Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT03747757
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-10
First Post:
2018-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Behavioral Therapy in Helping Patients With Acute Myeloid Leukemia or Lymphoma With Cancer-Related Fatigue
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Cognitive Behavioral Therapy (CBT) Intervention for Cancer Related Fatigue (CRF) in Patients With AML and Lymphoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2018-02528 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 2018-0542 | OTHER | M D Anderson Cancer Center | View | |
| P30CA016672 | NIH | None | https://reporter.nih.gov/quic… | View |