Protocol Number: 02-C-0204

Title:

Survey of Patients' Motivations, Perceptions, and Expectations in Phase I Clinical Trials

Number:

02-C-0204

Summary:

Cancer patients who have exhausted standard therapy often find they have limited options. One option is to enroll in phase I clinical trials designed to evaluate investigational treatments. Phase I clinical trials involve the first use in humans of an investigational drug. Although these trials are closely monitored, there is minimal information about safety, toxicity and efficacy in humans. This lack of information makes it impossible to present the patient with a clearly defined assessment of the potential risks and benefits of the trial. There is concern that the terminally ill may be vulnerable and therefore cannot act voluntarily because of their desperate emotional state.

This study will evaluate patients' motivations, expectations, and perceptions regarding participation in phase I clinical trials. An analysis and characterization of these factors could be used to develop tools to help patients through the process of informed consent and lessen their fear and anxiety. A questionnaire was developed to ascertain patients' motivation (the factors that influence the patient to participate), expectation (expected benefit), and perception (his or her understanding of the purpose of the trial).

Secondary objectives include:

- to assess the influence of age and education on perception of phase I clinical trials.

- to assess the difference between patients who had previously participated and those who have not.

- to assess whether patients' perceptions, expectations, and motivations change while they are participating in a trial.

- to validate an interviewer-administered tool measuring patients' perceptions, motivations, and expectations.

- to assess patients' perceptions of the information they were given.

- to assess the influence of gender on perception of phase I clinical trials.

Patients must be 18 or older, within 1 week of enrolling of the phase I clinical trial, have the ability to follow basic verbal instructions as witnessed by the investigator or representative, be able to understand and speak English, have access to a phone, and have signed the informed consent for a phase I clinical trial. Patients will be interviewed again 2 months later. The first 10 patients will not be asked to do this second interview but will be asked additional questions to help improve the questionnaire.

Use of an ID number will help ensure confidentiality. The questionnaire has 24 questions and takes 30-45 minutes to complete. Some of the interviews will be monitored for quality assurance.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Completed Study; data analyses ongoing

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Questionnaire

Benefit

Recruitment Keyword(s):

Cancer

Questionnaire

Condition(s):

Cancer

Investigational Drug(s):

None

Investigational Device(s):

None

Interventions:

None

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Sachs GA Opportunities for promoting palliative medicine in cancer research Cancer Invest 1998;16(7):503-8 No abstract available PMID: 9774957

Daugherty CK Informed consent, the cancer patient, and phase I clinical trials Cancer Treat Res 2000;102:77-89 No abstract available PMID: 10650482

Daugherty CK Impact of therapeutic research on informed consent and the ethics of clinicaltrials: a medical oncology perspective J Clin Oncol 1999 May;17(5):1601-17 PMID: 10334550

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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