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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00070421
Other study ID # LFT-NEWORLD
Secondary ID CDR0000334398WCC
Status Completed
Phase Phase 1/Phase 2
First received October 3, 2003
Last updated May 14, 2013
Start date April 2003
Est. completion date January 2005

Study information

Verified date December 2004
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date January 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 15 Years
Eligibility 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

Study Design

N/A


Related Conditions & MeSH terms

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

Intervention

Procedure:
complementary or alternative medicine procedure

management of therapy complications

psychosocial assessment and care


Locations

Country Name City State
United States Leap of Faith Technologies, Incorporated Crystal Lake Illinois

Sponsors (2)

Lead Sponsor Collaborator
Leap of Faith Technologies National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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