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
  Purpose

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.


Condition Intervention Phase
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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Supportive Care
Official Title: HSCT-CHESS to Enhance Hematopoietic Transplant Recovery

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 198
Study Start Date: June 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).
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

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.

  Eligibility

Ages Eligible for Study:   2 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782145

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
United States, Wisconsin
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Tufts Medical Center
Investigators
Principal Investigator: Susan K. Parsons, MD, MRP Tufts Medical Center Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Susan Kenyon Parsons, Tufts Medical Center Cancer Center
ClinicalTrials.gov Identifier: NCT00782145     History of Changes
Other Study ID Numbers: CDR0000613668, R01CA119196, TUFTS-8338, WCCC-—2007-1357, CHW-07237, CHW-GC-580, DFCI-08-106, CHNMC-08009, CCHMC-0002988, FHCRC-2210
Study First Received: October 29, 2008
Last Updated: July 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts Medical Center:
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

Additional relevant MeSH terms:
Neoplasms
Myelodysplastic Syndromes
Preleukemia
Ovarian Neoplasms
Neuroblastoma
Lymphoma
Leukemia
Syndrome
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on October 01, 2014