Cancer, Oncology Problem
Conditions
Keywords
questionnaire, prior therapy, prior study volunteer, prior study patient, cancer, oncology
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.
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.
Interventions
BEHAVIORALQuestionnaire
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.
Sponsors
Andrew Sch umacher
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Understanding of all elements of informed consent via questionnaire | 1 month | Comprehension of the important elements of the informed consent forms using questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient comprehension | every 6 months, up to 1 year | Effectors of patient comprehension using questionnaire |
Countries
United States
Outcome results
None listed