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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00782145
First received: October 29, 2008
Last updated: July 11, 2011
Last verified: July 2011

October 29, 2008
July 11, 2011
June 2008
June 2011   (final data collection date for primary 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 [ Designated as safety issue: No ]
  • Effect of HSCT-CHESS on family functioning as reported by the accompanying parent at study entry, 6, and 9 months [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Effect of HSCT-CHESS on family functioning as reported by the accompanying parent at study entry, 6, and 9 months [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00782145 on ClinicalTrials.gov Archive Site
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Supportive Care
  • Chronic Myeloproliferative Disorders
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • Neuroblastoma
  • Ovarian Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • Sarcoma
  • 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
  • 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.

    Interventions:
    • 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
  • 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).
    Interventions:
    • Other: educational intervention
    • Other: informational 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
198
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
2 Months to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00782145
CDR0000613668, R01CA119196, TUFTS-8338, WCCC-—2007-1357, CHW-07237, CHW-GC-580, DFCI-08-106, CHNMC-08009, CCHMC-0002988, FHCRC-2210
Yes
Susan Kenyon Parsons, Tufts Medical Center Cancer Center
Tufts Medical Center
National Cancer Institute (NCI)
Principal Investigator: Susan K. Parsons, MD, MRP Tufts Medical Center Cancer Center
Tufts Medical Center
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP