Nurse-Led Sessions Enhance Supportive Care for Patients on Clinical Trials

“There are a group of nurses that are uniquely positioned to understand and maybe better identify what these supportive care needs might look like,” Lundquist said.

A nurse-led intervention to address supportive care concerns of patients with cancer taking part in an early phase clinical trial appeared to be useful, effective, and relevant, according to a pilot study presented at the 50th Annual ONS Congress.

“Clinical trials have always been geared in safety, looking to understand what’s the maximum tolerated dose…But what has happened over the last 10 years is that the landscape has changed dramatically…patients that are coming on clinical trials are actually staying on clinical trials longer than they were previously,” Debra M. Lundquist, PhD, RN, nurse scientist/clinical research nurse, The Henri and Belinda Termeer Center for Targeted Therapies, Massachusetts General Hospital in Boston, said during a presentation at the Congress.

“However, they often have advanced disease and have received multiple lines of therapy before they come to us. So they may also be already carrying disease- or treatment-related symptoms before they start their clinical trial, and they may be struggling with some of the psychosocial and existential concerns that really are present. They’re living with advanced cancer. They don’t know what their life expectancy looks like, but they know it is likely going to be shortened.”

Therefore, the study investigators aimed to address supportive care needs to improve quality of life (QOL), reduce symptoms, and facilitate access to new therapies through a nurse-led intervention.

“There are a group of nurses that are uniquely positioned to understand and maybe better identify what these supportive care needs might look like,” Lundquist said.

Research for Intervention

As part of their research, the investigators conducted a retrospective study to understand the utilization of supportive care across 10 services offered at their institution, finding that under half of participants used these services.

They then conducted a qualitative study to understand what is important to patients at early phase clinical trial enrollment.

Lastly, the investigators conducted a prospective study, which was presented at the Congress, of 8 patient-reported outcomes, which associated higher hope with QOL, symptom burden, adaptive coping, and financial well-being over the course of clinical trial participation.

The investigators prospectively enrolled patients, family caregivers, CRNs, and clinicians at an academic center from July 2023 to September 2024 to assess patients’ QOL, hope, symptom burden, coping, and nurse-patient relationship, as well as providers’ acceptability and feasibility of the nurse-led intervention.

Patients were eligible for the prospective study if they were 18 or older, were diagnosed with cancer, were enrolled in an early phase clinical trial, and were able to read and respond to questions in English. Caregivers were enrolled in the study if they had a relative or friend enrolled as the patient in the study, were 18 years of age or older, and were verbally fluent in English. Providers were included in the study if they were an oncology nurse, CRN for a minimum of 18 months, and were a full-time employee in the Termeer Center.

Nurse-Led Intervention

The clinical research nurses had 3 structured visits with patients when, at the time, they enrolled on the clinical trial.

The introduction in session 1 included a background of intentional relationship dynamics and nursing assessment format; an introduction to concepts of partnership, presence, and patterning; and a dialogue on expectations and previous experiences and cases.

The second session focused on implementation of a dialogue on experiences and cases, while reflecting on intentional relationship assessments and areas of insights and opportunities for new actions.

The third session, focusing on further development of skills, included dialogue on follow-up visits and communication while the patient remains on study; reinforcement concepts and relationship dynamics; and discussions and reflections on the nurse-patient relationship as an environment facilitating trust, opportunities to identify patients’ needs, and individualize patient care.

Exit interviews with patients comprised patient-centric collaboration, logistics, and unexpected outcomes, which also included a nurse-patient relationship scale.

Study Findings

Of the 50 patients who participated in the prospective study, median age was 58.7 years (range, 52.8-65.7), with the majority being female (60%), White (88%), and having and ECOG performance status of 1 (62%). Patients were diagnosed with a gastrointestinal cancer (n = 11), breast cancer (n = 7), gynecologic cancer (n = 5), head and neck cancer (n = 5), lung (n = 5), genitourinary cancer (n = 4), melanoma (n = 3), or sarcoma (n = 3).

Of the 25 caregivers who participated, median age was 57.3 years (range, 51.6-63.5), with the majority being female (72%), White (92%), married (92%), and employed (88%).

The mean score of the Acceptability of Intervention Measure (AIM) was 17.6 (range, 4-20), and the mean score of the Feasibility of Intervention Measure (FIM) was 17.7 (range, 4-20), with higher scores indicating greater acceptability and feasibility.

The nurse-patient relationship scale, completed by 22 patients, demonstrated a mean score of 92.9 (range, 17-102), with higher scores indicating the relationship with nurses as healing and transformative.

Lundquist concluded by noting that feasibility and acceptability ratings were high, with exit interviews underscoring the usefulness and relevance of the exit interviews. Lastly, she highlighted that future research can help to build upon this work to test nurse-led interventions targeting supportive care concerns.

Reference:

Lundquist DM. A nurse-led intervention to enhance quality of life among early phase cancer clinical trial participants. Presented at: 50th Annual ONS Congress; April 9-13, 2025; Denver, Colorado.