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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03747757
• Other study ID #: 2018-0542
• Secondary ID: NCI-2018-0252820
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 29, 2018
• Est. completion date: September 11, 2025

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: September 11, 2025
• Est. primary completion date: September 11, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
• Cancer Fatigue
• Fatigue
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Lymphoma
• Myelodysplastic Syndromes
• Secondary Acute Myeloid Leukemia

Intervention

Behavioral:
• Cognitive Behavior Therapy
Undergo CBT

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Satisfaction with CBT assessed using a 5 point, fully word-anchored balanced bipolar scale (Satisfaction Assessment).	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).	Up to 8 weeks
Secondary	Improvement of symptoms determined by M.D. Anderson Symptom Inventory - Acute Myeloid Leukemia / Myelodysplastic Syndromes (MDASI-AML/MDS)	MDASI symptom questionnaire answers range from 0 meaning "Not Present" to 10 meaning "As Bad as You Can Imagine".	Baseline to 8 weeks or 6 months

External Links

•   MD Anderson Cancer Center Website