AzTrials
AzTrials

LeukemiaPhase 1/2NCT00070421

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

A Phase 1/2 study testing complementary or alternative medicine procedure, management of therapy complications and psychosocial assessment and care in people with Leukemia and Lymphoma, run by Leap of Faith Technologies at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 10 to 15 years
What is being tested?
complementary or alternative medicine procedure, management of therapy complications and psychosocial assessment and care
Type of treatment
Surgery or procedure
How many people
Not given
Where
1 siteUnited States
Study dates
Apr 2003to Jan 2005
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Leap of Faith Technologies, Incorporated

    Crystal Lake, Illinois, 60014

Other trials in United States

About this study

Official title: @neWorld: A Virtual Community For Kids With Cancer

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.

Read the 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.

Being tested
complementary or alternative medicine procedure, management of therapy complications, psychosocial assessment and care
Keywords
psychosocial effects of cancer and its treatment, unspecified childhood solid tumor, protocol specific, childhood acute lymphoblastic leukemia in remission, childhood acute myeloid leukemia in remission, recurrent childhood acute lymphoblastic leukemia, recurrent childhood acute myeloid leukemia, recurrent childhood large cell lymphoma, recurrent childhood lymphoblastic lymphoma, recurrent childhood small noncleaved cell lymphoma, stage I childhood Hodgkin lymphoma, stage I childhood large cell lymphoma, stage I childhood lymphoblastic lymphoma, stage I childhood small noncleaved cell lymphoma, stage II childhood Hodgkin lymphoma, stage II childhood large cell lymphoma, stage II childhood lymphoblastic lymphoma, stage II childhood small noncleaved cell lymphoma, stage III childhood Hodgkin lymphoma, stage III childhood large cell lymphoma, stage III childhood lymphoblastic lymphoma
Medical subject headings
Leukemia, Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Dendritic Cell Sarcoma, Interdigitating, Burkitt Lymphoma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • complementary or alternative medicine procedureProcedure or surgery

  • management of therapy complicationsProcedure or surgery

  • psychosocial assessment and careProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2003 (estimated)
  2. Study startApr 2003
  3. Study completionJan 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
IDs, dates and publications
ClinicalTrials.gov ID
NCT00070421
Sponsor's protocol ID
LFT-NEWORLD
Other IDs
CDR0000334398, WCCC-2000-194
Status last verified
Dec 2004
First submitted
3 Oct 2003
Last updated
15 May 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing complementary or alternative medicine procedure, management of therapy complications and psychosocial assessment and care in people with Leukemia and Lymphoma, run by Leap of Faith Technologies at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00070421.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2013.

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