Expectations and experiences of patients with cancer participating in phase I clinical trials.
OBJECTIVE
To describe the expectations and experiences of patients entering phase I clinical trials.


METHODS
Descriptive, exploratory, prospective.


METHODS
A large military medical teaching center.


METHODS
Thirty-seven adult patients completed the entry and exit interviews. Subjects had a good performance status, were middle aged, and had common tumor types.


METHODS
Interviews using structured entry and exit questionnaires.


METHODS
Expectations and experiences of patients in phase I clinical trials.


RESULTS
Patients expected slightly increased support from family members and received more support than expected. Patients' expectations for tumor response and increased communication with their physician were not met. Patients expected symptoms such as fatigue, nausea and vomiting, and weight loss to improve during therapy, yet their expectations were not met.


CONCLUSIONS
One theme that emerged from the data was hope/optimism. An issue that needs further exploration is the extent to which patients accurately understand information in the consent form. Findings also support the importance of communication between the patient and family members and the healthcare team.


CONCLUSIONS
Oncology nurses can mediate the flow of information between physicians and patients. Oncology nurses can and should assess the patient's level of understanding of the clinical trial, the consent form, and potential side effects at the time of entry into the trial and intermittently during the course of therapy. Nurses must allow patients with cancer who are undergoing investigational therapy to maintain a level of hope, while realistically counseling them about their progress during phase I trial participation.
Yoder
L H
LH
Army Nurse Corps, Brooke Army Medical Center, Fort Sam Houston, TX, USA.
O'Rourke
T J
TJ
Etnyre
A
A
Spears
D T
DT
Brown
T D
TD
D000328:Adult; D000368:Aged; D001294:Attitude to Health; D017321:Clinical Trials, Phase I as Topic; D003142:Communication; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy* / Q000451:nursing / Q000523:psychology*; D015404:Nursing Methodology Research; D010817:Physician-Patient Relations; D011446:Prospective Studies; D012944:Social Support; D011795:Surveys and Questionnaires; D016896:Treatment Outcome