Alzheimer Disease, Cancer
Conditions
Keywords
Informed consent, Key information, Common Rule, Research ethics
Brief summary
The investigators plan to conduct a stepped wedge randomized control trial to implement and test the consent template and process in three studies. Randomization will occur at the research coordinator/research team level. Each participating research team member will begin in the standard consent arm of the study. Subsequently, they will be randomized to the visual key information page arm at staggered time points to undergo training and begin using the visual key information page with patients who are eligible for the selected research study.
Interventions
OTHERVisual consent
Visual key information page
OTHERStandard consent
Summary text only
Sponsors
Washington University School of Medicine
Agency for Healthcare Research and Quality (AHRQ)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
This is a stepped wedge randomized control trial to implement and test the consent template and process in three studies. Randomization will occur at the research coordinator/research team level. Each participating research team member will begin in the standard consent arm of the study. Subsequently, they will be randomized to the visual key information page arm at staggered time points to undergo training and begin using the visual key information page with patients who are eligible for the selected research study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Eligibility Criteria for Patients: * Adult participants (18+) eligible for one of three participating trials at Washington University, University of Utah, or University of North Carolina at Chapel Hill. The eligibility criteria for the main trials are below: * UNC: * Basal-like PDAC Treated with Gemcitabine, Erlotinib, and Nab-paclitaxel (PANGEA) trial inclusion criteria: * Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information. * Participant is willing and able to comply with study procedures based on the judgment of the investigator. * Age ≥ 18 years at the time of consent. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. * Consent to a mandatory pre-study biopsy if archival tissue is not available or sufficient. * Participants 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. * Washington University: * Returning Research Results That Indicate Risk of Alzheimer Disease Dementia to Healthy Participants in Longitudinal Studies (WeSHARE) * Participants of the Knight Alzheimer Disease Research Center. * Participants with available results from an Alzheimer Disease blood biomarker test. * Participants who agreed to be contacted for additional research studies. * University of Utah: * Huntsman Cancer Institute Total Cancer Care * Participants who have been diagnosed with any type of tumor or cancer. * Participants with genetic predispositions or family history of cancer or tumors. * Participant volunteers willing to share samples and data for research. Eligibility Criteria for Research Staff: * Research staff/coordinators of one of the three participating trials at Washington University, University of Utah, or University of North Carolina at Chapel Hill.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in feasibility (FIM) of implementation (Research Staff only) | From baseline to end of study (estimated to be 4 months) | 4 items on a Likert scale ranging from completely disagree to completely agree. Higher scores indicate greater feasibility. (1=completely disagree, 3= neither agree nor disagree, 5= completely agree) |
| Change in acceptability (AIM) of implementation measures (Research Staff only) | From baseline to end of study (estimated to be 4 months) | 4 items on a Likert scale ranging from completely disagree to completely agree. Higher scores indicate greater acceptability. (1=completely disagree, 3= neither agree nor disagree, 5= completely agree) |
| Change in appropriateness (IAM) of implementation measure (Research Staff only) | From baseline to end of study (estimated to be 4 months) | 4 items on a Likert scale ranging from completely disagree to completely agree. Higher scores indicate greater appropriateness. (1=completely disagree, 3= neither agree nor disagree, 5= completely agree) |
| Change in organizational willingness and ability to implement strategies (Research staff only) | From baseline to end of study (estimated to be 4 months) | Measure of organizational readiness for engagement (MORE) measure; 4-point scale (1=not willing, 4=; willing) report mean and SD; higher scores indicate higher level of readiness |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge of information provided in the consent (Participant only) | At time of consent review (day 1) | The investigators will ask up to7 true/false/unsure questions. Missing responses will be considered false/incorrect. An overall knowledge score will be calculated with the percentage of items correctly answered. Higher scores indicate greater participant understanding of the clinical trial. |
| Satisfaction of information provided in the consent (Participant only) | At time of consent review (day 1) | NIH Health Information National Trends Survey (HINTS); 5-items on a Likert scale (1=completely disagree, 3= neither agree nor disagree, 5= completely agree). Higher scores indicate higher satisfaction. |
| Decisional conflict (Participant only) | At time of consent review (day 1) | SURE measure; 4-item measure. Scores less than equal to 3 indicate the presence of decisional conflict |
| Number of enrollments to clinical trials (Participant only) | At time of consent review (day 1) | The investigators will document whether or not participants enroll in the trials. |
Countries
United States
Outcome results
None listed