Cognitive behavioral digital therapeutic effects on distress and quality of life in patients with cancer: National randomized controlled trial.

Objective: Cancer-specific psychological interventions like cognitive behavioral stress management (CBSM) demonstrate distress (e.g., anxiety/depression) and quality of life (QoL) benefits. Digital formats can expand access.

Method: Patients (80.6% female; 76.5% White; 25-80 years) with Stage I-III cancer and elevated anxiety within 6 months of treatment (surgery/chemotherapy/radiation/immunotherapy) receipt were randomized 1:1 to a 10-module CBSM or health education control digital app and completed questionnaires at Weeks 0, 4, 8, 12. Primary outcomes of greater group-level anxiety (PROMIS-A) and depression symptom (PROMIS-D) reductions for CBSM were met and published; this secondary report evaluates individual-level response results for these outcomes and outcomes beyond anxiety and depression. Chi-square tests compared responder proportions using PROMIS-A/PROMIS-D symptom categories and two levels (≥5/≥7.5) of T-score point reductions. Changes across conditions over time for stress (Perceived Stress Scale), cancer-specific distress (Impact of Event Scale-Intrusions), and QoL (Functional Assessment of Cancer Therapy-General) were analyzed using repeated measures linear mixed-effects modeling (N = 449). Patient Global Impression of Change-Well-being was also examined.

Results: At Week 12, a greater proportion of CBSM (vs. control) participants reported normal-to-mild (vs. moderate-to-severe) PROMIS-A and PROMIS-D, and a greater proportion of CBSM participants at Week 8 or 12 had a ≥7.5 T-score reduction in PROMIS-A and a ≥5 T-score reduction in PROMIS-D (ps < .05). CBSM participants (vs. control) showed significantly greater reductions in Perceived Stress Scale and Impact of Event Scale-Intrusions and increases in Patient Global Impression of Change-Well-being and Functional Assessment of Cancer Therapy emotional and physical well-being (ps < .05), but not functional or social/family well-being.

Conclusion: Digitized CBSM benefits distress and QoL. (PsycInfo Database Record (c) 2024 APA, all rights reserved).