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| Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00049465 |
Purpose
RATIONALE: Telephone counseling by trained counselors may enhance the well-being and quality of life of patients who have undergone stem cell transplantation for cancer.
PURPOSE: Randomized clinical trial to compare the effectiveness of standard follow-up care with extended follow-up care in treating patients who have undergone stem cell transplantation for cancer.
| Condition | Intervention |
|
Cancer |
Procedure: fatigue assessment and management Procedure: management of therapy complications Procedure: psychosocial assessment and care |
| Genetics Home Reference related topics: | breast cancer |
| MedlinePlus related topics: | Breast Cancer Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Active Control |
| Official Title: | Multi-Site Randomized Clinical Trial Comparing Standard Recovery Preparation to Extended Recovery Preparation to Enhance Long Term Function After Marrow or Stem Cell Transplant |
| Study Start Date: | August 1998 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to gender, type of transplantation (allogeneic vs autologous), ethnicity (Caucasian vs non-Caucasian), total body irradiation (yes vs no), and participating center. Patients are randomized to 1 of 2 supportive care arms.
Patients complete 1 baseline assessment prior to transplant and a second assessment after the transplant, approximately 1 week before returning home.
Patients are followed at 1 and 2 years.
PROJECTED ACCRUAL: A total of 412 patients and their caregivers (385 patients randomized) will be accrued for this study within 4 years.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Planned bone marrow, stem cell, or umbilical cord transplantation after a myeloablative conditioning regimen
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| United States, California | |||||
| Stanford University Medical Center | |||||
| Stanford, California, United States, 94305-5623 | |||||
| United States, Colorado | |||||
| AMC Cancer Research Center | |||||
| Denver, Colorado, United States, 80214 | |||||
| Rocky Mountain Cancer Centers | |||||
| Denver, Colorado, United States, 80218 | |||||
| United States, Florida | |||||
| Shands Hospital and Clinics, University of Florida | |||||
| Gainesville, Florida, United States, 32610-100277 | |||||
| United States, Michigan | |||||
| Barbara Ann Karmanos Cancer Institute | |||||
| Detroit, Michigan, United States, 48201-1379 | |||||
| University of Michigan Comprehensive Cancer Center | |||||
| Ann Arbor, Michigan, United States, 48109-0914 | |||||
| United States, North Carolina | |||||
| Comprehensive Cancer Center at Wake Forest University | |||||
| Winston-Salem, North Carolina, United States, 27157-1082 | |||||
| United States, Utah | |||||
| Huntsman Cancer Institute | |||||
| Salt Lake City, Utah, United States, 84132 | |||||
| United States, Washington | |||||
| Fred Hutchinson Cancer Research Center | |||||
| Seattle, Washington, United States, 98109-1024 | |||||
| Fred Hutchinson Cancer Research Center |
| National Cancer Institute (NCI) |
| Study Chair: | Karen Syrjala, MD | Fred Hutchinson Cancer Research Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000258109, FHCRC-1430.00, NCI-H02-0096 |
| First Received: | November 12, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00049465 |
| Health Authority: | United States: Federal Government |
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