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

AIDS Malignancy Consortium

Status: Completed

Conditions: Malignant Neoplasm; Precancerous Condition; HIV Infection

Treatments: Other: questionnaire administration

Study type: Observational

Funder types: Other; NETWORK; Industry; NIH

Identifiers

NCT01946217

U01CA121947 (U.S. NIH Grant/Contract)

NCI-2013-01152 (Registry Identifier)

AMC-S006 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

82 participants in 1 patient group

Observational (questionnaire administration)

Description:

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

Treatment:

Other: questionnaire administration