Abstract
BACKGROUND: Decision regret (DR) (distress or remorse after a treatment decision) has received limited examination in older adults with advanced cancer. The authors hypothesized that DR would change over time and be associated with worse patient-reported outcomes (PRO) and clinician-rated tolerability metrics over 6 months. METHODS: Adults aged 70+ with advanced cancer planning to receive systemic treatment were recruited from a national trial (GAP70+, NCT02054741). DR level (none (0), mild [1-25], and moderate/severe [>25]) and PROs (symptoms, functional status, and satisfaction with treatment) were assessed at 4-6 weeks, 3 months, and 6 months after treatment initiation and compared with ANOVA. Associations between clinician-rated grade >3 toxicities, and treatment-related hospitalizations and DR were examined with longitudinal linear mixed modeling. RESULTS: Data from 623 patients (M = 77 years, 43% female, mixed diagnoses) who completed the DR scale at least once were analyzed. At 4-6 weeks, mean DR was 17.1 (SD = 15.7), with 50% reporting mild DR and 21% moderate/severe DR. Patients experiencing higher DR reported significantly higher concurrent symptom severity, lower functional scores, and lower treatment satisfaction (all p < .05). At 6 months, mean DR was 3.9 points higher (95% confidence interval [CI], 1.1-6.7, p = .006) in patients with any grade >3 toxicities and 6.8 points higher (95% CI, 3.4-10.2, p < .001) in patients with treatment-related hospitalization. CONCLUSIONS: DR changes over time and is associated with worse PROs and clinician-rated toxicity. Clinicians can discuss DR and poor tolerability in conversations about high-risk cancer treatment with older adults who have advanced cancer. CLINICAL TRIALS REGISTRATION: NCT02054741.