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PURPOSE:   Advanced cancer patients (ACP) hope to receive significant therapeutic benefit from phase I trials despite terminal disease and presumed symptom burdens. We examined associations between symptom burdens and expectations of therapeutic benefit for ACP and spousal caregivers (SC) during phase I trials.PATIENTS AND METHODS:   A prospective cohort of ACP-SC enrolled in phase I trials was assessed at baseline and one month using symptom burden measures evaluating depression, state-trait anxiety, quality of life, global health, post-traumatic coping, and marital adjustment. Interviews evaluated expectations of benefit.RESULTS:   Fifty-two phase I ACP and 52 SC (N = 104) were separately assessed and interviewed at baseline and one month. Total population demographics included the following: median age 61 years (28-78), 50% male, 100% married, 90% White, and 46% ≥ college education. At T1, ACP reported symptoms of mild state anxiety, mild trait anxiety, poor global health, and quality of life. SC reported moderate state and mild trait anxiety and good global health with little disability at baseline. State anxiety was a significant predictor of ACP expectations for phase I producing the following therapeutic benefits: stabilization ( P = .01), shrinkage ( P &lt; .01), and remission ( P = .04). Regression analyses also revealed negative associations between SC expectation for stabilization and SC anxiety: state ( P = .01) and trait ( P = .02). ACP quality of life was also negatively associated with SC expectations for stabilization ( P = .02) and shrinkage ( P = .01).CONCLUSION:   Anxiety, both state and trait, impacts couples’ beliefs regarding the likelihood of therapeutic benefit from phase I trial participation.

Anxiety Shapes Expectations of Therapeutic Benefit in Phase I Trials for Patients With Advanced Cancer and Spousal Caregivers