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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03747757
Collaborator
National Cancer Institute (NCI) (NIH)
48
1
1
45.4
1.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive Behavior Therapy
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
Phase 2

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:
  1. 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:
  1. 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 Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Cognitive Behavioral Therapy (CBT) Intervention for Cancer Related Fatigue (CRF) in Patients With AML and Lymphoma
Actual Study Start Date :
Nov 29, 2018
Anticipated Primary Completion Date :
Sep 11, 2022
Anticipated Study Completion Date :
Sep 11, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Supportive Care (CBT)

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

Behavioral: Cognitive Behavior Therapy
Undergo CBT
Other Names:
  • CBT
  • cognitive therapy
  • CT
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    2. 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

    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]

      MDASI symptom questionnaire answers range from 0 meaning "Not Present" to 10 meaning "As Bad as You Can Imagine".

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Sriram Yennu, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT03747757
    Other Study ID Numbers:
    • 2018-0542
    • NCI-2018-02528
    • 2018-0542
    • P30CA016672
    First Posted:
    Nov 20, 2018
    Last Update Posted:
    Jan 28, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 28, 2022