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Completed

NCT Number: NCT00043030

Evaluating Patient Participation in Phase I Clinical Trials

RATIONALE: Understanding why patients participate in a phase I clinical trial may help doctors plan better treatment for cancer.

PURPOSE: This clinical trial is studying to determine the reasons for participation, perceptions, and expectations of patients receiving treatment for cancer in phase I clinical trials.

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Key information

Conditions

Psychosocial Effects of Cancer and Its Treatment Unspecified Adult Solid Tumor, Protocol Specific

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

About this study

OBJECTIVES:

  • Describe the motivations, perceptions, and expectations of patients enrolled in a phase I clinical trial.
  • Assess the influence of age, education, and gender upon the perception of these patients.
  • Compare the difference in perceptions, motivations, and expectations of patients who have previously participated in a phase I clinical trial vs those who have not.
  • Determine whether patients' perceptions, motivations, and expectations change while enrolled in a phase I clinical trial.
  • Validate an interviewer-administered tool measuring the perceptions, motivations, and expectations of these patients.
  • Assess patients' perception of the information they were given while enrolled in a phase I clinical trial.

OUTLINE: Patients are interviewed over the phone to evaluate their perceptions, motivations, and expectations of phase I clinical trials. Patients complete a questionnaire comprising 24 questions over 30-45 minutes. Interviews are conducted within 1 week after enrolling in a phase I clinical trial (prior to the first dose of study agent) and then again 2 months later (or at the time the patient stops treatment). The first 10 patients enrolled complete an additional 6 questions over 15 minutes during the first interview to validate the questionnaire, but do not complete a second interview.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study within 1 year.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Enrolled in a phase I clinical trial within the past week
  • Signed an informed consent for a phase I trial

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Able to follow basic verbal instructions as witnessed by the investigator or a representative
  • Able to understand and speak English as determined by the investigator or a representative
  • Access to a telephone

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • Prior participation in a phase I clinical trial allowed

Treatment and study plan

psychosocial assessment and care

Procedure

Primary outcomes

  1. Patients' perceptions, motivations, and expectations as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial

Secondary outcomes

  1. Influence of age and education on perception as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial

  2. Compare difference between patients who have and who have not previously participated in phase I clinical trials as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial

  3. Changes in patients' perceptions, motivations, and expectations as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial

  4. Validate measurement of patients' perceptions, motivations, and expectations as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial

  5. Patient's perceptions of information given as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial

  6. Influence of gender upon perception as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial

Sponsors and collaborators

Lead sponsor

National Institutes of Health Clinical Center (CC)

Nih

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Survey Of Patient's Motivations, Perceptions, And Expectations In Phase I Clinical Trials

Important dates

Study start
2002
Primary completion
2006
Study completion
2009
First posted
Jan 27, 2003
Registry last updated
Mar 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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