Standard Follow-up Compared With Extended Follow-up in Treating Patients Who Have Undergone Stem Cell Transplantation for Cancer
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.
|Cancer||Procedure: fatigue assessment and management Procedure: management of therapy complications Procedure: psychosocial assessment and care|
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|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|
|Primary Completion Date:||February 2005 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049465
|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|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0914|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|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|
|Study Chair:||Karen Syrjala, MD||Fred Hutchinson Cancer Research Center|