Multi-Site Randomized Clinical Trial Comparing Standard Recovery Preparation to Extended Recovery Preparation to Enhance Long Term Function After Marrow or Stem Cell Transplant
- 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
- 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.
Allocation: Randomized, Primary Purpose: Supportive Care
Karen Syrjala, MD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Stanford University Medical Center||Stanford, California 94305-5408|
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|Shands Hospital and Clinics, University of Florida||Gainesville, Florida 32610-100277|
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|
|Huntsman Cancer Institute||Salt Lake City, Utah 84112|
|Rocky Mountain Cancer Centers||Thornton, Colorado 80260|
|AMC Cancer Research center||Denver, Colorado 80214|