Ignite Creation Date:
2024-05-06 @ 12:22 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03747757
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2018-11-15
Brief Title:
Cognitive Behavioral Therapy in Helping Patients With Acute Myeloid Leukemia or Lymphoma With Cancer-Related Fatigue
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
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:
2024-05
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 MD Anderson Symptom Inventory - Acute Myeloid Leukemia Myelodysplastic Syndromes MDASI-AMLMDS 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-AMLMDS
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 MD Anderson Symptom Inventory - Acute Myeloid Leukemia Myelodysplastic Syndromes MDASI-AMLMDS 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-AMLMDS
OUTLINE
Patients undergo CBT consisting of 7 counseling sessions up to 45 minutes each over the phone
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2018-02528 | REGISTRY | None | None |
| 2018-0542 | OTHER | None | None |
| P30CA016672 | NIH | M D Anderson Cancer Center | httpsreporternihgovquickSearchP30CA016672 |