Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049465
Status:
COMPLETED
Last Update Posted:
2010-09-21
First Post:
2002-11-12
Brief Title:
Standard Follow-up Compared With Extended Follow-up in Treating Patients Who Have Undergone Stem Cell Transplantation for Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FHCRC-143000 | None | None | None |
| NCI-H02-0096 | None | None | None |
| CDR0000258109 | REGISTRY | PDQ | None |