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Not surprisingly, patients with advanced cancer who have exhausted all proven therapies but arenít willing to ďgive upĒ often look to the pipeline of new drugs still being tested for some hope of extending their life. But because of Medicare regulations and insurance policiesí restrictions, by entering an early-stage trial, patients in terminal phases of cancer are effectively excluded from receiving the array of hospice services that they and their families need. If clinical trial patients and their families receive hospice care at all, it is often within just a few days of their death.
"Itís been an either-or choice," said Dr. Frederick J. Meyers, professor and chair of internal medicine at the University of California Davis Health System. "Patients with advanced cancer have been told they can be in a clinical trial or they can focus on quality of life. We donít think that is an acceptable choice. Why canít patients have both?"
Meyers and his colleagues sought to answer that question in their Simultaneous Care demonstration project at UC Davis School of Medicine. It compared a group of clinical trial participants receiving usual oncology care to a group receiving usual care plus palliative care services. Meyers is the principal investigator of the project, which challenged the notion that providing services focusing on pain control, symptom management, psychosocial issues and end-of-life planning might somehow disrupt participation in clinical trials. In fact, Meyers notes, if patients are in pain, they and their caregivers are less likely to focus on adhering to their therapeutic regime.
Simultaneous Care addressed important questions such as: How does concurrent palliative care affect the quality of life of patients in drug trials and their families? Does it affect their continued participation in studies? Are patients who are reaching out to experimental treatments in the hope of prolonging their life even interested in the services that hospice provides?
The study found that patients welcomed the palliative care intervention. Preliminary data also indicate that the quality of life of those receiving those services surpassed that of patients not provided concurrent palliative interventions. The patients receiving palliative care while in research trials adhered equally well to chemotherapy regimens, and they had a dramatically higher rate of subsequent hospice admissions compared to patients receiving usual care.
"The doctors not only embraced the intervention but they came to expect it. When the study stopped, they were all very disappointed."
- Dr. Frederick J. Meyers, UC Davis
Simultaneous Care enrolled patients participating in Phase I and Phase II clinical trials of investigational chemotherapy treatments. Phase I drug trials test the toxicity and maximum tolerated dose of compounds that have not previously been given to humans. They are not designed or intended to have therapeutic effects. Instead, by helping to identify safe doses of new medications, these trials offer patients an opportunity to make an altruistic contribution to improving care for future patients. Phase II trials measure the activity of a compound against the disease in humans for the first time.
All of the patients enrolled in Simultaneous Care had a prognosis of one year or less to live. One of the studyís hypotheses was that hospice-type palliative care and support services would increase the quality of life of patients enrolled in these studies and increase successful transition to hospice programs without adversely affecting the investigational trials.
A total of 44 patients were enrolled in the experimental group that received usual oncology care plus palliative services, and 20 patients were in a comparison group that received usual care only. The patients in the experimental arm became part of an interdisciplinary program that focused on symptom management, emotional support and discussion of end-of-life issues. Home visits were an important part of the program. Both the nurse case manager and medical social worker who visited patients in their home were experienced in palliative care. Each was trained to observe for toxicity of chemotherapy and to address questions within the scope of their particular discipline about pain, emotional issues and end-of-life issues, such as financial planning and wills.
Another key element of the project was that the Simultaneous Care nurse or social worker accompanied the patient to appointments with oncologists. If a patient forgot or was reluctant to tell the doctor about symptoms, such as pain or severe nausea, the nurse could remind or encourage her. If a caregiver was upset, he could talk to the social worker and be better able to assist the patient in making treatment decisions or following a therapeutic course. The nurse and social worker were available to support patients and their caregivers 24 hours a day, seven days a week.
Other members of the Simultaneous Care Team included a social worker who facilitated completion of follow-up surveys, the medical director, clinical research assistants and the Cancer Center research nurse. Throughout the project, the Simultaneous Care interdisciplinary team met weekly to discuss Simultaneous Care patients, including current physical and psychosocial assessments. The team was housed in the Cancer Center and routinely met with patients in the clinical area, making the team a regular, and soon trusted, part of the Cancer Center staff.
