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

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Oncology Problem
• Intervention / Treatment: Behavioral: Questionnaire

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cancer clinic

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Understanding of all elements of informed consent via questionnaire	Comprehension of the important elements of the informed consent forms using questionnaire	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient comprehension	Effectors of patient comprehension using questionnaire	every 6 months, up to 1 year

Collaborators and Investigators

• Sponsor: Andrew Sch umacher
• Investigators: Principal Investigator: Andrew Schumacher, Brown University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: January 14, 2013
• First Submitted That Met QC Criteria: January 18, 2013
• First Posted (Estimate): January 21, 2013

Study Record Updates

• Last Update Posted (Estimate): January 27, 2015
• Last Update Submitted That Met QC Criteria: January 26, 2015
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: cancer; oncology; questionnaire; prior therapy; prior study volunteer; prior study patient
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 274