A Visual Template for the Improvement of the Consent Process for Participants Enrolling in Clinical Trials (AHRQ Aim 3)

Status: closed to accrual

This clinical trial is being done to understand how people feel about using a visual summary page as part of informed consent for research and whether a visual summary page helps people understand details of studies better. Informed consent is a process in which a person is given important facts about a medical procedure or treatment, a clinical trial, or genetic testing before deciding whether or not to participate. It also includes informing the patient when there is new information that may affect his or her decision to continue. Informed consent includes information about the possible risks, benefits, and limits of the procedure, treatment, trial, or genetic testing. Using a visual summary page as part of the informed consent may work better at enrolling participants in clinical trials.

Inclusion Criteria

Adult patients (18+) eligible for one of three participating trials at Washington University, University of Utah, or University of North Carolina at Chapel Hill
BASAL-LIKE PANCREATIC DUCTAL ADENOCARCINOMA (PDAC) TREATED WITH GEMCITABINE, EROLOTINIB, AND NAB-PACLITAXEL (PANGEA TRIAL) (UNIVERSITY OF NORTH CAROLINA [UNC]): Written informed consent was obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information. Subjects is willing and able to comply with study procedures based on the judgment of the investigator
BASAL-LIKE PANCREATIC DUCTAL ADENOCARCINOMA (PDAC) TREATED WITH GEMCITABINE, EROLOTINIB, AND NAB-PACLITAXEL (PANGEA TRIAL) (UNC): Age ≥ 18 years at the time of consent
BASAL-LIKE PANCREATIC DUCTAL ADENOCARCINOMA (PDAC) TREATED WITH GEMCITABINE, EROLOTINIB, AND NAB-PACLITAXEL (PANGEA TRIAL) (UNC): Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
BASAL-LIKE PANCREATIC DUCTAL ADENOCARCINOMA (PDAC) TREATED WITH GEMCITABINE, EROLOTINIB, AND NAB-PACLITAXEL (PANGEA TRIAL) (UNC): Consent to a mandatory pre-study biopsy if archival tissue is not available or sufficient
BASAL-LIKE PANCREATIC DUCTAL ADENOCARCINOMA (PDAC) TREATED WITH GEMCITABINE, EROLOTINIB, AND NAB-PACLITAXEL (PANGEA TRIAL) (UNC): Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen
RETURNING RESEARCH RESULTS THAT INDICATE RISK OF ALZHEIMER DISEASE DIMENTIA TO HEALTHY PARTICIPANTS IN LONGITUDINAL STUDIES (WeSHARE TRIAL) (WASHINGTON UNIVERSITY [WashU]): Participants of the Knight Alzheimer Disease Research Center (ADRC)
RETURNING RESEARCH RESULTS THAT INDICATE RISK OF ALZHEIMER DISEASE DIMENTIA TO HEALTHY PARTICIPANTS IN LONGITUDINAL STUDIES (WeSHARE TRIAL) (WashU): Patients with available results from an Alzheimer Disease blood biomarker test
RETURNING RESEARCH RESULTS THAT INDICATE RISK OF ALZHEIMER DISEASE DIMENTIA TO HEALTHY PARTICIPANTS IN LONGITUDINAL STUDIES (WeSHARE TRIAL) (WashU): Patients who agreed to be contacted for additional research studies
HUNTSMAN CANCER INSTITUTE TOTAL CANCER CARE (UNIVERSITY OF UTAH [UofU]): Patients who have been diagnosed with any type of tumor or cancer
HUNTSMAN CANCER INSTITUTE TOTAL CANCER CARE (UofU): Patients with genetic predispositions or family history of cancer or tumors
HUNTSMAN CANCER INSTITUTE TOTAL CANCER CARE (UofU): Patient volunteers willing to share samples and data for research
Principal investigators (PIs) and/or research staff of one of the three participating trials at Washington University, University of Utah, or University of North Carolina at Chapel Hill

PRIMARY OBJECTIVE:

I. To find out how people feel about using a visual summary page as part of informed consent for research.

OUTLINE:

ARM I: Research staff receive standard consent with text only on study.

Participants are randomized to 1 of 3 arms.

ARM II: Research staff receive training over 10-15 minutes in the consent process and use the visual consent template with patients on study. Research staff complete surveys providing feedback of the visual consent template process.

ARM III: Participants receive a visual consent template and complete a survey providing feedback of the template on study.

ARM IV: Participants receive a standard consent with text only on study and complete a survey providing feedback of the template on study.

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A Visual Template for the Improvement of the Consent Process for Participants Enrolling in Clinical Trials (AHRQ Aim 3)

Description

Eligibility Criteria

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Trial Objectives and Outline

Trial Phase & Type

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Trial IDs

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