Internet-assisted cognitive behavioral intervention for targeted therapy–related fatigue in chronic myeloid leukemia: Results from a pilot randomized trial
Mené sur 44 patients atteints d'une leucémie myéloïde chronique (âge moyen : 55 ans, 48 % de femmes), cet essai randomisé évalue l'efficacité, du point de vue de la réduction de la fatigue liée aux thérapies ciblées et de l'amélioration de la qualité de vie, d'une intervention de psychothérapie comportementale dispensée sur internet
Background : Fatigue is a common and disabling side effect of targeted therapies such as tyrosine kinase inhibitors (TKIs) used to treat chronic myeloid leukemia (CML). The goal of the current study was to conduct a pilot randomized trial of the first cognitive behavioral intervention developed for fatigue due to targeted therapy. Methods : Patients with CML treated with a TKI who were reporting moderate to severe fatigue were recruited and randomized 2:1 to cognitive behavioral therapy for targeted therapy–related fatigue (CBT-TTF) delivered via FaceTime for the iPad or to a waitlist control (WLC) group. The outcomes were acceptability, feasibility, and preliminary efficacy for fatigue (Functional Assessment of Chronic Illness Therapy–Fatigue; primary outcome) and quality of life (Functional Assessment of Cancer Therapy–General; secondary outcome). Participants were assessed before randomization and after treatment (ie, approximately 18 weeks later). Results : A total of 44 patients (mean age, 55 years; 48% female) were assigned to CBT-TTF (n = 29) or WLC (n = 15). The study participation rate was 59%. Among the patients assigned to CBT-TTF, 79% completed the intervention. Intent-to-treat analyses indicated that patients assigned to CBT-TTF demonstrated greater improvements in fatigue (d = 1.06; P < .001) and overall quality of life (d = 1.15; P = .005) than those assigned to WLC. More patients randomized to CBT-TTF than WLC demonstrated clinically significant improvements in fatigue (85% vs 29%) and quality of life (88% vs 54%; P values ≤ .016). Conclusions : CBT-TTF displays preliminary efficacy in improving fatigue and quality of life among fatigued patients with CML treated with TKIs. The findings suggest that a larger randomized study is warranted.