Standard Follow-up Compared With Extended Follow-up in Treating Patients Who Have Undergone Stem Cell Transplantation for Cancer

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00049465
• Other study ID #: 1430.00
• Secondary ID: FHCRC-1430.00NCI
• Status: Completed
• Phase: N/A
• First received: November 12, 2002
• Last updated: September 17, 2010
• Start date: August 1998

Study information

• Verified date: September 2010
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer

Intervention

Procedure:
• fatigue assessment and management

• management of therapy complications

• psychosocial assessment and care

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	AMC Cancer Research Center	Denver	Colorado
United States	Rocky Mountain Cancer Centers	Denver	Colorado
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Shands Hospital and Clinics, University of Florida	Gainesville	Florida
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Stanford University Medical Center	Stanford	California
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,