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

September 17, 2010 updated by: Fred Hutchinson Cancer Center

Multi-Site Randomized Clinical Trial Comparing Standard Recovery Preparation to Extended Recovery Preparation to Enhance Long Term Function After Marrow or Stem Cell Transplant

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305-5623
        • Stanford University Medical Center
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers
      • Denver, Colorado, United States, 80214
        • AMC Cancer Research Center
    • Florida
      • Gainesville, Florida, United States, 32610-100277
        • Shands Hospital and Clinics, University of Florida
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0914
        • University of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, United States, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157-1082
        • Comprehensive Cancer Center at Wake Forest University
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Huntsman Cancer Institute
    • Washington
      • Seattle, Washington, United States, 98109-1024
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Karen Syrjala, MD, Fred Hutchinson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1998

Primary Completion (Actual)

February 1, 2005

Study Registration Dates

First Submitted

November 12, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

September 21, 2010

Last Update Submitted That Met QC Criteria

September 17, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1430.00
  • FHCRC-1430.00
  • NCI-H02-0096
  • CDR0000258109 (Registry Identifier: PDQ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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