The Institute of Medicine’s definition of a good death is “one that is free from avoidable distress and suffering for patients, families, and caregivers; in general accord with the patients’ and families’ wishes; and reasonably consistent with clinical, cultural, and ethical standards.”
Palliative care advocates a holistic psycho-social-spiritual approach to caring for people at end of life. Phase 1 study trial volunteers have often been excluded from the palliative care that is considered standard for people who are at end of life. However, there is a growing call for providing Phase 1 volunteers with compassionate care in several domains.
The following is an excerpt from the Journal of Palliative Medicine Volume 5, Number 5, 2002:
The vast majority of terminally ill patients will suffer from physical symptoms. An essential component of their care involves minimizing the physical symptoms of pain, fatigue, drowsiness, insomnia, dyspnea, and anorexia, which are common at the end of life.
The impact of participation in clinical trials on physical symptoms can paradoxically exacerbate the discomfort the patient is already experiencing by introducing distressing and even life-threatening side effects from the experimental therapy.
In addition volunteers undergoing experimental therapy frequently have to submit to testing and monitoring that can include regular needle sticks for blood draws, biopsies, and long-term indwelling venous catheter as part of the protocol.
PSYCHOLOGICAL AND COGNITIVE SYMPTOMS
The psychological and cognitive symptoms of a dying patient may include depression, sadness, anxiety, or irritability. This can be exacerbated in a clinical trial situation as the volunteer may be experiencing adverse reactions to the drugs and lack the compassionate, emotional support that palliative/hospice care provides.
SOCIAL RELATIONSHIPS AND SUPPORT
Having social supports such as people to talk to, to help reflect on one’s life, or simply to have fun is an important part of making the process of dying less burdensome and more meaningful.
If a patient must be in a rented room far from home, then participation in a trial may remove him from his family, friends, and community at a crucial time near the end of life and hence diminish essential sources of support.
ECONOMIC DEMANDS AND CAREGIVING NEEDS
The economic demands and caregiving needs of terminally ill patients can be overwhelming. Lack of insurance and loss of income along with substantial nursing and personal needs in patients with terminal illness may impose significant economic demands and caregiving burdens on patients and those who take care of them.
Participating in a research trial may increase some of the economic burden because, although the experimental drug is usually paid for there is usually more intensive monitoring and testing which can increase the costs of travel, room, and board. Additionally, patients with terminal illnesses need family members to accompany them, thus increasing the economic burden
SPIRITUAL AND EXISTENTIAL BELIEFS
Attending to spiritual and existential concerns can be an important part of the experience of a patient with a terminal illness regardless of whether or not the patient participates in a clinical trial.
SUGGESTIONS FOR SOLUTIONS
Given the need to involve terminally ill patients in clinical research, we suggest the following strategies be used to assist in providing ideal end-of-life care for participants in clinical trials.
1. Modify the informed consent discussion.
Efforts to improve consent forms have not entirely succeeded in improving subject understanding of research protocols. Patients with untreatable malignancies are expected to have a realistic understanding of the likely outcome of their participation in a trial even in the face of their hopes for some gain, be it a sense of purpose, of struggling or carrying on in the face of death, or of altruism. In this light it is important to find strategies for honestly conveying the improbability of therapeutic benefit in the course of participation while supporting patients’ sense of meaning, purpose, and hope in the course of their enrollment.
Explicitly discussing the end of life in as supportive a fashion as possible during the consent process might help avoid the misconception about the benefits they are likely to derive from the trial.
2. Build a palliative care component into clinical trials.
Research subjects with terminal illnesses should not have to forgo the standard of care in palliative medicine in the course of enrolling in research.
Phase 1 clinical trials are not intended to deal with emotional or existential difficulties at the end of life.
Incorporating palliative care specialists into Phase 1 cancer trials would afford the resources and inclination to address the needs of dying patients. Funding for a Phase 1 trial should include resources for providing palliative care in the study protocol.
3. Attend to the needs of family caregivers of terminally ill research subjects.
When research subjects are terminally ill, the needs of their family members, which are so substantial under these circumstances, warrant more attention. It would be useful to adopt the model of palliative care in which the patient and family are considered one unit that requires support for psychological and physical needs, and help in anticipation of loss and grief.
4. Arrange for continuity of care so that dropping out of a trial does not jeopardize medical care.
For those participants who enroll in trials in which their health care provider is not the investigator, the tendency may develop to identify the clinical investigator as their care provider. It is important that the affiliation with the original clinician not be lost and that there be good communication between investigators and clinicians so that if and when it is necessary or desirable for participants to withdraw from research, they perceive that they have options for medical management and do not feel a sense of abandonment.
5. Train clinical investigators in end-of-life care.
As knowledge about the dying process grows, end-of-life care becomes an increasingly complex skill. Just as clinical investigators should receive training in conducting good research, they need training in end-of-life care. Caring for dying patients requires skills in communication, symptom management, coordination of care, and preparation of the family for what to expect. While these are a different set of skills than those considered necessary to be a good researcher, studies that include patients with life-threatening illnesses, require that the investigator be skilled in addressing the needs of this patient population.
6. Develop a counseling strategy for terminally-ill participants in clinical research.
Regardless of what expectations and rationale each participant has, subjects might benefit from counseling that recognizes the unusual circumstances they face as they choose to participate in research near the time of death. Without such assistance, they are more likely than most patients to die without ever having come to terms with the end of their lives. Such counseling would take into account the fact that these individuals have chosen a path that differs from the usual hospice care: their need for caring and comfort is as great as it is for any other individual during sickness and dying. (Agrawal, Manish, M.D.l, and Marion Danis, M.D., "End of Life Care for Terminally Ill Participants in Clinical Research," JOURNAL OF PALLIATIVE MEDICINE, Volume 5 Number 5 2002.