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

Not Applicable

Completed

Interventions: Other: Therapy for Targeted Therapy-related Fatigue (TTF)
Other: Wait-List Control Condition (WLC)

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Cognitive Behavior Therapy (CBT)	Therapy for Targeted Therapy-related Fatigue (TTF)	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.
Wait-List Control Condition (WLC)	Wait-List Control Condition (WLC)	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.

Primary Outcome Measures

Name	Time	Method
Self-reported Fatigue Scores - Change From Baseline Per Scoring Category	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.

Secondary Outcome Measures

Name	Time	Method
Self-reported Quality of Life (QoL) Scores - Change From Baseline Per Scoring Category	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 life.