Clinical trial NCT01772511: Do Patients Participating In Oncology Clinical Trials Understand the Informed Consent Form?
Official title: BrUOG 274: Do Patients Participating In Oncology Clinical Trials Understand the Informed Consent Form?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Oncology Problem
Keywords: questionnaire
prior therapy
prior study volunteer
prior study patient
cancer
oncology
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2013-01-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer clinic

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.

Eligibility criteria: 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

Primary outcomes:
measure: Understanding of all elements of informed consent via questionnaire
timeFrame: 1 month
Secondary outcomes:
measure: Patient comprehension
timeFrame: every 6 months, up to 1 year
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: Brown University
name: Andrew Schumacher
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schumacher A, Sikov WM, Quesenberry MI, Safran H, Khurshid H, Mitchell KM, Olszewski AJ. Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study. PLoS One. 2017 Feb 24;12(2):e0172957. doi: 10.1371/journal.pone.0172957. eCollection 2017.