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

This study is no longer recruiting patients.

Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention
Cancer
Depression
Fatigue
menopausal symptoms
psychosocial effects and treatment
transitional care planning
 Procedure: complications of therapy assessment/management
 Procedure: fatigue assessment/management
 Procedure: psychosocial assessment/care
 Procedure: supportive care/therapy

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Depression;   Reproductive Health

Study Type: Interventional
Study Design: Treatment

Official Title: Randomized Study of Standard Versus Extended Recovery Preparation After Hematopoietic Stem Cell Transplantation in Patients With Malignancies

Further Study Details: 

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 above,  Genders Eligible for Study:  Both

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

Location Information


California
      Stanford University Medical Center, Stanford,  California,  94305-5623,  United States

Colorado
      AMC Cancer Research Center, Denver,  Colorado,  80214,  United States

      Rocky Mountain Cancer Centers, Denver,  Colorado,  80218,  United States

Florida
      Shands Hospital and Clinics, University of Florida, Gainesville,  Florida,  32610-100277,  United States

Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201-1379,  United States

      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0914,  United States

North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States

Utah
      Huntsman Cancer Institute, Salt Lake City,  Utah,  84132,  United States

Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109-1024,  United States

Study chairs or principal investigators

Karen Syrjala, MD,  Study Chair,  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
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  November 12, 2002
ClinicalTrials.gov Identifier:  NCT00049465
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005