Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials

NCT ID: NCT01946217

Last Updated: 2016-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-09-30

Brief Summary

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This pilot research trial studies factors affecting patient participation in Acquired Immune Deficiency Syndrome (AIDS) Malignancy Clinical Trials Consortium clinical trials. Determining how patients makes decisions about participating in a clinical trial may help doctors plan clinical trials in which more patients are willing to participate and are satisfied with their decision to participate.

Detailed Description

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PRIMARY OBJECTIVES:

I. To identify participant-level factors affecting recruitment of potentially eligible participants in AIDS Malignancy Clinical Trials Consortium (AMC) studies at core and affiliated sites.

SECONDARY OBJECTIVES:

I. To describe the socio-demographic characteristics for participation and non-participation in AMC clinical trials among all approached volunteers across AMC sites.

II. To characterize socio-demographic characteristics with motivation and decision making among those who consented to participate in an AMC trial.

III. To identify the perceived barriers associated with clinical trial participation among those who did not consent to participate in an AMC clinical trial.

IV. To better understand how potential study volunteers learn about AMC clinical trials and by what means are they referred to a particular study.

OUTLINE:

Participants complete the Improving Participation in AMC Clinical Trials (IMPACTS) survey comprising questions about socio-demographic information and clinical trial participation.

Conditions

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HIV Infection Malignant Neoplasm Precancerous Condition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (questionnaire administration)

Participants complete the IMPACTS survey comprising questions about socio-demographic information and clinical trial participation.

questionnaire administration

Intervention Type OTHER

Ancillary studies

Interventions

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questionnaire administration

Ancillary studies

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* HIV-infected participants
* Cancer or anal dysplasia diagnosis
* Offered informed consent on an AMC interventional clinical trial
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

* Inability to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

The Emmes Company, LLC

INDUSTRY

Sponsor Role collaborator

University of Arkansas

OTHER

Sponsor Role collaborator

AIDS Malignancy Consortium

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jack Burkhalter

Role: PRINCIPAL_INVESTIGATOR

AIDS Associated Malignancies Clinical Trials Consortium

Locations

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UCLA Clinical AIDS Research and Education (CARE) Center

Los Angeles, California, United States

Site Status

Stroger Hospital of Cook County

Chicago, Illinois, United States

Site Status

Interim LSU Public Hospital

New Orleans, Louisiana, United States

Site Status

HIV Out-patient Clinic

New Orleans, Louisiana, United States

Site Status

NO AIDS Clinic

New Orleans, Louisiana, United States

Site Status

Laser Surgery Care

New York, New York, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Albert Einstein Cancer Center at Albert Einstein College of Medicine

The Bronx, New York, United States

Site Status

Montefiore-Einstein Cancer Center

The Bronx, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Virginia Mason Medical Center

Seattle, Washington, United States

Site Status

Harborview Madison Clinic

Seattle, Washington, United States

Site Status

Seattle Cancer Care Alliance

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2013-01152

Identifier Type: REGISTRY

Identifier Source: secondary_id

AMC-S006

Identifier Type: OTHER

Identifier Source: secondary_id

AMC-S006

Identifier Type: OTHER

Identifier Source: secondary_id

U01CA121947

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AMC-S006

Identifier Type: -

Identifier Source: org_study_id

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