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A Staff Dialogue on Phase I Trials: Psychosocial Issues Faced by Patients, Their Families, and Caregivers

Hematology-Oncology Department, Massachusetts General Hospital, Boston, Massachusetts, USA

Correspondence: Bruce A. Chabner M.D., Massachusetts General Hospital Cancer Center, Cox Building, Room 640, 100 Blossom Street, Boston, Massachusetts 02114-2617, USA. Telephone: 617-724-3200; Fax: 617-724-3166; e-mail: chabner.bruce{at}mgh.harvard.edu

Shortly before his death in 1995, Kenneth B. Schwartz, a cancer patient at Massachusetts General Hospital, founded The Kenneth B. Schwartz Center to be housed at Massachusetts General Hospital (MGH). He created this center to advance the hopes, goals, and ideas expressed in his article, "A Patient's Story," published in the July 16, 1995 issue of the Boston Globe Magazine. The Schwartz Center is a non-profit organization dedicated to strengthening the relationship between patients and caregivers and to supporting and advancing "compassionate health care delivery in which caregivers, patients and their families relate meaningfully to one another in a way that provides hope to the patient, support to caregivers and sustenance to the healing process." One of the Center's major projects is the sponsoring of the Schwartz Center Rounds, a monthly, multidisciplinary forum in which caregivers discuss a specific cancer patient and the important psychosocial issues faced by the patient, family and caregivers. The forum allows caregivers to reflect on their experiences with patients and to gain support and insight from fellow staff members.

The following case discussion was addressed at the January 1998 Schwartz Center Rounds. In this article, the case will be presented, followed by verbatim dialogue from the rounds and a subsequent discussion of the relevant issues with emphasis on staff psychosocial issues.

J.T. was a 43-year-old man who developed adenocarcinoma of the lung and was treated at MGH. He died while participating in a phase I trial, resulting in marked frustration and distress among his caregivers. Staff questioned whether cancer patients entering phase I trials and their families receive unbiased information about the possible risks and benefits of the trial. They were also concerned about whether or not patients and their families really understand the physical and emotional risks of a trial. Moreover, they addressed whether patients are presented with alternatives to enrolling in a phase I trial, such as palliative care. Despite all these concerns, caregivers are reconciled to the belief that patients do value the opportunity to participate in phase I trials, in that they can contribute hope and meaning to other patients' struggles with cancer.

Key Words. Cancer • Phase I clinical trials • Informed consent • Caregivers • Psychosocial • Palliative care

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