Guidelines Developed for Management of Phase I Trial Waiting Lists

February 1, 2002

SAN DIEGO--To relieve the anxiety and frustration cancer patients may feel when being put on a waiting list for enrollment into a phase I trial, clinical trials managers at Vanderbilt have developed wait list guidelines driven by compassion and ethics,

SAN DIEGO--To relieve the anxiety and frustration cancer patients may feel when being put on a waiting list for enrollment into a phase I trial, clinical trials managers at Vanderbilt have developed wait list guidelines driven by compassion and ethics, said Cindy Foss, BBA, program coordinator, and Teresa Knoop, RN, MSN, AOCN, cancer information nurse specialist and director of the Cancer Information Program (CIP), Vanderbilt-Ingram Cancer Center, Nashville.

Ms. Foss and Ms. Knoop addressed this philosophy and the program born out of it at the 26th Annual Conference of the Oncology Nursing Society (ONS abstract 90).

The Vanderbilt-Ingram Cancer Center opened a dedicated phase I clinical trials office in 1998. "We wanted a fair and reasonable way for patients to have access to those slots," Ms. Knoop said. "Phase I trials are especially limited because, as safety studies, they move slowly. There can be fewer slots available because no other trials are going on in that area or because the drug company imposes restrictions."

The Cancer Center receives patient referrals from physicians at their institution and from the neighboring communities. Waiting lists are a necessity, and placement on the list is based on the date the referral is received. "We do it that way to avoid favoritism or judgments," Ms. Foss said. "It’s the only fair way to go about it."

Ms. Foss and Ms. Knoop developed additional strategies to create a fair and compassionate waiting list process. These include a centralized system for both internal and external referrals, standardized forms, and procedures for keeping patients, families, and physicians fully informed.

Generally, a physician will contact the CIP about clinical trial availability. CIP will confirm receipt of the inquiry and request a completed referral form for review. CIP then provides the physician with information about trial availability and the time frame, at which point the patient is placed on the wait list and given CIP as a contact for any questions or information.

As part of the program, CIP also inserted a platform of ethical behavior that addresses the issues of autonomy, beneficence, compassion, and justice.

"Patients are told up front about the wait list; they know what the process is and can choose not to participate. That gives them autonomy," Ms. Knoop said.

Patients are kept current about their position on the list and given any information CIP has about the time frame. "We make sure that the physician is apprised, and we do as thorough a prescreen as possible to make sure the patient is eligible for the trial," Ms. Knoop said.

Ms. Knoop adds that patients are encouraged to call CIP using a toll-free number with any questions they may have, and that CIP staff make an effort to handle each call with patience and sensitivity, and to develop a trust relationship with each caller as he or she awaits trial screening. The patient is also given accurate information and guidance regarding insurance issues.

"The feedback we’re getting," Ms. Foss said, "is that the patients feel that there is someone here who cares."