Clinical trial · Interventional
Consent Forms in Cancer Research: Examining the Effect of Length on Readability
NCT04548063CI-TRIAL-00080337completedN/AClinicalTrials.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)
Researchers are using mock consent forms to see if wordiness has any effect on patients' understanding and willingness to sign up for a cancer clinical trial.
Conditions
Conditions (1)
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 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2,000 word consent form | Other | — | UNRESOLVED |
| 4,000 word consent form | Other | — | UNRESOLVED |
| 6,000 word consent form | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 6,000 word consent form
- description
- Subjects who are receiving cancer therapy or have been treated for cancer in the past will be asked to review a mock consent form of approximately 6,000 words.
- interventionNames
- Other: 6,000 word consent form
- type
- EXPERIMENTAL
- label
- 4,000 word consent form
- description
- Subjects who are receiving cancer therapy or have been treated for cancer in the past will be asked to review a mock consent form of approximately 4,000 words.
- interventionNames
- Other: 4,000 word consent form
- type
- EXPERIMENTAL
- label
- 2,000 word consent form
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient-reported history of cancer * Patient is able to read English * Patient-reported age of 18 years or older Exclusion Criteria: * None
References
Publications (2)
- BACKGROUNDAlmodallal Y, Duong Q, Satele D, Novotny P, Cook KD, Chauhan C, Daiss MK, Le-Rademacher J, Looker S, Martin N, Smestad MF, Winham SJ, Mandrekar SJ, Jatoi A. Randomized, Double-Blind Trial on the Impact of Word Count in Cancer Clinical Trial Consent Forms. JCO Oncol Pract. 2021 Oct;17(10):e1460-e1472. doi: 10.1200/OP.21.00071. Epub 2021 Jun 14. PMID 34125586
- BACKGROUNDWieland J, Satele D, Almodallal Y, Novotny P, Pritzl SL, Mandrekar SJ, Jatoi A. Succinct Cancer Clinical Trial Consent Forms in Rural Patients With Cancer: A Secondary Analysis of a Randomized, Double-Blinded study. J Patient Exp. 2022 Jun 22;9:23743735221107242. doi: 10.1177/23743735221107242. eCollection 2022. PMID 35756962