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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Therapy for Targeted Therapy-related Fatigue (TTF)

Wait-List Control Condition (WLC)

About this trial

This is an interventional supportive care trial for Chronic Myelogenous Leukemia focused on measuring CML, chronic phase CML, leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

H. Lee Moffitt Cancer Center and Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Cognitive Behavior Therapy (CBT)

Wait-List Control Condition (WLC)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02592447

First Posted

October 28, 2015

Last Updated

November 15, 2021

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT02592447

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

September 29, 2015 (Actual)

Primary Completion Date

May 22, 2018 (Actual)

Study Completion Date

September 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Myelogenous Leukemia

Keywords

CML, chronic phase CML, leukemia

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cognitive Behavior Therapy (CBT)

Arm Type

Experimental

Arm 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.

Arm Title

Wait-List Control Condition (WLC)

Arm Type

Other

Arm 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.

Intervention Type

Other

Intervention Name(s)

Therapy for Targeted Therapy-related Fatigue (TTF)

Other Intervention Name(s)

behavioral therapy

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Wait-List Control Condition (WLC)

Other Intervention Name(s)

standard of care, SOC

Intervention Description

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.

Primary Outcome Measure Information:

Title

Self-reported Fatigue Scores - Change From Baseline Per Scoring Category

Description

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.

Time Frame

Baseline and at 18 weeks

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Baseline and at 18 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heather Jim, Ph.D.

Organizational Affiliation

H. Lee Moffitt Cancer Center and Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

H. Lee Moffitt Cancer Center and Research Institute

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

34231041

Citation

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.

Results Reference

derived

Links:

URL

https://www.moffitt.org/clinical-trials-research/

Description

Moffitt Cancer Center Clinical Trials website

Chronic Myelogenous Leukemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial