NCT03747757

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
16mo left

Started Nov 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Nov 2018Sep 2027

First Submitted

Initial submission to the registry

November 15, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

November 29, 2018

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2027

Last Updated

November 10, 2025

Status Verified

November 1, 2025

Enrollment Period

8.8 years

First QC Date

November 15, 2018

Last Update Submit

November 7, 2025

Conditions

Acute Myeloid LeukemiaAcute Myeloid Leukemia Arising From Previous Myelodysplastic SyndromeCancer FatigueLymphomaSecondary Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

  • 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).

    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 Outcomes (1)

  • 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

Study Arms (1)

Supportive Care (CBT)

EXPERIMENTAL

Patients undergo CBT consisting of 7 counseling sessions, up to 45 minutes each over the phone.

Behavioral: Cognitive Behavior TherapyOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

Cognitive Behavior TherapyBEHAVIORAL

Undergo CBT

Also known as: CBT, cognitive therapy, CT
Supportive Care (CBT)
Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment
Supportive Care (CBT)
Questionnaire AdministrationOTHER

Ancillary studies

Supportive Care (CBT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Yennurajalingam 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: 36384181DERIVED

Related Links

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteLymphoma

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sriram Yennu

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2018

First Posted

November 20, 2018

Study Start

November 29, 2018

Primary Completion (Estimated)

September 11, 2027

Study Completion (Estimated)

September 11, 2027

Last Updated

November 10, 2025

Record last verified: 2025-11

Locations

US(1)