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.

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Key information

Conditions

Cancer Neoplasms Oncology Problem

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rhode Island Hospital, Providence, Rhode Island, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Behavioral

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 outcomes

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 outcomes

Patient comprehension

Time frame: every 6 months, up to 1 year

Effectors of patient comprehension using questionnaire

Sponsors and collaborators

Lead sponsor

Andrew Sch umacher

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Jan 21, 2013
Registry last updated: Jan 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed