Clinical trial · Interventional
Cognitive Behavioral Therapy in Helping Patients With Acute Myeloid Leukemia or Lymphoma With Cancer-Related Fatigue
Cognitive Behavioral Therapy (CBT) Intervention for Cancer Related Fatigue (CRF) in Patients With AML and Lymphoma
NCT03747757CI-TRIAL-00112192active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome | Acute Myeloid Leukemia Arising from Previous Myelodysplastic Syndrome | ONTOLOGY_EXACT | 0.98 |
| Cancer Fatigue | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Secondary Acute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Behavior Therapy | Behavioral | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive Care (CBT)
- description
- Patients undergo CBT consisting of 7 counseling sessions, up to 45 minutes each over the phone.
- interventionNames
- Behavioral: Cognitive Behavior Therapy
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (2)
- measure
- 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
- timeFrame
- Up to 8 weeks or 6 months
- measure
- Satisfaction with CBT assessed using a 5 point, fully word-anchored balanced bipolar scale (Satisfaction Assessment).
- timeFrame
- Up to 8 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDYennurajalingam S, Konopleva M, Carmack CL, Dinardo CD, Gaffney M, Michener HK, Lu Z, Stanton P, Ning J, Qiao W, Bruera E. Treatment of Cancer-related-Fatigue in Acute Hematological Malignancies: Results of a Feasibility Study of using Cognitive Behavioral Therapy. J Pain Symptom Manage. 2023 Mar;65(3):e189-e197. doi: 10.1016/j.jpainsymman.2022.11.003. Epub 2022 Nov 13. PMID 36384181