes to view the entire tape. The message is short but complete. There is information lacking on which clinical trials are available in local regions. I understand that Physicians Data Query (PDQ) has such references. Most family doctors have not even heard of PDQ. The program seems mostly oriented toward the oncologist. An increasing number of doctors are using their personal computers for literature searches through data bases such as Grateful Med or Paper Chase. There is a data base developed by the Massachusetts Division of the ACS called CANSEARCH. This is oriented toward primary care physicians and helpful. There is some consideration of adopting CANSEARCH nationally and expanding its scope to include questionable methods. This program does refer the user to PDQ for more specific information on specific treatments and clinical trials. Family doctors can access data bases wherever we live and practice. Primary care physicians are definitely interested in getting more information about questionable or unproven methods of treating cancer. A newsletter may work. Columns in medical periodicals would probably be overlooked. An accessible data base or toll free information number would probably be the most effective way to inform us of what is out there. In summary, the word on clinical trials needs to get out to the primary care physicians. Oncologists in genera] need to communicate more effectively with us if they are to expect our cooperation in referrals for clinical trials and treatment in cancers with poor track records for response to treatment. There needs to be a mechanism to help inform doctors about which clinical trials are available in their area and the selection criteria for those trials. There should be some easily acce ible means of obtaining information about questionable methods of treati ng cancers.
