Clinical trial · Interventional
Cognitive Behavioral Intervention for Targeted Therapy Fatigue (CBT-TTF) Intervention
Preliminary Evaluation of an Internet-Assisted Cognitive Behavioral Intervention for Targeted Therapy Fatigue
NCT02592447CI-TRIAL-00055047completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Therapy for Targeted Therapy-related Fatigue (TTF) | Other | — | UNRESOLVED |
| Wait-List Control Condition (WLC) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cognitive Behavior Therapy (CBT)
- description
- Cognitive Behavior Therapy for Targeted Therapy-related Fatigue (CBT-TTF) to help manage fatigue via FaceTime on an iPad, which will be provided to participants. Participants will meet with a trained therapist who will outline their therapy plan and will be taught how to use the iPad for upcoming therapy sessions.
- interventionNames
- Other: Therapy for Targeted Therapy-related Fatigue (TTF)
- type
- OTHER
- label
- Wait-List Control Condition (WLC)
- description
- Wait-List Control Condition (WLC) group will not receive therapy sessions and will continue usual care with their providers. This group will be offered the same cognitive behavior therapy as the group receiving the CBT-TTF intervention, after the 18 week study period.
- interventionNames
- Other: Wait-List Control Condition (WLC)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDOswald LB, Hyland KA, Eisel SL, Hoogland AI, Knoop H, Nelson AM, Pinilla-Ibarz J, Sweet K, Jacobsen PB, Jim HSL. Correlates of fatigue severity in patients with chronic myeloid leukemia treated with targeted therapy. Support Care Cancer. 2022 Jan;30(1):87-94. doi: 10.1007/s00520-021-06408-1. Epub 2021 Jul 7. PMID 34231041