Study of Decision Making in Patients Participating in Pha... | NCT00054223

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Not provided

Completion Date

Nov 2005Actual

First Submitted Date

Feb 5, 2003

First Submission Date that Met QC Criteria

Feb 5, 2003

First Posted Date

Feb 6, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2012

Last Update Posted Date

Mar 16, 2012Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

Brief Summary

RATIONALE: Studying individuals who are enrolled in phase I clinical trials may help to improve the way in which clinical trials are conducted.

PURPOSE: This clinical trial is studying patients' personality traits, reasons for participating in the trial, and understanding of their medical situation, prognosis, and risks and benefits of participating in a phase I trial.

Detailed Description

OBJECTIVES:

Determine the range of personality traits of patients enrolled in a phase I clinical trial.
Determine these patients' understanding of their medical situation and prognosis.
Determine these patients' understanding of risks and benefits of phase I clinical trials.
Determine these patients' reasons for participating in a phase I clinical trial.
Determine the risk/benefit trade-offs of these patients.
Determine the existential outlook of these patients.
Determine the information gathering nature of these patients.

OUTLINE: This is a multicenter study.

Before beginning phase I clinical trial treatment, patients complete a survey over 30-45 minutes administered by an interviewer. Patients then self-administer the Temperament and Character Inventory assessment over 30 minutes.

PROJECTED ACCRUAL: Approximately 250 patients will be accrued for this study within 6 months.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Name	Type	Description	Arm Group Labels	Other Names
psychosocial assessment and care	Procedure

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Consented to enrollment in a phase I cancer clinical 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

Understands written English

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Other

No concurrent enrollment in other clinical trials evaluating phase I patient attitudes

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Type	Description	Link
03-CC-0063
CDR0000269911

ID	Term
D012046	Rehabilitation
D013812	Therapeutics
D006296	Health Services
D005159	Health Care Facilities Workforce and Services