Depression Clinical Trial
Official title:
In-Hospital Individualized Prescriptive Exercise Intervention for Acute Leukemia Patients Undergoing Chemotherapy
RATIONALE: An individualized exercise program may be effective in lessening fatigue and
depression and improving quality of life in patients undergoing chemotherapy for leukemia.
PURPOSE: This clinical trial is studying how well individualized exercise programs work in
patients receiving chemotherapy for newly diagnosed acute or relapsed myeloid leukemia or
lymphoblastic leukemia.
Status | Completed |
Enrollment | 10 |
Est. completion date | August 2009 |
Est. primary completion date | January 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Newly diagnosed acute or relapsed myeloid or lymphoblastic leukemia - Currently receiving re-induction therapy or designated for chemotherapy treatment - Expected hospital stay of 3-4 weeks or longer - Participation in the study must be approved by the physician directly responsible for the patient's care while at University of North Carolina Hospitals PATIENT CHARACTERISTICS: - No condition that would compromise the patient's ability to participate in the exercise rehabilitation program, including any of the following: - Immune deficiency - Acute or chronic bone, joint, or muscular abnormalities - Acute or chronic respiratory disease - Cardiovascular disease PRIOR CONCURRENT THERAPY: - See Disease Characteristics |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
UNC Lineberger Comprehensive Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effects of an individualized prescriptive exercise intervention | All patients will participate in an individualized prescriptive exercise intervention 3 to 4 times per week (depending on the physical status of each patient during each week) for a period of 6 weeks. The exercise intervention will begin on week 1 of the study, the day after the first battery of initial assessments is concluded. Each exercise session will be divided into two bouts. One bout will be administered in the morning and the second one late in the afternoon | 6 weeks | No |
Secondary | Number of subjects experiencing fatigue, depression, and quality of life issues | The Functional Assessment of Cancer Therapy-General (FACT-G) will be administered to assess the levels of fatigue, and quality of life on weeks 2, 3 and 5 of the 6 week trial. The Center for Epidemiologic Studies Depression Scale (CES-D) will be also administered to explore the effects of exercise on depression on weeks 2, 3 and 5 of the 6 week trial. | 6 weeks | No |
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