Cognitive Behavioral Intervention for Targeted Therapy Fatigue (CBT-TTF) Intervention

Study Overview
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Brief Summary
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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.

Official Title
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Preliminary Evaluation of an Internet-Assisted Cognitive Behavioral Intervention for Targeted Therapy Fatigue

Conditions
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Chronic Myelogenous Leukemia

Intervention / Treatment
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* Other: Therapy for Targeted Therapy-related Fatigue (TTF)
* Other: Wait-List Control Condition (WLC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavior Therapy (CBT)<br>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. | Other: Therapy for Targeted Therapy-related Fatigue (TTF)<br>* Cognitive Behavior Therapy for Targeted Therapy-related Fatigue (CBT-TTF) group will receive cognitive behavior therapy 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. The sessions will initially be held weekly, but the therapist may schedule sessions at 1-, 2-, or 3-week intervals during the 18 week study period. The final session will be conducted either in-person at Moffitt or via FaceTime.<br>* Other names: behavioral therapy;|
| Other: Wait-List Control Condition (WLC)<br>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. | Other: Wait-List Control Condition (WLC)<br>* Participants randomized to Wait-List Control Condition will continue to receive care under direction of their Moffitt Cancer Center (MCC) physician. Physicians will be informed by email of patients' participation on the basis of elevated fatigue and their randomization to WLC. Chart review and a patient self-report form will be used at baseline and follow-up assessments to determine what, if any, services or interventions participants received in the preceding 18 weeks that might address fatigue.<br>* Other names: SOC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported Fatigue Scores - Change From Baseline Per Scoring Category | 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. | Baseline and at 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported Quality of Life (QoL) Scores - Change From Baseline Per Scoring Category | 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 life. | Baseline and at 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CML, chronic phase CML, leukemia