Cognitive Behavioral Intervention for Targeted Therapy Fatigue (CBT-TTF) Intervention
NCT ID: NCT02592447
Last Updated: 2021-11-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2015-09-29
2021-09-02
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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)
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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Principal Investigators
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Heather Jim, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
H. Lee Moffitt Cancer Center and Research Institute
Locations
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H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Countries
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References
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Oswald LB, Hyland KA, Eisel SL, Hoogland AI, Knoop H, Nelson AM, Pinilla-Ibarz J, Sweet K, Jacobsen PB, Jim HSL. Correlates of fatigue severity in patients with chronic myeloid leukemia treated with targeted therapy. Support Care Cancer. 2022 Jan;30(1):87-94. doi: 10.1007/s00520-021-06408-1. Epub 2021 Jul 7.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MCC-18365
Identifier Type: -
Identifier Source: org_study_id