Psychometric Evaluation of the ONNPA©

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The ONNPA© study (IRB-2024-04) is being led by Dr. Nora Flucke at Fort Lewis College in Durango, Colorado. The study is designed to test a newly developed assessment tool that supports the work of nurse navigators. Patients who might consider participating in this research have been recently referred to a cancer nurse navigator for care.

The study is being conducted to evaluate a new tool that helps oncology nurse navigators accurately identify patient barriers and needs with the goal of improving health outcomes in cancer care.

Patients may not receive an immediate or direct benefit from participating in this research study, However, the information gained from this study may benefit other people now or in the future.

There are no foreseeable risks from participating in the study beyond what patients can expect from a typical nurse navigation intake assessment for cancer care planning. No personal patient data will be collected and measures will be taken to minimize the potential risk of a data breach. The study will treat all patient data as confidential.

If a patient takes part in the study, the nurse navigator will share some anonymous assessment information with the researchers so that they can test if the new assessment tool works as intended. All patients’ identities will be protected in the study. 

The information that the navigator would share is part of a routine nurse navigator assessment. In this sense, no action or extra time is required from the patient to participate in the study.

If the patient agrees to participate in the study they would allow your nurse navigator to share the following information with the researchers completely anonymously: age, gender, race, zip code, occupation, insurance type, cancer type and stage, current distress score, and whether they have had a personal and family history of cancer. In addition, the nurse navigator would share information about the patient's needs or barriers to cancer care at the beginning and again at the end of the study.. 

Patients have the option to not let the nurse navigator share certain information and still remain in the study.

If a patient were to participate in the study, the nurse navigator would work with the patient as usual. However, after the first meeting, and again, right after the patient starts cancer treatment, the nurse navigator would share some of the assessment information as part of the study. The time span in between the first and the second assessments can vary but is expected to average 8 weeks. 

Patients are free to choose whether to become participants in the study. All patients who opt not to participate will receive nurse navigation services as usual.

There are no costs for participating in the study.

Patients are not paid as part of this study.  

All collected patient information will be stored anonymously.  There are no names associated with any assessment information. No master list of identifiable information will be kept.

Patient privacy is important to us, and we will follow federal and state privacy laws, including HIPAA. We will only use the health information we collect to conduct this research study. Solely the research team, the Fort Lewis College Institutional Review Board, and federal agencies that oversee research will have access to this information. A patient's permission to use the information that is collect for this research study will not expire unless the patient tells the nurse to cancel it. 

In the event that a patient suffers a research-related injury, the patient's medical expenses will be the patient's responsibility or that of the patient's third-party payer. However, patients can seek compensation for injury related to fault or blame on the part of those involved in the research. The Colorado Governmental Immunity Act determines and may limit Fort Lewis College’s legal responsibility if an injury happens because of this study. Claims against the College must be filed within 180 days of the injury. 

Participation is voluntary, and patients may refuse to participate in the study without penalty or discrimination at any time.  Patients may choose not to take part in this study or first decide to take part but later change their mind and withdraw. Withdrawal from the study is possible at any time at which point all information will be deleted.

All patients who want to participate in this study should sign an informed consent form or give verbal consent for the nurse to enter on the informed consent form.

Please direct any questions about the study at Dr. Flucke nflucke@fortlewis.edu.