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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Consortium
ClinicalTrials.gov Identifier:
NCT01946217
First received: September 17, 2013
Last updated: September 2, 2015
Last verified: September 2015
  Purpose

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.


Condition Intervention
HIV Infection
Malignant Neoplasm
Precancerous Condition
Other: questionnaire administration

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving Participation in AMC Clinical Trials (IMPACTS)

Resource links provided by NLM:


Further study details as provided by AIDS Malignancy Consortium:

Primary Outcome Measures:
  • Participant level factors affecting recruitment of potentially eligible participants in AMC intervention studies [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: No ]
    The proportion of individuals who are screened and agree to enroll in a clinical trial will be estimated with the binomial proportion and its 95% confidence interval.


Secondary Outcome Measures:
  • Socio-demographic characteristics for participation and non-participation in AMC clinical trials among all approached volunteers across AMC sites [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: No ]
    Chi-square tests will be used to compare the characteristics of those who enrolled in a clinical trial with those who did not with respect to sociodemographic characteristics, sexual orientation, and disease-type and design type.

  • Socio-demographic characteristics with motivation and decision making among those who consented to participate in an AMC trial [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: No ]
    Chi-square tests will be used to compare the characteristics of those who enrolled in a clinical trial with those who did not with respect to sociodemographic characteristics, sexual orientation, and disease-type and design type.

  • Perceived barriers associated with clinical trial participation among those who did not consent to participate in an AMC clinical trial [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: No ]
    For each study participant who did not enroll in a trial, the number of barriers in each category (views and attitudes, views of other people around them, financial burden and travel) will be computed. Summary statistics (mean, standard deviation [SD], median and interquartile range) will be used to estimate number of barriers in each category. Analyses of variance will be used to assess the associations of sociodemographic characteristics, sexual orientation, disease-type and design-type with the number of barriers in each category.

  • Means by which volunteers are referred to a particular study [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: No ]
    For study participants who enrolled in a clinical trial, the binomial proportion will be used to estimate the proportion who answered affirmatively to each of the six statements related to decision-making about clinical trials, and the individual reasons for participating in clinical trials. For each study participant who enrolled in a trial, the number of reasons cited for participation will be computed. Summary statistics mean, SD, median and interquartile range) will be used to estimate number of reasons cited for enrollment.


Estimated Enrollment: 100
Study Start Date: September 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observational (questionnaire administration)
Participants complete the IMPACTS survey comprising questions about socio-demographic information and clinical trial participation.
Other: questionnaire administration
Ancillary studies

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HIV-infected persons with a diagnosis of anal dysplasia or cancer who are offered informed consent on an AMC interventional clinical trial.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01946217

Locations
United States, California
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, United States, 90024
United States, Illinois
Stroger Hospital of Cook County
Chicago, Illinois, United States, 60612
United States, Louisiana
HIV Out-patient Clinic
New Orleans, Louisiana, United States, 70119
Interim LSU Public Hospital
New Orleans, Louisiana, United States, 70112
NO AIDS Clinic
New Orleans, Louisiana, United States, 70119
United States, New York
Montefiore-Einstein Cancer Center
Bronx, New York, United States, 10461
Montefiore Medical Center
Bronx, New York, United States, 10467
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Laser Surgery Care
New York, New York, United States, 10010
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Harborview Madison Clinic
Seattle, Washington, United States, 98104
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Sponsors and Collaborators
AIDS Malignancy Consortium
The EMMES Corporation
Investigators
Principal Investigator: Jack Burkhalter AIDS Associated Malignancies Clinical Trials Consortium
  More Information

No publications provided

Responsible Party: AIDS Malignancy Consortium
ClinicalTrials.gov Identifier: NCT01946217     History of Changes
Other Study ID Numbers: AMC-S006, NCI-2013-01152, AMC-S006, AMC-S006, U01CA121947
Study First Received: September 17, 2013
Last Updated: September 2, 2015
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Neoplasms
Precancerous Conditions

ClinicalTrials.gov processed this record on September 03, 2015