Standard Follow-up Compared With Extended Follow-up in Tr... | NCT00049465 | Trialant
NCT00049465
Sponsor
Fred Hutchinson Cancer Center
Status
Completed
Last Update Posted
Sep 21, 2010Estimated
Enrollment
Not provided
Phase
Not Applicable
Conditions
Cancer
Interventions
fatigue assessment and management
management of therapy complications
psychosocial assessment and care
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00049465
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1430.00
Secondary IDs
ID
Type
Description
Link
FHCRC-1430.00
NCI-H02-0096
CDR0000258109
Registry Identifier
PDQ
Brief Title
Standard Follow-up Compared With Extended Follow-up in Treating Patients Who Have Undergone Stem Cell Transplantation for Cancer
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
Acronym
Not provided
Organization
Fred Hutchinson Cancer CenterOTHER
Status Module
Record Verification Date
Sep 2010
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 1998
Primary Completion Date
Feb 2005Actual
Completion Date
Not provided
First Submitted Date
Nov 12, 2002
First Submission Date that Met QC Criteria
Jan 26, 2003
First Posted Date
Jan 27, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 17, 2010
Last Update Posted Date
Sep 21, 2010Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Fred Hutchinson Cancer CenterOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
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.
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.
Conditions Module
Conditions
Cancer
Keywords
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
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not Applicable
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
Not provided
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
fatigue assessment and management
Procedure
management of therapy complications
Procedure
psychosocial assessment and care
Procedure
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility 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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Karen Syrjala, MD
Fred Hutchinson Cancer Center
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Stanford University Medical Center
Stanford
California
94305-5623
United States
AMC Cancer Research Center
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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