Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Cancer Fatigue, Lymphoma, Secondary Acute Myeloid Leukemia
Conditions
Brief summary
This trial studies how well cognitive behavioral therapy works in helping patients with acute myeloid leukemia or lymphoma 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 or lymphoma cope with anxiety, depression, and other factors that may influence their level of cancer-related fatigue.
Detailed description
PRIMARY OBJECTIVES: I. To determine whether acute myeloid leukemia (AML) and lymphoma patients with cancer-related fatigue (CRF) will be satisfied with the cognitive behavioral therapy (CBT) intervention, and if CBT will be feasible for AML and lymphoma 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 and lymphoma 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, up to 45 minutes each over the phone.
Interventions
BEHAVIORALCognitive Behavior Therapy
Undergo CBT
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of AML or AML secondary to MDS (myelodysplastic syndrome) and lymphoma 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 \> 8 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 leukemia and lymphoma clinics 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to cognitive behavioral therapy (CBT) defined as percentage of the total completed prescribed counseling sessions (7 sessions) the study patient is able to complete | Up to 8 weeks or 6 months | — |
| Satisfaction with CBT assessed using a 5 point, fully word-anchored balanced bipolar scale (Satisfaction Assessment). | Up to 8 weeks | To determine if patients are satisfied with CBT, based on equal to or more than 75% of patients indicating their satisfaction with CBT with a rating of "somewhat satisfied" or "completely satisfied". Satisfaction will be assessed using a 5 point, fully word-anchored balanced bipolar scale (Satisfaction Assessment). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of symptoms determined by M.D. Anderson Symptom Inventory - Acute Myeloid Leukemia / Myelodysplastic Syndromes (MDASI-AML/MDS) | Baseline to 8 weeks or 6 months | MDASI symptom questionnaire answers range from 0 meaning "Not Present" to 10 meaning "As Bad as You Can Imagine". |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSriram Yennu
M.D. Anderson Cancer Center
Outcome results
None listed