NCT02592447

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 29, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2018

Completed
10 months until next milestone

Results Posted

Study results publicly available

March 5, 2019

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2021

Completed
Last Updated

November 16, 2021

Status Verified

November 1, 2021

Enrollment Period

2.6 years

First QC Date

October 28, 2015

Results QC Date

December 21, 2018

Last Update Submit

November 15, 2021

Conditions

Chronic Myelogenous Leukemia

Keywords

CMLchronic phase CMLleukemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Self-reported Quality of Life (QoL) Scores - Change From Baseline Per Scoring Category

    Baseline and at 18 weeks

Study Arms (2)

Cognitive Behavior Therapy (CBT)

EXPERIMENTAL

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.

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

Wait-List Control Condition (WLC)

OTHER

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.

Other: Wait-List Control Condition (WLC)

Interventions

Therapy for Targeted Therapy-related Fatigue (TTF)OTHER

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.

Also known as: behavioral therapy
Cognitive Behavior Therapy (CBT)
Wait-List Control Condition (WLC)OTHER

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.

Also known as: standard of care, SOC
Wait-List Control Condition (WLC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • scheduled to discontinue their TKI under medical supervision within the next 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Publications (1)

  • 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.

    PMID: 34231041DERIVED

Related Links

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Myeloid, Chronic-PhaseLeukemia

Interventions

TherapeuticsBehavior TherapyStandard of Care

Condition Hierarchy (Ancestors)

Leukemia, MyeloidNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Heather Jim, PhD
Organization
H Lee Moffitt Cancer Center and Research Institute
Heather.Jim@moffitt.org
813-745-6369

Study Officials

  • Heather Jim, Ph.D.

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2015

First Posted

October 30, 2015

Study Start

September 29, 2015

Primary Completion

May 22, 2018

Study Completion

September 2, 2021

Last Updated

November 16, 2021

Results First Posted

March 5, 2019

Record last verified: 2021-11

Locations

US(1)