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

This study is currently recruiting participants.
Verified March 2014 by AIDS Malignancy Clinical Trials Consortium
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT01946217
First received: September 17, 2013
Last updated: March 19, 2014
Last verified: March 2014

September 17, 2013
March 19, 2014
September 2013
December 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01946217 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials
Improving Participation in AMC Clinical Trials (IMPACTS)

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • HIV Infection
  • Malignant Neoplasm
  • Precancerous Condition
Other: questionnaire administration
Ancillary studies
Observational (questionnaire administration)
Participants complete the IMPACTS survey comprising questions about socio-demographic information and clinical trial participation.
Intervention: Other: questionnaire administration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
United States
 
NCT01946217
AMC-S006, NCI-2013-01152, AMC-S006, AMC-S006, U01CA121947
No
AIDS Malignancy Clinical Trials Consortium
AIDS Malignancy Clinical Trials Consortium
National Cancer Institute (NCI)
Principal Investigator: Jack Burkhalter AIDS Associated Malignancies Clinical Trials Consortium
AIDS Malignancy Clinical Trials Consortium
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP