A Web-Based Stem Cell Transplant Support System or Standard Care in Young Patients Undergoing Stem Cell Transplant and Their Families

July 11, 2011 updated by: Tufts Medical Center

HSCT-CHESS to Enhance Hematopoietic Transplant Recovery

RATIONALE: A Web site for stem cell transplant health information and support may be effective in helping parents improve their health-related knowledge, skills, and quality of life, which may also improve their children's quality of life.

PURPOSE: This randomized phase III trial is studying a Web-based stem cell transplant support system to see how well it works compared with standard care in families of young patients undergoing a stem cell transplant.

Study Overview

Detailed Description

OBJECTIVES:

Primary

  • To evaluate the ability of a Web-based Hematopoietic Stem Cell Transplantation (HSCT-) Comprehensive Health Enhancement Support System (HSCT-CHESS) to mitigate the impact of a child's HSCT on the health-related quality of life, family functioning, knowledge, skills, and processes of care of the accompanying parent.

Secondary

  • To explore the potential mechanisms of action of HSCT-CHESS in improving outcomes in these parents, in terms of parental activation, social support and/or coping skills.
  • To explore the impact of HSCT-CHESS on the health-related quality of life of the pediatric HSCT patient, as reported by the parent and child.

OUTLINE: This is a multicenter study. Pediatric hematopoietic stem cell transplantation (HSCT) recipients (ages 2 months-18 years) and accompanying parents are asked to complete a baseline assessment battery by the start of transplant conditioning (the 'run-in' period). If either member of the participating dyad fails to complete all study measures* during this time period, the dyad is withdrawn from the study. The dyads are randomized into 1 of 2 intervention arms.

NOTE: *Measures will not be collected from pediatric patients under 5 years of age at baseline or follow-up.

  • Arm I: Each dyad receives institution-specific usual care for 6 months, which typically includes psychosocial support for the HSCT recipient and individualized or group education and support for the accompanying parent during the peri-transplant period. They also receive the Web-based Hematopoietic Stem Cell Transplantation (HSCT-) Comprehensive Health Enhancement Support System (HSCT-CHESS) intervention for 6 months. Accompanying parents also may identify a companion to receive access to the HSCT-CHESS Web site.

The HSCT-CHESS Web site provides ready access to accurate information and resources about pediatric HSCT, practical tips, organizational tools, and other supportive services for use during the transplant process. While the Web site is designed primarily for use by the accompanying parent, it also includes some resources for child and adolescent HSCT recipients that the parent may choose to share. In addition to collecting data for later analysis, the Web site tracking system allows for further tailoring of information and support for the user, principally by time post transplant.

  • Arm II: Each dyad receives institution-specific usual care for 6 months as described in arm I. Accompanying parents also receive a book from the Blood and Marrow Transplant Information Network (BMT InfoNet).

Each dyad completes quality-of-life assessment (Child Health Ratings Inventory [CHRIs]-General and CHRIs-HSCT) at day 45, and at 3, 6, 9, and 12 months and CHRIS-General at baseline. The accompanying parent provides demographic information at baseline and 6 months and completes Patient Health Questionnaire (PHQ-9) for depression screening at baseline and 6 and 9 months. The accompanying parent also completes other measures for family and individual coping, social support, process of care, and Internet use at baseline and 6 and 9 months.

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope Comprehensive Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
    • Washington
      • Seattle, Washington, United States, 98109-1024
        • Fred Hutchinson Cancer Research Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Disease indications for hematopoietic stem cell transplantation (HSCT)

    • All transplant types allowed
  • Scheduled to receive HSCT within the next 30 days

PATIENT CHARACTERISTICS:

  • Dyad consisting of age-eligible child and parent
  • Child patient with an "accompanying parent" who consents to participate

    • "Accompanying parent" is defined as the parent/legal guardian who physically stays with the recipient during the initial HSCT hospitalization and plans to be present during the follow-up assessments

      • If the responsibility for care giving is shared, parents will designate who will participate (i.e., as study participant)

        • No substitutions are permitted once this decision has been made
    • Accompanying parent must be ≥ 18 years old
  • Possesses a working knowledge of English
  • Able to sign consent/assent to participate

PRIOR CONCURRENT THERAPY:

  • No concurrent participation in another quality-of-life intervention study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I

Each dyad receives institution-specific care for 6 months, which typically includes psychosocial support for the HSCT recipient and individualized or group education and support for the accompanying parent during the peri-transplant period. They also receive the Web-based Hematopoietic Stem Cell Transplantation (HSCT-) Comprehensive Health Enhancement Support System (HSCT-CHESS) intervention for 6 months. Accompanying parents also identify a companion to receive access to the HSCT-CHESS Web Site.

The HSCT-CHESS Web site provides ready access to accurate information and resources about pediatric HSCT, practical tips, organizational tools, and other supporting services for use during the transplant process. In addition to collecting data for later analysis, the Web site tracking system allows for further tailoring of information and support for the user, principally by time post transplant.

Active Comparator: Arm II
Each dyad receives institution-specific usual care for 6 months as described in arm I. Accompanying parents also receive a book from the Blood and Marrow Transplant Information Network (BMT Infonet).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Effect of the Hematopoietic Stem Cell Transplantation Comprehensive Health Enhancement Support System (HSCT-CHESS) on health-related quality of life of the accompanying parent at study entry, day 45 and 3, 6, 9, and 12 months
Effect of HSCT-CHESS on family functioning as reported by the accompanying parent at study entry, 6, and 9 months
Effect of HSCT-CHESS on accompanying parent's knowledge and skills in caring for self and the HSCT recipient, increased confidence interacting with health care provider(s) and greater healthcare participation at study entry, 6, and 9 months

Secondary Outcome Measures

Outcome Measure
Potential mechanisms of action of HSCT-CHESS in improving parental activation, social support and/or coping skills at study entry and 6 and 9 months
Health-related quality of life of the patient as reported by both parent and child at study entry, day 45, 3, 6, 9, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Susan K. Parsons, MD, MRP, Tufts Medical Center Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

October 29, 2008

First Submitted That Met QC Criteria

October 29, 2008

First Posted (Estimate)

October 31, 2008

Study Record Updates

Last Update Posted (Estimate)

July 13, 2011

Last Update Submitted That Met QC Criteria

July 11, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • CDR0000613668
  • R01CA119196 (U.S. NIH Grant/Contract)
  • TUFTS-8338
  • WCCC--2007-1357
  • CHW-07237
  • CHW-GC-580
  • DFCI-08-106
  • CHNMC-08009
  • CCHMC-0002988
  • FHCRC-2210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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