BrUOG 274: Do Patients Participating In Oncology Clinical Trials Understand the Informed Consent Form?
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Andrew Sch umacher
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Understanding of all elements of informed consent via questionnaire
Overview
Brief Summary
The purpose of this study is to assess patients' understanding of clinical trials and to help researchers understand which areas of the informed consent need better explanation for future cancer clinical trial patients.
Detailed Description
Obtaining informed consent as part of a clinical study is a cornerstone of current day medical ethics; however, this has not always been the case. The development of the informed consent has been necessitated out of abuses committed in the name of medicine.
Informed consents have become increasing lengthy and complex. It is not unusual for an Oncology Clinical Research informed consent to be greater than 20 pages. Investigators will utilize the QuIC-A survey to evaluate patient understanding of the basic elements of informed consent required by federal regulations. The QuIC-A survey has been condensed from 20 questions to 14 questions by eliminating the 6 phase specific questions. The remaining 14 questions are designed irrespective of phase and address the basic elements of informed consent.
Investigators hypothesize that as informed consents have become more lengthy and complicated, in part due to required regulatory language and legal clauses inserted to protect the institution performing research, patient comprehension of the basic elements of informed consent has been hindered.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients \> 18 years of age
- •Patients are receiving active treatment on an oncology clinical trial that utilizes chemotherapy, radiation, targeted agents, biologic therapy or hormonal therapy
- •Patients must have been consented in English to an oncology treatment clinical study
Exclusion Criteria
- •Not meeting all eligibility criteria
Outcomes
Primary Outcomes
Understanding of all elements of informed consent via questionnaire
Time Frame: 1 month
Comprehension of the important elements of the informed consent forms using questionnaire
Secondary Outcomes
- Patient comprehension(every 6 months, up to 1 year)
Investigators
Andrew Sch umacher
Principal Investigator
Brown University