Cognitive Behavioral Therapy (CBT) Intervention for Cancer Related Fatigue (CRF) in Patients With AML and Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 =<
- •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.
排除标准
- •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.
研究组 & 干预措施
Supportive Care (CBT)
Patients undergo CBT consisting of 7 counseling sessions, up to 45 minutes each over the phone.
干预措施: Cognitive Behavior Therapy (Behavioral)
Supportive Care (CBT)
Patients undergo CBT consisting of 7 counseling sessions, up to 45 minutes each over the phone.
干预措施: Quality-of-Life Assessment (Other)
Supportive Care (CBT)
Patients undergo CBT consisting of 7 counseling sessions, up to 45 minutes each over the phone.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
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
时间窗: Up to 8 weeks or 6 months
Satisfaction with CBT assessed using a 5 point, fully word-anchored balanced bipolar scale (Satisfaction Assessment).
时间窗: 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).
次要结局
- 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)