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

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Chronic Myelogenous Leukemia

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02592447

MCC-18365

R21CA191594 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Cognitive Behavior Therapy (CBT)

Experimental group

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.

Treatment:

Other: Therapy for Targeted Therapy-related Fatigue (TTF)

Wait-List Control Condition (WLC)

Other group

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.

Treatment:

Other: Wait-List Control Condition (WLC)