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

Completed

• Conditions: Oncology Problem; Cancer
• Interventions: Behavioral: Questionnaire

• Registration Number: NCT01772511
• Lead Sponsor: Andrew Sch umacher

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 Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-01-14
• Study First Submitted QC: 2013-01-18
• Study First Posted: 2013-01-21
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2014-12
• Last Update Submitted: 2015-01-26
• Last Update Posted: 2015-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Questionnaire	Questionnaire	Patients will be asked by a member of the research team if they would like to participate in this study evaluating patients' comprehension of the informed consent for the oncology treatment study that they are participating in. Patients will be consented and will be told that, at their next clinical visit, they will be given the questionnaire to complete. They will be given the option to complete the questionnaire on site after being given the document or have the ability to mail the completed questionnaire into the research office once completed. If the questionnaire is not returned within 2-weeks, the participant will be approached again during their normal clinical visit and asked if they still wish to participate in this study.

Primary Outcome Measures

Name	Time	Method
Understanding of all elements of informed consent via questionnaire	1 month	Comprehension of the important elements of the informed consent forms using questionnaire

Secondary Outcome Measures

Name	Time	Method
Patient comprehension	every 6 months, up to 1 year	Effectors of patient comprehension using questionnaire

Trial Locations

Locations (2)

The Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States