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Standard Follow-up Compared With Extended Follow-up in Treating Patients Who Have Undergone Stem Cell Transplantation for Cancer

This study is ongoing, but not recruiting participants.

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   

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   August 1998

Detailed Description:

OBJECTIVES:

  • Compare the recovery course of patients with malignancies who undergo standard vs extended recovery preparation after hematopoietic stem cell transplantation.
  • Compare the efficacy of these recovery preparations in managing rehabilitation needs, including reduced stamina and cognitive limitations, of these patients.
  • Compare the ability of these recovery preparations to assist patients and caregivers in adjusting to unavoidable fluctuations in caregiver roles and emotions.
  • Compare the ability of these recovery preparations to assist female patients in managing menopausal symptoms and sexual function changes.

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.

  • Arm I (Standard Recovery Preparation): Patients and caregivers receive standard preparation prior to discharge, a booklet of stem cell transplant-related resources and contact information, and the National Cancer Institute-produced publication entitled "Facing Forward".
  • Arm II (Recovery Preparation Intervention): Patients and caregivers receive standard preparation and resource materials as in arm I. Women also receive 10 scheduled telephone appointment sessions, lasting 1 hour each, over the first year after returning home. Men receive 9 scheduled telephone appointment sessions in the same manner as the women. The first 5-6 sessions have a specific topic with a corresponding video. The last 4 calls are booster calls to answer questions, identify new problems, and provide support. Patients with acute problems or problems that cannot be handled through regular sessions are referred to the interdisciplinary recovery triage team. Problems addressed by this team include depression, agitation, cognitive change, fatigue, family disruptions, sexuality, and gynecologic or menopausal difficulties.

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

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of a malignancy
  • Planned bone marrow, stem cell, or umbilical cord transplantation after a myeloablative conditioning regimen

    • Must have completed radiotherapy and conditioning chemotherapy
    • Must be first stem cell transplantation
    • Must recover sufficiently, physically and cognitively, to be ambulatory and able to live at home
  • Must be planning to live with primary caregiver for at least 3 months upon return home
  • No refractory breast cancer requiring treatment on a phase I protocol

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Must be able to read, write, and communicate well by phone in English
  • Must not be deaf or blind
  • Must live in the United States
  • Must not be too ill or in too much pain
  • No major psychiatric disorders not in remission
  • No prisoners
  • No prior major alcohol or drug abuse
  • No major cognitive problems
  • No other concurrent confounding major illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics

Surgery

  • Not specified
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049465

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

Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Karen Syrjala, MD     Fred Hutchinson Cancer Research Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000258109, FHCRC-1430.00, NCI-H02-0096
First Received:   November 12, 2002
Last Updated:   November 16, 2008
ClinicalTrials.gov Identifier:   NCT00049465
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
depression  
fatigue  
menopausal symptoms  
transitional care planning  
psychosocial effects/treatment  
accelerated phase chronic myelogenous leukemia  
chronic idiopathic myelofibrosis  
blastic phase chronic myelogenous leukemia  
chronic phase chronic myelogenous leukemia  
de novo myelodysplastic syndromes  
disseminated neuroblastoma  
meningeal chronic myelogenous leukemia  
noncontiguous stage II adult diffuse large cell lymphoma  
noncontiguous stage II adult diffuse mixed cell lymphoma  
noncontiguous stage II adult diffuse small cleaved cell lymphoma  
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
noncontiguous stage II mantle cell lymphoma
ovarian choriocarcinoma
ovarian embryonal carcinoma
ovarian yolk sac tumor
ovarian immature teratoma
ovarian mature teratoma
ovarian monodermal and highly specialized teratoma
ovarian polyembryoma
ovarian mixed germ cell tumor

Study placed in the following topic categories:
Blast Crisis
Sezary syndrome
Chronic myelogenous leukemia
Hodgkin lymphoma, adult
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Seminoma
Ovarian epithelial cancer
Lymphoma, large-cell, immunoblastic
Mycoses
Preleukemia
Multiple myeloma
Neoplasm Metastasis
Acute myeloid leukemia, adult
Hodgkin Disease
Chronic lymphocytic leukemia
Myelodysplastic syndromes
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Depression
Leukemia, B-cell, chronic
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Acute myelogenous leukemia
Myeloproliferative Disorders
Breast Neoplasms
Leukemia, Myeloid
Testicular Neoplasms
Depressive Disorder
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on November 20, 2008




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