Evaluating Patient Participation in Phase I Clinical Trials

NCT00043030 | Completed

• 3 other identifiers: 02020402-C-0204CDR0000069497
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

psychosocial effects of cancer and its treatment; unspecified adult solid tumor, protocol specific

Outcome Measures

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 (6)

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

• 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

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

• 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

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

Interventions

psychosocial assessment and care PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Interventions

Psychiatric Rehabilitation

Intervention Hierarchy (Ancestors)

Rehabilitation; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Arlene Berman, RN, MS, OCN

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 5, 2002
• First Posted: January 27, 2003
• Study Start: June 1, 2002
• Primary Completion: December 1, 2006
• Study Completion: May 1, 2009
• Last Updated: March 15, 2012

Record last verified: 2012-03

Locations

US (1)