Study of @neWorld: A Virtual Community for Children With Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

October 3, 2003

Last Updated Date

November 19, 2009

Start Date ^ICMJE

April 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00070421 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Study of @neWorld: A Virtual Community for Children With Cancer

Official Title ^ICMJE

@neWorld: A Virtual Community For Kids With Cancer

Brief Summary

RATIONALE: Using an Internet Web site that enables children with cancer to interact online with classmates, participate in classroom activities, get easy-to-read medical information, and chat with family members, medical staff, and other children with cancer may help children cope with isolation, fear, and decreased self-esteem.

PURPOSE: This phase I/II trial is studying the effectiveness of an Internet Web site in providing social support and education to children who are undergoing treatment for cancer.

Detailed Description

OBJECTIVES:

Develop an Internet-based application that allows pediatric patients with cancer to enter a virtual community with the following capabilities:
- Interact with classmates and participate in classroom activities via e-mail, chat groups, online field trips, art studio, music room, and game room
- Identify and interact with a community of peers with similar medical conditions
- Access a dictionary to get medical information in understandable terms
- Interact with the medical community online
- Interact with family members online
Determine the acceptability of this program among groups of these patients and their classmates, teachers, family members, and healthcare providers using focus groups.
Determine the effect of this program on self-esteem, coping behaviors, perceived social support, cancer-relevant medical knowledge, and feelings of control over health destiny in these patients.
Determine the effect of this program on the performance of these patients in school.
Determine the effect of this program in alleviating psychological distress in these patients.

OUTLINE: This is a multicenter study.

Phase I: Students, family members, teachers, and health providers participate in focus groups to provide system design and implementation input and to assess overall acceptability of a prototype Internet-based application for pediatric cancer patients.
Phase II: Patients are assigned to 1 of 2 groups, based on participating center.
- Group 1: Patients have access to and utilize the Internet-based application @neWorld.
- Group 2: Patients do not have access to or utilize @neWorld. In both groups, patients complete questionnaires measuring psychological distress, quality of life, self-esteem, coping behaviors, perceived academic and social competence, perceived social support, cancer-relevant medical knowledge, feelings of control over health destiny, utilization of psychological services, and performance in school at baseline and 3 and 6 months.

PROJECTED ACCRUAL: A total of 94 patients (44 for group 1 and 50 for group 2) will be accrued for this study.

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other

Condition ^ICMJE

Leukemia
Lymphoma
Psychosocial Effects of Cancer and Its Treatment
Unspecified Childhood Solid Tumor, Protocol Specific

Intervention ^ICMJE

Procedure: complementary or alternative medicine procedure
Procedure: management of therapy complications
Procedure: psychosocial assessment and care

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Diagnosis of cancer
Currently receiving treatment for cancer

PATIENT CHARACTERISTICS:

Age

10 to 15

Performance status

Active

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

Able to read and speak English

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Gender

Both

Ages

10 Years to 15 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00070421

Responsible Party

Study ID Numbers ^ICMJE

CDR0000334398, LFT-NEWORLD, WCCC-2000-194

Study Sponsor ^ICMJE

Leap of Faith Technologies

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Barbara Rapchak

Leap of Faith Technologies

Information Provided By

National Cancer Institute (NCI)

Verification Date

December 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP