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

NCT00782145 | Completed Phase 3 DMC

• 10 other identifiers: CDR0000613668R01CA119196TUFTS-8338WCCC--2007-1357CHW-07237CHW-GC-580DFCI-08-106CHNMC-08009CCHMC-0002988FHCRC-2210
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Chronic Myeloproliferative Disorders; Leukemia; Lymphoma; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms; Neuroblastoma; Ovarian Cancer; Psychosocial Effects of Cancer and Its Treatment; Sarcoma

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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 Outcomes (2)

• 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

Study Arms (2)

Arm I

EXPERIMENTAL

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

Arm II

ACTIVE COMPARATOR

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

Interventions

educational intervention OTHER

Arm I; Arm II

informational intervention OTHER

Arm I; Arm II

internet-based intervention OTHER

Arm I

questionnaire administration OTHER

Arm I; Arm II

study of socioeconomic and demographic variables OTHER

Arm I; Arm II

survey administration OTHER

Arm I; Arm II

psychosocial assessment and care PROCEDURE

Arm I; Arm II

quality-of-life assessment PROCEDURE

Arm I; Arm II

standard follow-up care PROCEDURE

Arm I; Arm II

Eligibility Criteria

• Age: 2 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Tufts Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (6)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Myeloproliferative Disorders; Leukemia; Lymphoma; Myelodysplastic Syndromes; Myelodysplastic-Myeloproliferative Diseases; Neuroblastoma; Ovarian Neoplasms; Sarcoma; Dendritic Cell Sarcoma, Interdigitating; Burkitt Lymphoma; Recurrence; Leukemia, Myeloid, Accelerated Phase; Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative; Blast Crisis; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Chronic-Phase; Leukemia, Myelomonocytic, Juvenile; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Primary Myelofibrosis

Interventions

Early Intervention, Educational; Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Connective and Soft Tissue; Histiocytic Disorders, Malignant; Histiocytosis; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Chronic Disease; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Leukemia, Lymphoid

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Rehabilitation; Therapeutics

Study Officials

• Susan K. Parsons, MD, MRP

  Tufts Medical Center Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 29, 2008
• First Posted: October 31, 2008
• Study Start: June 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 13, 2011

Record last verified: 2011-07

Locations

US (6)