Cognitive Behavioral Therapy in Helping Patients With Acute Myeloid Leukemia With Cancer-Related Fatigue



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:12/5/2018
Start Date:November 29, 2018
End Date:September 11, 2020
Contact:Sriram Yennu
Email:syennu@mdanderson.org
Phone:713-792-6085

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Cognitive Behavioral Therapy (CBT) Intervention for Cancer Related Fatigue (CRF) in Patients With AML

This trial studies how well cognitive behavioral therapy works in helping patients with acute
myeloid leukemia with cancer-related fatigue. Behavioral therapy uses methods to help
patients change the way they think and act. Behavioral skills may help patients with acute
myeloid leukemia cope with anxiety, depression, and other factors that may influence their
level of cancer-related fatigue.

PRIMARY OBJECTIVES:

I. To determine whether acute myeloid leukemia (AML) patients with cancer-related fatigue
(CRF) will be satisfied with the cognitive behavioral therapy (CBT) intervention, and if CBT
will be feasible for AML patients with CRF where the feasibility will be based on adherence
measurement.

SECONDARY OBJECTIVES:

I. To examine the preliminary effects of CBT on improvement of CRF (Functional Assessment of
Cancer Illness Therapy (FACIT-F) - Fatigue subscale, its related symptoms, M.D. Anderson
Symptom Inventory - Acute Myeloid Leukemia / Myelodysplastic Syndromes (MDASI-AML/MDS),
Pittsburgh Sleep Quality Index (PSQI), Hospital Anxiety Depression Scale (HADS), and Quality
of Life (FACT-G) in AML patients receiving this combination regimen at the end of 8 weeks or
6 months.

EXPLORATORY OBJECTIVES:

I. To explore the effects of CBT on hope for future and burdens of treatment and their
interference with patients' lives using the Herth Hope Index (HHI), and MDASI-AML/MDS.

OUTLINE:

Patients undergo CBT consisting of 7 counseling sessions over the phone.

Inclusion Criteria:

- Diagnosis of newly diagnosed AML (diagnosis of AML in prior 3 months) or AML secondary
to MDS (myelodysplastic syndrome) with fatigue >= 4/10 (0-10 scale) on the
MDASI-AML/MDS.

- Presence of fatigue for at least 2 weeks.

- Normal cognition by Memorial Delirium Assessment Scale score of < 13 at baseline.

- Hemoglobin > 10 g/L within 2 weeks of enrollment in the study; if the patient has not
had blood drawn for a hemoglobin level in the past two weeks, one will be done to
determine the eligibility.

- Zubrod performance status =< 2.

- Able to communicate in English or Spanish.

- Seen at a leukemia clinic at University of Texas (UT) MD Anderson Cancer Center,
Houston, Texas and its affiliates in University of Texas.

Exclusion Criteria:

- Has received CBT (cognitive behavioral therapy) for any indication (e.g. depression,
sleep disturbance) in the past 1 year.

- Inability to comply with study protocol procedures.

- Prior cancer diagnosis other than noted in the inclusion criterion #1.
We found this trial at
1
site
Houston, Texas 77030
Principal Investigator: Sriram Yennu
Phone: 713-792-6085
?
mi
from
Houston, TX
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