Trials / Completed

CompletedNCT00782145

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

HSCT-CHESS to Enhance Hematopoietic Transplant Recovery

Status: Completed
Phase: Phase 3
Study type: Interventional
Enrollment: 198 (actual)

Sponsor: Tufts Medical Center · Academic / Other
Sex: All
Age: 2 Months – 18 Years
Healthy volunteers: Not accepted

Summary

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.

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If either member of the participating dyad fails to complete all study measures\* during this time period, the dyad is withdrawn from the study.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.

Conditions

Interventions

Type	Name	Description
OTHER	educational intervention
OTHER	informational intervention
OTHER	internet-based intervention
OTHER	questionnaire administration
OTHER	study of socioeconomic and demographic variables
OTHER	survey administration
PROCEDURE	psychosocial assessment and care
PROCEDURE	quality-of-life assessment
PROCEDURE	standard follow-up care

Timeline

Start date: 2008-06-01
Primary completion: 2011-06-01
Completion: 2011-06-01
First posted: 2008-10-31
Last updated: 2011-07-13

Locations

6 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00782145. Inclusion in this directory is not an endorsement.