A care model led by advanced practice nurses was feasible in providing supportive care and linking providers through post-trial care transitions.
"Transitions" care plans included referrals to supportive and palliative care among other considerations.
An advanced practice nurse (APRN)-led model of care for improving the quality of life (QOL) of patients during the transition of care post phase 1 trial completion was found to be feasible and largely acceptable to both patients and oncologists, according to results from a pilot study.
The study, which observed a convenience sample of patients with gastrointestinal tumors, was conducted to develop and assess the feasibility of the “Transitions” care plan and assess its effect on QOL for this patient group on the bases of symptom management, psychosocial support, spiritual support, and care transition. Transitions evaluated patients’ understanding of their disease status and symptoms as well as plans for continued care.
“The APRN-led intervention provided a link between the oncologist, patient, and supportive care resources,” noted the study authors in the Journal of the Advanced Practitioner in Oncology, where the study was published. “The APRN was able to assess the status of symptom management, facilitate referral to supportive care services in the cancer center and to hospice.”
At the completion of a phase 1 clinical trial, an APRN and a medical oncologist evaluated each patient’s individual care transition plan as well as goals of care and other needs.
During the study accrual phase, an APRN reviewed patient cases weekly to select patients enrolled on the phase 1 trial for at least 1 month and monitored their statuses to gauge when a patient may complete the trial.
Following consent to participate in the Transitions care plan study, the APRN and medical oncologist collaborated to assess how the patient’s disease status, prognosis, and planned continued care would dictate care needs. The APRN then met with the patient to discuss who their providers would be following the phase 1 trial, what supportive care options were available, and advance care planning.
This stage of care planning included case management to determine who was responsible for continued care of the patient and referrals to services such as social work, spiritual/religious guidance, hospice, and palliative care, among others.
After these planning stages, the APRN presented the patient with a Transitions care plan with the help of the medical oncologist, if needed, and referred patients to the appropriate services for their individual care goals and needs.
A sample care plan was provided, detailing in patient-friendly terms that the patient’s stomach cancer has progressed and spread to the liver. This summarized the patient’s care needs, which, in this case, were pain management ahead of final travel to family and business planning with the patient’s son.
With consideration of the patient’s symptoms and pain level, the plan involved incorporating a regular schedule to pain medications the patient was sporadically receiving along with a referral to a palliative care consult for new pain symptoms.
Additionally, the plan addressed nausea subsiding after cessation of chemotherapy as well as numbness developing in the patient’s hands and feet during the trial with a review of the patient’s nausea medication and additional referral to palliative care, respectively.
The patient was determined to not have an advance care plan. The Transitions plan acknowledged that this stemmed from a hesitance to have that conversation with the patient’s wife and scheduled a meeting with a social worker to address these issues.
Lastly, the Transitions plan noted that care was being transferred from the trial care center to a center closer to the patient’s home due to the increasing difficulty of travel. The patient was informed in the plan that their community clinic doctor was sent a summary of treatment and care plans, and that the palliative care team would share recommendations with their doctor.
Feasibility and Unmet Needs
The study plan was feasible in its recruitment of patients, who largely expressed needs for support in their intake interviews. As noted by the researchers, some patients still wanted to continue treatment despite unlikelihood of clinical benefit.
“The study also illustrates the profound struggle of patients on clinical trials as they hope for new options for disease-focused care and prolonged life while also facing the reality of diminishing treatment options and often death within months of trial completion,” wrote the authors.
“This pilot study demonstrated the need for supportive care integration in the clinical trials population to address unmet needs and to facilitate this important time of transition in the cancer care trajectory.”
Ferrell BR, Borneman T, Zachariah F, Sun V, Co N, Chung V. Feasibility testing of an APRN-led model of care for transition of patients after completion of phase I trials. J Adv Pract Oncol. Published online May 3, 2025. doi:10.6004/jadpro.2025.16.7.12