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

Phase 2

Active, not recruiting

• Conditions: Cancer Fatigue; Acute Myeloid Leukemia; Lymphoma; Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome; Secondary Acute Myeloid Leukemia
• Interventions: Behavioral: Cognitive Behavior Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT03747757
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study First Submitted: 2018-11-15
• Study First Submitted QC: 2018-11-19
• Study First Posted: 2018-11-20
• Study Start: 2018-11-29
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13
• Primary Completion: 2025-09-11
• Study Completion: 2025-09-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive Care (CBT)	Questionnaire Administration	Patients undergo CBT consisting of 7 counseling sessions, up to 45 minutes each over the phone.
Supportive Care (CBT)	Quality-of-Life Assessment	Patients undergo CBT consisting of 7 counseling sessions, up to 45 minutes each over the phone.
Supportive Care (CBT)	Cognitive Behavior Therapy	Patients undergo CBT consisting of 7 counseling sessions, up to 45 minutes each over the phone.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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".

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States