- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00782145
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.
Study Overview
Status
Conditions
Intervention / Treatment
- Other: survey administration
- Other: questionnaire administration
- Procedure: psychosocial assessment and care
- Procedure: quality-of-life assessment
- Other: educational intervention
- Other: study of socioeconomic and demographic variables
- Other: internet-based intervention
- Procedure: standard follow-up care
- Other: informational intervention
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 If either member of the participating dyad fails to complete all study measures* during this time period, the dyad is withdrawn from the study.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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
California
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Duarte, California, United States, 91010-3000
- City of Hope Comprehensive Cancer Center
-
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Massachusetts
-
Boston, Massachusetts, United States, 02115
- Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
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Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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Washington
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Seattle, Washington, United States, 98109-1024
- Fred Hutchinson Cancer Research Center
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
|
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).
|
What is the study measuring?
Primary Outcome Measures
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
|
Effect of HSCT-CHESS on family functioning as reported by the accompanying parent at study entry, 6, and 9 months
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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
|
Secondary Outcome Measures
Outcome Measure |
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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
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Susan K. Parsons, MD, MRP, Tufts Medical Center Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- primary myelofibrosis
- recurrent childhood small noncleaved cell lymphoma
- recurrent childhood large cell lymphoma
- chronic myelomonocytic leukemia
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- secondary acute myeloid leukemia
- childhood acute lymphoblastic leukemia in remission
- childhood acute myeloid leukemia in remission
- juvenile myelomonocytic leukemia
- chronic phase chronic myelogenous leukemia
- childhood chronic myelogenous leukemia
- childhood myelodysplastic syndromes
- recurrent/refractory childhood Hodgkin lymphoma
- blastic phase chronic myelogenous leukemia
- relapsing chronic myelogenous leukemia
- psychosocial effects of cancer and its treatment
- previously treated childhood rhabdomyosarcoma
- recurrent childhood rhabdomyosarcoma
- disseminated neuroblastoma
- recurrent neuroblastoma
- recurrent childhood acute lymphoblastic leukemia
- accelerated phase chronic myelogenous leukemia
- recurrent ovarian germ cell tumor
- recurrent childhood acute myeloid leukemia
- myelodysplastic/myeloproliferative neoplasm, unclassifiable
- atypical chronic myeloid leukemia, BCR-ABL negative
- recurrent childhood lymphoblastic lymphoma
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms, Glandular and Epithelial
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Precancerous Conditions
- Neuroectodermal Tumors, Primitive
- Neuroectodermal Tumors, Primitive, Peripheral
- Lymphoma
- Syndrome
- Myelodysplastic Syndromes
- Leukemia
- Preleukemia
- Neuroblastoma
- Myeloproliferative Disorders
- Myelodysplastic-Myeloproliferative Diseases
Other Study ID Numbers
- CDR0000613668
- R01CA119196 (U.S. NIH Grant/Contract)
- TUFTS-8338
- WCCC--2007-1357
- CHW-07237
- CHW-GC-580
- DFCI-08-106
- CHNMC-08009
- CCHMC-0002988
- FHCRC-2210
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