Meyers and his Simultaneous Care team spent three months planning for the project before enrolling patients. Institutional leadership was the key to their success, they say. Meyers and his colleagues reached out to cancer physicians and other staff in the hospital. The Simultaneous Care team met with each oncologist to discuss the project, emphasizing that palliative services could complement the care physicians and others were providing. Meyers said that their extensive outreach efforts were critical because this approach represented a fundamental change in the culture of the Cancer Center and project staff expected some resistance. As it turned out, project staff had few problems persuading clinical cancer staff of the utility of this approach.
"Symptom control and quality of life were valued as much as investigational
approaches to cancer therapy. We are doing a lot of patients in this country
a disservice by denying them the opportunity to receive hospice while they receive
investigational therapy, based solely on finances or regulatory concerns."
-Dr. Primo Lara, UC Davis
For the Simultaneous Care Team the study put to rest the idea that patients opting for clinical trials do not want to think about end-of-life issues. "One of the critical lessons learned is that you can raise issues of mortality within the clinical trials population," said John Linder, M.S.W., a social worker on the team. "In fact, if patients who want to focus on quality of life donít have to reject research trials, it might broaden the pool of potential research subjects quite a lot."
The UC Davis team also found that the addition of palliative services did not affect compliance with the experimental regime. Completion rates for chemotherapy were similar in the experimental and control groups. There was no statistical difference in the average number of cycles of chemotherapy completed.
Investigators also closely monitored the quality of life of trial participants. Patients in both groups completed a quality of life survey at the beginning of the seven-month trial and then at one-month intervals. Patients receiving palliative services showed an increase in the quality of life indicators as time went on, while patients in the control group showed a decrease, though these differences were not statistically significant.
As hypothesized, transition to hospice also increased for the experimental group. Fifty-three percent of the usual care group was referred to hospice compared to 92% of the Simultaneous Care patients. Median length of stay in hospice for the Simultaneous Care patients was 54.5 days compared to 37 days for patients receiving usual care. The study suggests that clinical trial patients would likely choose hospice services during far-advanced stages of illness if health care professionals supported and introduced the palliative care to them.
Dr. Primo Lara, who cares for patients on clinical trials at UC Davis, said the study provides evidence that bringing palliation and anti-cancer treatment together works. "This project showed us that this was feasible, it was doable, it was effective and it enhanced the outcome measures that we had identified, such as quality of life," Lara said. "It may change the standard of care. I am one of the converted. It has rubbed off on all of us. We all got on the bandwagon."
"One of the big paradoxes in our society is that investigational drugs are considered incompatible with palliative care and hospice intervention and that patients on clinical trials cannot simultaneously be given hospice care," Lara adds. "This is what Simultaneous Care was providing to us. Symptom control and quality of life were valued as much as investigational approaches to cancer therapy. We are doing a lot of patients in this country a disservice by denying them the opportunity to receive hospice while they receive investigational therapy, based solely on finances or regulatory concerns."
Meyers sees the significance of their findings not only for patients but also for the physicians and institution. "The bottom line lesson is that we confirmed our hypothesis that you can do palliative care and investigational therapy at the same time," Meyers said. "We changed the culture of the Cancer Center. The doctors not only embraced the intervention but they came to expect it. When the study stopped, they were all very disappointed."
The comprehensive services provided as part of Simultaneous Care required an investment on the part of the medical center. For each patient, the nurse visited two to four times a week and the social worker once or twice a week. Because the Promoting Excellence grant did not fund clinical activities, the Department of Internal Medicine had to cover the costs of these positions, which were approximately $150,000.
But the hopeful lessons from Simultaneous Care have been well invested in the future. Meyers and his colleagues received a $2.5 million, five-year grant from the National Cancer Institute to extend their work using a patient and family educational intervention with a randomized trial in three sites: UC Davis, The City of Hope Medical Center in Los Angeles and Johns Hopkins Medical Center in Baltimore.
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