COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01772511
Recruitment Status : Completed
First Posted : January 21, 2013
Last Update Posted : January 27, 2015
Information provided by (Responsible Party):
Andrew Sch umacher, Brown University

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.

Condition or disease Intervention/treatment
Cancer Oncology Problem 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BrUOG 274: Do Patients Participating In Oncology Clinical Trials Understand the Informed Consent Form?
Study Start Date : March 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Patient comprehension [ Time Frame: every 6 months, up to 1 year ]
    Effectors of patient comprehension using questionnaire

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cancer clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01772511

Layout table for location information
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
The Miriam Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Andrew Sch umacher
Layout table for investigator information
Principal Investigator: Andrew Schumacher Brown University

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Andrew Sch umacher, Principal Investigator, Brown University Identifier: NCT01772511    
Other Study ID Numbers: 274
First Posted: January 21, 2013    Key Record Dates
Last Update Posted: January 27, 2015
Last Verified: December 2014
Keywords provided by Andrew Sch umacher, Brown University:
prior therapy
prior study volunteer
prior study patient
Additional relevant MeSH terms:
Layout table for MeSH terms