Brief Summary
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.
Brief Title
Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
HIV Infection
Malignant Neoplasm
Precancerous Condition
Eligibility 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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01946217
Org Class
Network
Org Full Name
AIDS Malignancy Consortium
Org Study Id
AMC-S006
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Improving Participation in AMC Clinical Trials (IMPACTS)
Primary Outcomes
Outcome Description
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.
Outcome Measure
Participant level factors affecting recruitment of potentially eligible participants in AMC intervention studies
Outcome Time Frame
Up to 2 weeks
Secondary Ids
Secondary Id
NCI-2013-01152
Secondary Id
AMC-S006
Secondary Id
AMC-S006
Secondary Id
U01CA121947
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Up to 2 weeks
Outcome Measure
Socio-demographic characteristics for participation and non-participation in AMC clinical trials among all approached volunteers across AMC sites
Outcome Description
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.
Outcome Time Frame
Up to 2 weeks
Outcome Measure
Socio-demographic characteristics with motivation and decision making among those who consented to participate in an AMC trial
Outcome Description
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.
Outcome Time Frame
Up to 2 weeks
Outcome Measure
Perceived barriers associated with clinical trial participation among those who did not consent to participate in an AMC clinical trial
Outcome Description
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.
Outcome Time Frame
Up to 2 weeks
Outcome Measure
Means by which volunteers are referred to a particular study
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
HIV-infected persons with a diagnosis of anal dysplasia or cancer who are offered informed consent on an AMC interventional clinical trial.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Missak Haigentz
Investigator Email
mhaigent@montefiore.org
Investigator Phone
718-920-4826