Researchers developed an approach to medical consent for patients considering systemic anticancer therapy. This approach and a pilot study evaluating it were described by Fiona E. Barrett, Oncology Clinical Nurse Specialist at Beaumont RCSI Cancer Centre in Dublin, Ireland, in a European Oncology Nursing Society (EONS) session at the European Society for Medical Oncology (ESMO) Congress.

Ms Barrett explained in her presentation that consent involves educating a patient regarding benefits, risks, and alternatives to an intervention and assessing the patient’s understanding of the information given. “It’s also really important to remember that it’s more than just a patient’s signature on a piece of paper,” Ms Barrett said in her talk.

Many obstacles can affect the consent process, including attempting the process in a fast-paced environment or in the context of communication barriers. A patient may also have cognitive difficulties, difficulty with literacy, and/or experience information overload.


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The approach developed by Ms Barrett and colleagues, the 3-Stage Capacity-Consent Process, involves 3 visits with the patient. The first visit, on day 1, is with a senior medical oncologist at an outpatient clinic. The patient is assessed, and the oncologist speaks with the patient about their cancer, treatment options, and potential side effects and outcomes while discussing an appropriate treatment plan. The patient also meets with and receives additional information from an oncology liaison nurse on day 1.

Visits 2 and 3 are in the oncology day ward. At these visits, the patient is able to ask more questions and is provided with more information in the setting where treatment would occur. Patients participating in the pilot study described this as helpful. The staff asks the patient if they have read, remember, and understand the information they have received. Further information is given as needed. The patient next meets with the oncology registrar, who also provides additional information. If satisfied, the patient signs the consent form for medical treatment.

The pilot study was a nurse-led, prospective observational study examining the feasibility of the 3-stage process Ms Barrett and colleagues developed. It was conducted at an ambulatory care center in a tertiary referral hospital. Participants were adults with solid tumor malignancies who were to begin standard-of-care intravenous systemic therapy within 2 to 3 weeks.

The study included 126 patients, median age 65 years (range, 20 to 89). More than half (55%) were to receive cytotoxic chemotherapy, 32% were to receive immunotherapy, and 13% were to receive concurrent chemoradiation. Most (87%) patients were receiving first-line therapy and may therefore require more information that they must process, Barrett explained. Patients were being treated for a variety of cancer types.

“A 3-stage consent process allows for several phases of information processing time,” Ms Barrett explained in her presentation. The researchers concluded that the 3-stage process of consent in this pilot study was feasible, and they plan to expand the approach within their cancer center and perform additional research on it.

Disclosures: Some authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Reference

Barrett FE, Fitzpatrick OM, Doyle T, et al. Three stage capacity: consent process for systemic anti-cancer therapy. Ann Oncol. 2022;33(suppl_7):S818-S819. doi:10.1016/annonc/annonc1044