Do Patients Participating In Oncology Clinical Trials Understand the Informed Consent Form?

Cancer Clinical Trial

Official title:

BrUOG 274: Do Patients Participating In Oncology Clinical Trials Understand the Informed Consent Form?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01772511
• Other study ID #: 274
• Status: Completed
• Phase: N/A
• First received: January 14, 2013
• Last updated: January 26, 2015
• Start date: March 2012
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer
• Neoplasms
• Oncology Problem

Intervention

Behavioral:
• Questionnaire
All patients entering on this trial will have been enrolled on an oncology clinical trial and are receiving active anti-cancer treatment on that study.

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Andrew Sch umacher

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Understanding of all elements of informed consent via questionnaire	Comprehension of the important elements of the informed consent forms using questionnaire	1 month	No
Secondary	Patient comprehension	Effectors of patient comprehension using questionnaire	every 6 months, up to 1 year	No