H. Lee Moffitt Cancer Center and Research Institute
Who can join
18 and older, any sex, with Chronic Myelogenous Leukemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Self-reported Fatigue Scores - Change From Baseline Per Scoring CategoryPrimary· Baseline and at 18 weeks
Baseline versus follow-up fatigue will be assessed with the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue) v.4, a 13-item self-report measure yielding total score with demonstrated reliability, validity, sensitivity to change and an identified Minimally Clinically Important Difference (MID). The fatigue subscale consists of 13 items asking about fatigue in the past 7 days. Items are summed to produce a score ranging from 0-52 with lower scores indicating greater fatigue. A difference of 3 points on the fatigue subscale indicates a clinically-important difference
Fatigue score at baseline
Group
Value
95% CI
Cognitive Behavior Therapy (CBT)
28.03
± 6.92
Wait-List Control Condition (WLC)
24.53
± 7.05
Fatigue score at 18 weeks
Group
Value
95% CI
Cognitive Behavior Therapy (CBT)
15.7
± 8.69
Wait-List Control Condition (WLC)
24.7
± 8.18
Self-reported Quality of Life (QoL) Scores - Change From Baseline Per Scoring CategorySecondary· Baseline and at 18 weeks
Baseline versus follow-up quality of life will be assessed with the Functional Assessment of Cancer Therapy General Scale (FACT-G) v.4, a 27-item measure yielding total score and scores for physical, social/family, emotional, and functional well-being of demonstrated reliability, validity, and sensitivity to change. FACT-G consists of 4 subscales: physical well-being (PWB), functional well-being (FWB), emotional well-being (EWB) and social well-being (SWB). Scores on the four subscales are summed to produce a total score ranging from 0 to 108 with higher scores indicating better quality of lif
Quality of Life Score at Baseline
Group
Value
95% CI
Cognitive Behavior Therapy (CBT)
64.04
± 15.05
Wait-List Control Condition (WLC)
63.83
± 14.44
Quality of Life Score at 18 weeks
Group
Value
95% CI
Cognitive Behavior Therapy (CBT)
84.25
± 15.37
Wait-List Control Condition (WLC)
68.22
± 10.59
Sponsor's own description
The purpose of this study is to evaluate Cognitive Behavioral Intervention for Targeted Therapy Fatigue (CBT-TTF) with fatigued chronic myelogenous leukemia (CML) patients on tyrosine kinase inhibitors (TKIs) for feasibility, acceptability and potential efficacy relative to usual care only in a small-scale randomized controlled trial.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute
Last refreshed: 16 November 2021
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