Preliminary Evaluation of an Internet-Assisted Cognitive Behavioral Intervention for Targeted Therapy Fatigue
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Self-reported Fatigue Scores - Change From Baseline Per Scoring Category
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Cognitive Behavior Therapy (CBT)
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.
Intervention: Therapy for Targeted Therapy-related Fatigue (TTF) (Other)
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.
Intervention: Wait-List Control Condition (WLC) (Other)
Outcomes
Primary Outcomes
Self-reported Fatigue Scores - Change From Baseline Per Scoring Category
Time Frame: 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 Outcomes
- Self-reported Quality of Life (QoL) Scores - Change From Baseline Per Scoring Category(Baseline and at 18 weeks)