A Web-Based Stem Cell Transplant Support System or Standard Care in Young Patients Undergoing Stem Cell Transplant and Their Families
Condition: Chronic Myeloproliferative Disorders; Leukemia; Lymphoma; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms; Neuroblastoma; Ovarian Cancer; Psychosocial Effects of Cancer and Its Treatment; Sarcoma
MeSH terms: Lymphoma; Leukemia; Preleukemia; Neuroblastoma; Myelodysplastic Syndromes; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Syndrome
Study type: Interventional
Phase: Phase 3

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      time period, the dyad is withdrawn from the study.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.
    

Intervention name(s): educational intervention; informational intervention; internet-based intervention; questionnaire administration; study of socioeconomic and demographic variables; survey administration; psychosocial assessment and care; quality-of-life assessment; standard follow-up care
Intervention type(s): Other; Other; Other; Other; Other; Other; Procedure; Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Supportive Care
Keywords: psychosocial effects of cancer and its treatment; recurrent childhood large cell lymphoma; recurrent childhood lymphoblastic lymphoma; recurrent childhood small noncleaved cell lymphoma; recurrent/refractory childhood Hodgkin lymphoma; accelerated phase chronic myelogenous leukemia; atypical chronic myeloid leukemia, BCR-ABL negative; blastic phase chronic myelogenous leukemia; childhood acute lymphoblastic leukemia in remission; childhood acute myeloid leukemia in remission; childhood chronic myelogenous leukemia; chronic myelomonocytic leukemia; chronic phase chronic myelogenous leukemia; juvenile myelomonocytic leukemia; recurrent childhood acute lymphoblastic leukemia; recurrent childhood acute myeloid leukemia; relapsing chronic myelogenous leukemia; secondary acute myeloid leukemia; childhood myelodysplastic syndromes; primary myelofibrosis; de novo myelodysplastic syndromes; disseminated neuroblastoma; myelodysplastic/myeloproliferative neoplasm, unclassifiable; previously treated childhood rhabdomyosarcoma; previously treated myelodysplastic syndromes; recurrent childhood rhabdomyosarcoma; recurrent neuroblastoma; recurrent ovarian germ cell tumor; secondary myelodysplastic syndromes