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

Chronic Myelogenous Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02592447
• Other study ID #: MCC-18365
• Secondary ID: R21CA191594
• Status: Completed
• Phase: N/A
• Start date: September 29, 2015
• Est. completion date: September 2, 2021

Study information

• Verified date: November 2021
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2, 2021
• Est. primary completion date: May 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Chronic Myelogenous Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

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

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Moffitt Cancer Center Clinical Trials website