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

January 26, 2015 updated by: Andrew Sch umacher

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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
Time Frame: 1 month
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
Time Frame: every 6 months, up to 1 year
Effectors of patient comprehension using questionnaire
every 6 months, up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrew Sch umacher

Investigators

  • Principal Investigator: Andrew Schumacher, Brown University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 274

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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