Standard Follow-up Compared With Extended Follow-up in Treating Patients Who Have Undergone Stem Cell Transplantation for Cancer
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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 |
| Study Type: | Interventional |
| 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) |
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 |
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| 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 |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00049465 History of Changes |
| Other Study ID Numbers: | 1430.00, FHCRC-1430.00, NCI-H02-0096, CDR0000258109 |
| Study First Received: | November 12, 2002 |
| Last Updated: | September 17, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Fred Hutchinson Cancer Research Center:
|
depression fatigue menopausal symptoms transitional care planning psychosocial effects of cancer and its 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 |
Additional relevant MeSH terms:
|
Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Immunoblastic Lymphoma Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013