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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Brown University
Sponsor:
Information provided by (Responsible Party):
Andrew Sch umacher, Brown University
ClinicalTrials.gov Identifier:
NCT01772511
First received: January 14, 2013
Last updated: January 18, 2013
Last verified: October 2012
  Purpose

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 Intervention
Cancer
Oncology Problem
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: BrUOG 274: Do Patients Participating In Oncology Clinical Trials Understand the Informed Consent Form?

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Understanding of all elements of informed consent via questionnaire [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Comprehension of the important elements of the informed consent forms using questionnaire


Secondary Outcome Measures:
  • Patient comprehension [ Time Frame: every 6 months, up to 1 year ] [ Designated as safety issue: No ]
    Effectors of patient comprehension using questionnaire


Estimated Enrollment: 75
Study Start Date: March 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cancer clinic

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772511

Contacts
Contact: Kayla Rosati 401-863-3000 Kayla_Rosati@brown.edu

Locations
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: kayla rosati    401-863-3000    kayla_Rosati@brown.edu   
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: kayla rosati    401-863-3000    kayla_rosati@brown.edu   
Sponsors and Collaborators
Andrew Sch umacher
Investigators
Principal Investigator: Andrew Schumacher Brown University
  More Information

No publications provided

Responsible Party: Andrew Sch umacher, Principal Investigator, Brown University
ClinicalTrials.gov Identifier: NCT01772511     History of Changes
Other Study ID Numbers: 274
Study First Received: January 14, 2013
Last Updated: January 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brown University:
questionnaire
prior therapy
prior study volunteer
prior study patient
cancer
oncology

ClinicalTrials.gov processed this record on July 20, 2014