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

Lymphoma Clinical Trial

Official title:

HSCT-CHESS to Enhance Hematopoietic Transplant Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00782145
• Other study ID #: CDR0000613668
• Secondary ID: R01CA119196TUFTS
• Status: Completed
• Phase: Phase 3
• First received: October 29, 2008
• Last updated: July 11, 2011
• Start date: June 2008
• Est. completion date: June 2011

Study information

• Verified date: July 2011
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 If either member of the participating dyad fails to complete all study measures* during this time period, the dyad is withdrawn from the study.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 18 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Myeloproliferative Disorders
• Leukemia
• Lymphoma
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasms
• Myeloproliferative Disorders
• Neuroblastoma
• Ovarian Cancer
• Preleukemia
• Psychosocial Effects of Cancer and Its Treatment
• Sarcoma

Intervention

Other:
• educational intervention

• informational intervention

• internet-based intervention

• questionnaire administration

• study of socioeconomic and demographic variables

• survey administration

Procedure:
• psychosocial assessment and care

• quality-of-life assessment

• standard follow-up care

Locations

Country	Name	City	State
United States	Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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			No
Primary	Effect of HSCT-CHESS on family functioning as reported by the accompanying parent at study entry, 6, and 9 months			No
Primary	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			No
Secondary	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			No
Secondary	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			No