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Facilitating enrollment in a Cancer Registry through modified consent procedures: a pilot study
Susan Mazanec1, Barbara Daly, Neal J Meropol
1School of Nursing, Case Western Reserve University, 10900 Euclid Avenue, Cleveland, OH44106-4904, USA. susan. mazanec@case.edu
Journal of Empirical Research on Human Research Ethics : JERHRE
|January 18, 2013
Summary
A simplified consent process using a registry booklet and tiered form improved enrollment for cancer research. This approach, while effective, requires in-person discussions and further testing for optimal patient participation.
Area of Science:
- Clinical Research
- Oncology
- Health Informatics
Background:
- Research registries are crucial for cancer centers but face enrollment challenges.
- Standard consent forms are often lengthy and complex, hindering participation.
- Efficient and ethical enrollment procedures are needed for effective data collection.
Purpose of the Study:
- To pilot test a simplified, tiered consent process for a cancer research registry.
- To assess the efficiency and patient acceptance of a registry booklet and one-page consent form.
- To evaluate the impact of a simplified consent on enrollment rates and data collection.
Main Methods:
- A pilot study involved 27 breast cancer patients receiving a registry booklet and simplified consent form.
- A research nurse facilitated informed consent and collected quality of life data.
- The study compared consent rates and patient feedback on the new process.
Main Results:
- The simplified consent process achieved a 78% consent rate, enrolling 21 patients.
- Patients who read the booklet beforehand found it easy to understand.
- The process was acceptable to patients and integrated into clinical operations.
Conclusions:
- An easy-to-read registry booklet can aid consent discussions for research participation.
- In-person consent procedures remain important for effective patient engagement.
- Further research is needed to optimize simplified consent approaches in clinical settings.
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