Clinical trial · Observational
Do Patients Participating In Oncology Clinical Trials Understand the Informed Consent Form?
BrUOG 274: Do Patients Participating In Oncology Clinical Trials Understand the Informed Consent Form?
NCT01772511CI-TRIAL-00016706completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Oncology Problem | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Questionnaire
- description
- 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.
- interventionNames
- Behavioral: Questionnaire
Primary outcomes (1)
- measure
- Understanding of all elements of informed consent via questionnaire
- timeFrame
- 1 month
- description
- Comprehension of the important elements of the informed consent forms using questionnaire
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSchumacher A, Sikov WM, Quesenberry MI, Safran H, Khurshid H, Mitchell KM, Olszewski AJ. Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study. PLoS One. 2017 Feb 24;12(2):e0172957. doi: 10.1371/journal.pone.0172957. eCollection 2017. PMID 28235011