N/A
N=44
Cognitive Behavioral Intervention for Targeted Therapy Fatigue (CBT-TTF) Intervention
Chronic Myelogenous Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT02592447 ↗Enrolled (actual)
44
Serious AEs
—
Results posted
Mar 2019
Primary outcome: Primary: Self-reported Fatigue Scores - Change From Baseline Per Scoring Category — 28.03; 24.53; 15.7; 24.7 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Therapy for Targeted Therapy-related Fatigue (TTF) (Other); Wait-List Control Condition (WLC) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-reported Fatigue Scores - Change From Baseline Per Scoring Category |
28.03; 24.53; 15.7; 24.7 | — |
| SECONDARY Self-reported Quality of Life (QoL) Scores - Change From Baseline Per Scoring Category |
64.04; 63.83; 84.25; 68.22 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- able to speak/read English
- diagnosed with chronic phase CML
- not have been treated for other cancer (except non-melanoma skin cancer) in the past 5 years
- be under the care of a Moffitt Cancer Center (MCC) physician
- be on a stable dose of the same oral TKI for >= 3 months
- new onset or worsening of fatigue since starting TKI
- report moderate-severe fatigue in past week (FSI average rating >= 4 of 0-10)
- have no clinical history of disease (e.g., multiple sclerosis, fibromyalgia) that could account for their fatigue presentation
Exclusion Criteria
- scheduled to discontinue their TKI under medical supervision within the next 3 months
Data sourced from ClinicalTrials.gov (NCT02592447). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.