Chronic Myelogenous Leukemia
Conditions
Keywords
CML, chronic phase CML, leukemia
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.
Interventions
OTHERTherapy 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.
OTHERWait-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.
Sponsors
National Cancer Institute (NCI)
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
Of 48 consented, 4 never completed questionnaires.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| 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. | 15 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Ineligible after randomization | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Cognitive Behavior Therapy (CBT) | Total | Wait-List Control Condition (WLC) |
|---|---|---|---|
| Age, Continuous | 53 years | 55 years | 60 years |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 38 Participants | 12 Participants |
| Region of Enrollment United States | 29 Participants | 44 Participants | 15 Participants |
| Sex: Female, Male Female | 14 Participants | 21 Participants | 7 Participants |
| Sex: Female, Male Male | 15 Participants | 23 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Baseline and at 18 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavior Therapy (CBT) | Self-reported Fatigue Scores - Change From Baseline Per Scoring Category | Fatigue score at baseline | 28.03 score on a scale | Standard Deviation 6.92 |
| Cognitive Behavior Therapy (CBT) | Self-reported Fatigue Scores - Change From Baseline Per Scoring Category | Fatigue score at 18 weeks | 15.7 score on a scale | Standard Deviation 8.69 |
| Wait-List Control Condition (WLC) | Self-reported Fatigue Scores - Change From Baseline Per Scoring Category | Fatigue score at baseline | 24.53 score on a scale | Standard Deviation 7.05 |
| Wait-List Control Condition (WLC) | Self-reported Fatigue Scores - Change From Baseline Per Scoring Category | Fatigue score at 18 weeks | 24.7 score on a scale | Standard Deviation 8.18 |
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.
Time frame: Baseline and at 18 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavior Therapy (CBT) | Self-reported Quality of Life (QoL) Scores - Change From Baseline Per Scoring Category | Quality of Life Score at Baseline | 64.04 score on a scale | Standard Deviation 15.05 |
| Cognitive Behavior Therapy (CBT) | Self-reported Quality of Life (QoL) Scores - Change From Baseline Per Scoring Category | Quality of Life Score at 18 weeks | 84.25 score on a scale | Standard Deviation 15.37 |
| Wait-List Control Condition (WLC) | Self-reported Quality of Life (QoL) Scores - Change From Baseline Per Scoring Category | Quality of Life Score at Baseline | 63.83 score on a scale | Standard Deviation 14.44 |
| Wait-List Control Condition (WLC) | Self-reported Quality of Life (QoL) Scores - Change From Baseline Per Scoring Category | Quality of Life Score at 18 weeks | 68.22 score on a scale | Standard Deviation 10.59 |