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

Sponsor
H. Lee Moffitt Cancer Center and Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02592447
Collaborator
National Cancer Institute (NCI) (NIH)
48
Enrollment
1
Location
2
Arms
71.1
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Therapy for Targeted Therapy-related Fatigue (TTF)
  • Other: Wait-List Control Condition (WLC)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Preliminary Evaluation of an Internet-Assisted Cognitive Behavioral Intervention for Targeted Therapy Fatigue
Actual Study Start Date :
Sep 29, 2015
Actual Primary Completion Date :
May 22, 2018
Actual Study Completion Date :
Sep 2, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: 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.

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.
Other Names:
  • behavioral therapy
  • Other: 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.

    Other: 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 Names:
  • standard of care
  • SOC
  • Outcome Measures

    Primary Outcome Measures

    1. Self-reported Fatigue Scores - Change From Baseline Per Scoring Category [Baseline and at 18 weeks]

      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

    1. Self-reported Quality of Life (QoL) Scores - Change From Baseline Per Scoring Category [Baseline and at 18 weeks]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1H. Lee Moffitt Cancer Center and Research InstituteTampaFloridaUnited States33612

    Sponsors and Collaborators

    • H. Lee Moffitt Cancer Center and Research Institute
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Heather Jim, Ph.D., H. Lee Moffitt Cancer Center and Research Institute

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    H. Lee Moffitt Cancer Center and Research Institute
    ClinicalTrials.gov Identifier:
    NCT02592447
    Other Study ID Numbers:
    • MCC-18365
    • R21CA191594
    First Posted:
    Oct 30, 2015
    Last Update Posted:
    Nov 16, 2021
    Last Verified:
    Nov 1, 2021
    Keywords provided by H. Lee Moffitt Cancer Center and Research Institute
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment DetailOf 48 consented, 4 never completed questionnaires.
    Arm/Group TitleCognitive Behavior Therapy (CBT)Wait-List Control Condition (WLC)
    Arm/Group DescriptionCognitive 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) 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.
    Period Title: Overall Study
    STARTED2915
    COMPLETED2714
    NOT COMPLETED21

    Baseline Characteristics

    Arm/Group TitleCognitive Behavior Therapy (CBT)Wait-List Control Condition (WLC)Total
    Arm/Group DescriptionCognitive 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) 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.Total of all reporting groups
    Overall Participants291544
    Age (years) [Mean (Full Range) ]
    Mean (Full Range) [years]
    53
    60
    55
    Sex: Female, Male (Count of Participants)
    Female
    14
    48.3%
    7
    46.7%
    21
    47.7%
    Male
    15
    51.7%
    8
    53.3%
    23
    52.3%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    1
    3.4%
    0
    0%
    1
    2.3%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    2
    6.9%
    3
    20%
    5
    11.4%
    White
    26
    89.7%
    12
    80%
    38
    86.4%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (Count of Participants)
    United States
    29
    100%
    15
    100%
    44
    100%

    Outcome Measures

    1. Primary Outcome
    TitleSelf-reported Fatigue Scores - Change From Baseline Per Scoring Category
    DescriptionBaseline 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 FrameBaseline and at 18 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleCognitive Behavior Therapy (CBT)Wait-List Control Condition (WLC)
    Arm/Group DescriptionCognitive 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) 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.
    Measure Participants2714
    Fatigue score at baseline
    28.03
    (6.92)
    24.53
    (7.05)
    Fatigue score at 18 weeks
    15.7
    (8.69)
    24.7
    (8.18)
    2. Secondary Outcome
    TitleSelf-reported Quality of Life (QoL) Scores - Change From Baseline Per Scoring Category
    DescriptionBaseline 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 FrameBaseline and at 18 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleCognitive Behavior Therapy (CBT)Wait-List Control Condition (WLC)
    Arm/Group DescriptionCognitive 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) 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.
    Measure Participants2714
    Quality of Life Score at Baseline
    64.04
    (15.05)
    63.83
    (14.44)
    Quality of Life Score at 18 weeks
    84.25
    (15.37)
    68.22
    (10.59)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description All Cause Mortality, Serious and Other Adverse Events were not monitored/assessed
    Arm/Group TitleCognitive Behavior Therapy (CBT)Wait-List Control Condition (WLC)
    Arm/Group DescriptionCognitive 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) 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.
    All Cause Mortality
    Cognitive Behavior Therapy (CBT)Wait-List Control Condition (WLC)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/0 (NaN) 0/0 (NaN)
    Serious Adverse Events
    Cognitive Behavior Therapy (CBT)Wait-List Control Condition (WLC)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/0 (NaN) 0/0 (NaN)
    Other (Not Including Serious) Adverse Events
    Cognitive Behavior Therapy (CBT)Wait-List Control Condition (WLC)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/0 (NaN) 0/0 (NaN)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleHeather Jim, PhD
    OrganizationH Lee Moffitt Cancer Center and Research Institute
    Phone813-745-6369
    EmailHeather.Jim@moffitt.org
    Responsible Party:
    H. Lee Moffitt Cancer Center and Research Institute
    ClinicalTrials.gov Identifier:
    NCT02592447
    Other Study ID Numbers:
    • MCC-18365
    • R21CA191594
    First Posted:
    Oct 30, 2015
    Last Update Posted:
    Nov 16, 2021
    Last Verified:
    Nov 1, 2021