Cancer
Conditions
Brief summary
Researchers are using mock consent forms to see if wordiness has any effect on patients' understanding and willingness to sign up for a cancer clinical trial.
Detailed description
This study will determine whether there is a relationship between wordiness of a consent form and whether or not the consent form helped the patient decide to enroll in a clinical trial. This study will also determine whether wordiness of a consent form is associated with patients' willingness to sign the consent form.
Interventions
OTHER6,000 word consent form
Mock consent form with consistent content in approximately 6,000 word length.
OTHER4,000 word consent form
Mock consent form with consistent content in approximately 4,000 word length.
OTHER2,000 word consent form
Mock consent form with consistent content in approximately 2,000 word length.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient-reported history of cancer * Patient is able to read English * Patient-reported age of 18 years or older
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decision to enroll | Through study completion, approximately 1 hour | Number of participants to indicate on the self-reported patient questionnaire that the information provided in the consent form helped make a decision about whether or not to enroll in the trial. This is defined as a response of 1 or 2 on the Likert scale of 1=strongly agree and 5= strongly disagree for information in the consent form was helpful to the decision to join the study. |
Countries
United States
Outcome results
None listed