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Pain Buddy App for Childhood Cancer

N/A
Recruiting
Led By Michelle A Fortier, Ph.D.
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between the ages of 8-18 years
Currently undergoing outpatient treatment for cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 60, and day 180
Awards & highlights

Study Summary

This trial is testing a mobile app called Pain Buddy to see if it can help document a child's pain, symptoms, and quality of life while receiving outpatient chemotherapy. The goal is to use the data to develop a way to improve quality of life for children with cancer.

Who is the study for?
This trial is for children aged 8-18 with cancer, undergoing outpatient treatment. They must be able to speak, read, and write in English (or their parents in English/Spanish), have home internet access for Pain Buddy use. Children with AML or APL or cognitive impairments are excluded.Check my eligibility
What is being tested?
Pain Buddy is being tested to see if it can help monitor pain and improve quality of life for children receiving chemotherapy at home. It's a mobile health tech tool that tracks daily pain and symptoms to aid in managing treatments effectively.See study design
What are the potential side effects?
Since Pain Buddy is a monitoring tool rather than a medication, there aren't traditional side effects associated with its use; however, user satisfaction and any stress related to using the technology will be assessed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 8 and 18 years old.
Select...
I am receiving cancer treatment without staying in the hospital.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Children's Anxiety and Depression assessed using the Revised Child Anxiety and Depression Scale (RCADS)
Changes in Perceived Stress (parent self-report)
Changes in children's quality of life since using Pain Buddy is assessed using the Pediatric Quality of Life Inventory (child self-report, ages 8-12, 13-18; parent report child ages 8-12, 13-18)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pain BuddyExperimental Treatment1 Intervention
Children in this condition will continue with the care that has been prescribed for cancer- and chemotherapy-related pain and symptoms, which may include medications, medical visits, physical interventions, etc. Participants in this condition will complete daily diaries using Pain Buddy and will also be taught cognitive and behavioral coping skills, like deep breathing, imagery, and relaxation, to deal with pain and symptoms. The skills will be taught through the electronic tablet. Pain and symptom information, collected daily by Pain Buddy, will be sent to a health care provider on the oncology treatment team, who will contact patients when certain thresholds are reached and will instruct the patients on best ways to control pain and symptoms.
Group II: ControlActive Control1 Intervention
Children in this condition will continue with the care that has been prescribed for cancer- and chemotherapy-related pain and symptoms, which may include medications, medical visits, physical interventions, etc. Participants in this condition will complete daily pain diaries using Pain Buddy, but will not receive skills training or remote monitoring of data.

Find a Location

Who is running the clinical trial?

American Cancer Society, Inc.OTHER
224 Previous Clinical Trials
110,355 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,268 Total Patients Enrolled
University of California, IrvineLead Sponsor
543 Previous Clinical Trials
1,922,901 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are taking part in this clinical trial?

"Indeed, clinicaltrials.gov has information that suggests this is a live medical trial. It was initially posted on August 1st 2019 and recently updated on November 9th 2022; with the intention of recruiting 100 patients from one location."

Answered by AI

Are there opportunities for individuals to participate in the experiment at this time?

"Affirmative. Clinicaltrials.gov reveals that this clinical trial is still open to recruitment, with the first posting having been on August 1st 2019. As of November 9th 2022, 100 participants are being sought from one single medical facility."

Answered by AI

Are applicants age 35 and over eligible for this experiment?

"Prospective participants in this trial must be aged ranging from 8 to 18. Notably, there are 62 studies involving minors and a further 432 trials for seniors over 65."

Answered by AI

Am I eligible for participation in this scientific investigation?

"To meet the inclusion criteria for this study, participants must suffer from cancer and be within 8 to 18 years old. The trial seeks to recruit a total of 100 individuals."

Answered by AI
~3 spots leftby Jun 2024