Quality of Life of Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Longitudinal Assessment of Neurocognitive Function and Quality of Life of Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS) Undergoing Treatment
Primary Objectives:
- To compare the neuropsychiatric (NP) and neurocognitive (NC) symptoms and assess the quality of life (QOL) in older patients (age > 18) with acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (MDS) receiving different therapies, chemotherapy (Clofarabine + ara-C) or targeted therapies (PKC412 + low-dose ara-C, or R115777 + low-dose ara-C, or decitabine, or STI + low-dose ara-C).
- To determine whether there is a correlation between the number of packed red blood cell (PRBC) transfusions and cognitive scores and/or QOL.
연구 개요
상세 설명
You will participate in a series of neurocognitive tests. For these tests, you will be asked to complete certain tasks that require the use of your hands, eyes, and ears. The neurocognitive testing will take about 30 minutes.
You will answer some questionnaires about disease symptoms and your quality of life. It will take about 30 minutes to complete the questionnaires.
You will participate in these neurocognitive tests and fill out the questionnaires before you begin cancer therapy. Your interval testing will coincide with your clinic visit evaluations, which will be approximately at 1 month, 3 months, and 6 months. If you do not receive therapy, you will be asked to complete the neurocognitive tests at baseline and then again on your follow up clinic visit evaluations, which will be approximately at 3 months and at 6 months. You may be asked to continue your participation in these neurocognitive tests and fill out questionnaires approximately every 3 months thereafter.
This is an investigational study. About 306 patients will take part in this study. All will be enrolled at UTMDACC.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Texas
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Houston, Texas, 미국, 77030
- U.T.M.D. Anderson Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients with newly diagnosed AML or MDS. Patients who fail an MDS/AML therapy and receive other therapies may be asked to continue participation in this neurocognitive study.
- Patients who are 18 years of age or older.
- Patients who are seen in the MDACC adult Leukemia clinic. Patients who do not enroll onto therapy protocols are also eligible.
- Patients must sign the informed consent.
Exclusion Criteria:
1) Not applicable
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Questionnaire
AML and MDS Patients
|
Questionnaires taking about 30 minutes to complete.
다른 이름들:
Neurocognitive testing lasting 30 minutes.
Patients will be asked to complete certain tasks that require the use of their hands, eyes, and ears.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Effect of cancer therapy on AML or MDS patients (longitudinal assessment neuropsychiatric (NP), neurocognitive (NC) symptoms, quality of life (QOL))
기간: Interval testing will be approximately at 1 month, 3 months, and 6 months.
|
Interval testing will be approximately at 1 month, 3 months, and 6 months.
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Effects of therapy on the ability to think, quality of life, the ability to perform everyday tasks, and how often side effects occur.
기간: 6 Years
|
6 Years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Christina A. Meyers, PhD, M.D. Anderson Cancer Center
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .