Feasibility and preliminary efficacy of a 12-week remotely delivered exercise program in patients receiving immunotherapy: A phase II randomized controlled trial.

Abstract

1638 Background: Patients with advanced cancer receiving immunotherapy experience reduced physical function, increased symptom burden, and poorer health-related quality of life (HRQOL). Limited access to structured exercise programs makes technology-supported interventions a potentially scalable alternative. We assessed the feasibility and preliminary efficacy of a 12-week remote exercise program on HRQOL, symptom burden, and fear of cancer recurrence (FCR), with an exploratory economic evaluation. Methods: In this Phase II trial, adult receiving immunotherapy alone or in combination were randomized 1:1 to a remote exercise intervention or usual care (UC). The study was powered to detect a 10-point difference in Functional Assessment of Cancer Therapy-General (FACT-G) scores (80% power, α=0.05). The intervention included weekly virtual sessions with an exercise physiologist, individualized Borg-guided exercise prescriptions, video support, and telehealth monitoring 12 weeks (30-45 minutes/day). Outcomes assessed at baseline and 12 weeks included HRQOL (FACT-G), symptom burden (Edmonton Symptom Assessment Scale; ESAS), and FCR (FCR-7). Between-group differences were analyzed using ANCOVA adjusted for baseline values, with effect sizes estimated using Cohen’s d. A preliminary provider-perspective cost-consequence analysis estimated cost per one-point FACT-G improvement. Results: Seventy patients were randomized (35 per arm); five died before 12 weeks (3 control, 2 intervention). Baseline characteristics were balanced. At 12 weeks, the intervention group had significantly higher FACT-G scores compared than UC (mean difference = 11.1; p<0.001; Cohen’s d=1.30). Symptom burden was lower in the intervention arm (p<0.001; Cohen’s d=1.68), and FCR was reduced (p=0.014; Cohen’s d=0.85). Group assignment remained a significant predictor in adjusted ANCOVA models (all p<0.01). Estimated intervention cost was R$7,023 per participant, or R$634 per FACT-G point gained. Conclusions: A 12-week remote exercise intervention produced a clinically meaningful 11-point improvement in HRQOL at an estimated cost of R$ 634 per FACT-G point, supporting its economic feasibility and scalability. The program reduced symptom burden and FCR. These findings justify larger trials to confirm effectiveness and further evaluate cost-effectiveness. Changes in patient-reported outcomes at 12 weeks. Outcome (scale) Group BaselineMean ± SD 12-weekMean ± SD Mean Change P-value Cohen’s d FACT-G Control (n=32) 87.3 ± 9.7 85.9 ± 10.2 -1.4 0.001 1.30 Intervention (n=33) 85.2 ± 9.1 96.9 ± 6.7 +11.8 ESAS Control (n=32) 17.3 ± 12.1 19.0 ± 12.8 +1.7 0.001 1.68 Intervention (n=33) 20.6 ± 9.6 5.5 ± 3.7 -15.1 FCR-7 Control (n=32) 15.0 ± 6.0 15.4 ± 6.5 +0.4 0 .014 0.85 Intervention (n=33) 16.2 ± 6.3 11.3 ± 3.8 -4.9