Consent Forms in Cancer Research: Examining the Effect of Length on Readability
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-007236
NCT ID: NCT04548063
Sponsor Protocol Number: 20-007236
About this study
The objectives of this study are to determine whether cancer patients report that shorter, or less wordy, consent forms are helpful to them as they decide about whether or not to enroll in a cancer clinical trial, and to determine whether shorter consent forms result in a greater percentage of patients’ enrolling in a cancer clinical trial, based on whether or not the patient has signed a mock consent form.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patient-reported history of cancer.
- Patient is able to read English.
- Patient-reported age of 18 years or older.
Exclusion Criteria:
- Individuals under 18 years of age.
Eligibility last updated 5/17/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Aminah Jatoi, M.D. |
Closed for enrollment |
|
More information
Publications
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Rural patients are often underrepresented in cancer clinical trials. This is a secondary analysis of a study that tested short (2000 word) versus long (6000 word) consent forms with a focus on rurality. Among 240 patients, 89 (37%) were rural. Seventy-one (80%) rural and 117 (77%) nonrural patients signed a consent form of any length ( = .68). Forty-one of 47 (87%) rural patients signed a short consent form; in contrast, 30 of 42 (71%) signed a long form. These trends suggest rural patients are more likely to sign short consent forms. Further study is indicated.
Read More on PubMed
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This randomized, double-blind study sought to understand whether cancer clinical trial consent form verbosity detracts from patients' decision making on trial enrollment.
Read More on PubMed