Clinical trial · Interventional

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

NCT00782145CI-TRIAL-00005203completedPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (9)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Chronic Myeloproliferative Disorders	Myeloproliferative Neoplasm	ALIAS	0.90
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90
Lymphoma	Lymphoma	ONTOLOGY_EXACT	0.90
Myelodysplastic/Myeloproliferative Neoplasms	Myelodysplastic/Myeloproliferative Neoplasm	CURATED_BROADER	0.80
Myelodysplastic Syndromes	Myelodysplastic Syndrome	ALIAS	0.90
Neuroblastoma	Neuroblastoma	ONTOLOGY_EXACT	0.90
Ovarian Cancer	Malignant Ovarian Neoplasm	CURATED_EXACT	0.92
Psychosocial Effects of Cancer and Its Treatment	—	UNRESOLVED	—
Sarcoma	Sarcoma	ONTOLOGY_EXACT

Interventions

Interventions (9)

Intervention	Type	Mapped drug	Match
educational intervention	Other	—	UNRESOLVED
informational intervention	Other	—	UNRESOLVED
internet-based intervention	Other	—	UNRESOLVED
psychosocial assessment and care	Procedure	—	UNRESOLVED
quality-of-life assessment	Procedure	—	UNRESOLVED
questionnaire administration	Other	—	UNRESOLVED
standard follow-up care	Procedure	—	UNRESOLVED
study of socioeconomic and demographic variables	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Arm I
description
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.
interventionNames
1. Other: educational intervention
2. Other: informational intervention
3. Other: internet-based intervention
4. Other: questionnaire administration
5. Other: study of socioeconomic and demographic variables
6. Other: survey administration
7. Procedure: psychosocial assessment and care
8. Procedure: quality-of-life assessment
9. Procedure: standard follow-up care
type

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 2 Months
Maximum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Jun 1, 2008
Primary completion: Jun 1, 2011
Completion: Jun 1, 2011
First posted: Oct 31, 2008
Last update posted: Jul 13, 2011
Enrollment: 198 (actual)
Lead sponsor: Tufts Medical Center OTHER
Collaborators: National Cancer Institute (NCI)
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