Coping Strategies Among Early-Phase Cancer Clinical Trial Participants.

Abstract

Background: Individuals with cancer often use numerous coping strategies. However, little is known about coping behavior among patients enrolled on early-phase cancer clinical trials (EPCTs).

Methods: We prospectively enrolled adults with cancer initiating EPCTs at Massachusetts General Hospital from April 2021 to March 2025. Participants completed surveys at the time of EPCT enrollment assessing coping (Brief COPE [Coping Orientation to Problems Experienced]; scores range 0-6), quality of life (QoL; Functional Assessment of Cancer Therapy-General [FACT-G]), depression and anxiety symptoms (Patient Health Questionnaire-4 [PHQ-4]), symptom burden (Edmonton Symptom Assessment Scale [ESAS]), and financial well-being (Comprehensive Score for Financial Toxicity [COST]). We used regression models to explore associations of coping strategies with patient-reported and clinical outcomes.

Results: Among 195 participants enrolled, 188 completed the survey assessments (96.4% response rate). Among these participants (median age, 63.5 [range, 31.8-88.6]; 56.4% female), the most common cancer types were gastrointestinal (34.0%) and breast (20.7%). At the time of EPCT enrollment, patients' coping strategies included acceptance (mean Brief COPE score, 4.77), emotional support (mean score, 4.60), active coping (mean score, 4.25), positive reframing (mean score, 3.11), religion (mean score, 2.85), self-blame (mean score, 0.88), denial (mean score, 0.62), and behavioral disengagement (mean score, 0.35). Greater use of approach-oriented strategies (acceptance, emotional support, and positive reframing) and lower use of avoidant strategies (denial, self-blame, and behavioral disengagement) were associated with better QoL, fewer symptoms of depression and anxiety, lower symptom burden, and greater financial well-being (P<.05). Greater use of denial coping was associated with a lower risk of hospitalizations (hazard ratio [HR], 0.76; P=.007). Use of acceptance coping was associated with lower odds of completing the dose-limiting toxicity (DLT) period (odds ratio, 0.57; P=.023) and with a shorter time on trial (HR, 1.16; P=.011). Use of emotional support coping was associated with a shorter time on trial (HR, 1.13; P=.016) and worse survival (HR, 1.17; P=.005). Use of religion (HR, 1.09; P=.035) and positive reframing (HR, 1.11; P=.039) coping strategies was associated with worse survival.

Conclusions: In this cohort of EPCT participants, we found associations of coping behaviors with patient outcomes. Specifically, approach-oriented coping strategies correlated with higher QoL and lower distress. Interventions seeking to enhance outcomes in this population should target the diverse coping strategies used by EPCT participants.