The NCCN Oncology Research Program (ORP) strives to improve the quality of life for patients and reduce cancer-related deaths by advancing cancer therapies through research. Since the program’s establishment in 1999, the NCCN ORP has brought millions of dollars in research grants to investigators at NCCN Member Institutions. Research grants are provided to NCCN through collaborations with pharmaceutical and biotechnology companies; these grants are in turn used to support scientifically meritorious cancer research efforts.
NCCN ORP studies typically explore new avenues of clinical investigation and seek answers to important cancer-related questions. All studies are approved and funded through a scientific peer-review process and are overseen by the ORP.
This feature highlights an NCCN study funded through the grant mechanism.
Utilizing Patient-Reported Quality of Life to Inform Patient Decision-Making in Early-Stage Lung Cancer
Principal Investigator: Anurag K. Singh, MD; Sai Yendamuri, MD; Elizabeth Bouchard, MD
Condition: Non–small cell lung cancer: quality of life
Institution: Roswell Park Comprehensive Cancer Center
Currently, patients with peripheral, early-stage non–small cell lung cancer (NSCLC) can be treated with surgery or stereotactic body radiation therapy (SBRT). Patients with medically inoperable NSCLC receive SBRT. However, there are many patients who are deemed operable but for whom surgery poses increased risk and therefore SBRT is a reasonable option. For these patients, it is unclear whether surgery or SBRT provides better outcomes. Recent and ongoing clinical trials have attempted to randomize patients to surgery or radiation. Patients have been hesitant to allow randomization given the invasive nature of surgery and the noninvasive nature of SBRT; consequently, study recruitment has been difficult. Because evidence from randomized trials is unlikely to be available soon, this study focuses on factors other than oncologic outcomes but that are nevertheless important to patients.
Current usual care discussions involve patient–physician decision-making and discussion about the indications for, logistics of, and side effects of surgery/radiation. This includes a discussion of the mechanism of action of radiation, different surgical approaches, expected outcome, and follow-up procedures after the treatments. The usual care consultation takes approximately 1 hour and may occur within 4 weeks prior to receipt of the actual treatments. Currently, there is limited research regarding changes in treatment preference after the quality of life (QoL) discussion, because usual care can include a discussion of QoL at the treating physician’s discretion, and significant changes in treatment preference may not be likely.
The focus of this study is to identify differences in QoL measures with SBRT, lobectomy, and wedge resection for patients and to further assess the utility of presenting these data to patients making this choice. Socioeconomic status (SES) has already been shown to be significantly correlated with lung cancer incidence, QoL, and outcomes. Moreover, it is known that QoL significantly impacts patients’ decision regret regarding chemotherapy use in lung cancer. Therefore, the interaction between QoL and the utility of presentation of data with SES will also be explored. The utility of the information will be assessed using measures of decision regret at 1-, 3-, and 6-month time points after treatment delivery. General main points regarding QoL that are discussed: (1) a recent systematic review has shown that there is a lack of high-quality, randomized controlled trials on QoL in patients receiving surgery versus SBRT; (2) several studies have shown a decline in QoL at 1 month after surgery, but patients were able to recover and return to baseline afterward; and (3) one small randomized, controlled trial (ROSEL) reported that 22 patients had better overall health/QoL with SBRT, but all other QoL metrics were similar. The QoL data used for the current study are from existing literature as well as data from Roswell Park Comprehensive Cancer Center.
One prominent way that SES shapes patients’ treatment decision-making is through information-seeking and decision-making processes. SES shapes a patient’s likelihood of gathering independent information, the nature of the information gathered, and the information sources and credibility. Therefore, interventions that reduce disparities in access to high-quality information may reduce SES-related disparities through enhancing patients’ abilities to make evidence-informed treatment decisions. We hypothesize that presenting QoL data in a more patient-centered manner with a decision aid tool (such as a fact sheet) will reduce decision regret, and that this effect will be stronger for patients with lower income and education. The overarching goal of this project is to understand whether providing QoL outcome data to patients deciding between surgery and SBRT helps decrease decision regret and increase patient satisfaction with their care.
Primary Objective/Aim:
• Determine whether providing QoL information versus usual care to patients deciding between standard-of-care surgery or SBRT has an effect on decision regret
Contacts: Anurag K. Singh, MD • Anurag.Singh@RoswellPark.org
Sai Yendamuri, MD • Sai.Yendamuri@roswellpark.org
Elizabeth Bouchard, MD • Elizabeth.Bouchard@RoswellPark.org
ClinicalTrials.gov Identifier: NCT05292521
