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Pain Management App for Adolescent Cancer Patients

N/A

Recruiting

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Average self-reported pain score of ≥3/10 measured using an 11-point numerical rating scale (NRS) over the preceding week

Aged 12-18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

Study Summary

This trial will study the effects of a smartphone app, called Pain Squad+, on the quality of life and healthcare costs of adolescents with cancer who experience pain. The app uses pain diaries and personalized pain advice, with or without support from a registered nurse, to give real-time pain management.

Who is the study for?

This trial is for English-speaking adolescents aged 12-18 with any type of cancer, currently on active therapy, and experiencing average pain levels of at least moderate intensity. They must have a caregiver able to engage with the study. Those with cognitive impairments or severe illnesses that affect app use or who are in other pain studies can't join.Check my eligibility

What is being tested?

The Pain Squad+ smartphone app is being tested to see if it helps teenagers manage their cancer-related pain by providing real-time advice. The study compares the effectiveness of the app alone versus the app combined with nurse support on health quality and healthcare costs.See study design

What are the potential side effects?

Since this intervention involves using an app for pain management, there may not be direct side effects like those seen with medications; however, potential indirect effects could include frustration or stress from technology use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My average pain level over the last week was 3 or higher on a scale of 0 to 10.

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I am between 12 and 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 16 weeks after baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 16 weeks after baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 16 weeks after 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

Brief Pain Inventory (BPI)

Secondary outcome measures

Health Services Use

Health Utility Index Mark 2/3 (HUI2/3)

Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Interference Short-form Scale

+2 more

Other outcome measures

Adolescent Demographic Questionnaire

Parent Demographic Questionnaire

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Experimental Group BExperimental Treatment1 Intervention

Participants in this arm will receive the Pain Squad+ smartphone app with algorithm-driven pain management advice but without nurse (RN)-initiated pain support.

Group II: Experimental Group AExperimental Treatment1 Intervention

Participants in this arm will receive the Pain Squad+ smartphone app with algorithm-driven pain management advice registered nurse (RN)-initiated pain support. Email alerts related to clinically important incoming pain reports (3 consecutive reports of pain >3/10) will be sent to the study RN who will contact the healthcare team at the participants' home center to initiate clinician-driven intervention, which may be outside of the scope of the self-management algorithm. The RN will contact the participant within 12 hours of receiving the alert, including on weekends.

Group III: Waitlist ControlActive Control1 Intervention

Participants in this arm will be waitlisted to receive their choice of experimental group condition within 1 month of completing all post-study outcome measures.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor

690 Previous Clinical Trials

6,945,256 Total Patients Enrolled

Media Library

Pain Squad+ Clinical Trial Eligibility Overview. Trial Name: NCT03632343 — N/A

Cancer Research Study Groups: Experimental Group A, Waitlist Control, Experimental Group B

Cancer Clinical Trial 2023: Pain Squad+ Highlights & Side Effects. Trial Name: NCT03632343 — N/A

Pain Squad+ 2023 Treatment Timeline for Medical Study. Trial Name: NCT03632343 — N/A

Frequently Asked Questions

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

Is this research trial open to individuals aged 70 and up?

"Individuals aged 12 to 18 who meet the criteria can join this experiment, while there are 5 other trials for minors and 140 studies available for seniors."

Answered by AI

Is this medical research still accepting participants?

"Per clinicaltrials.gov, this research project is actively enrolling patients and has been ongoing since December 1st 2019. This trial was most recently updated on June 3rd 2022."

Answered by AI

How many locations are engaged in this research endeavor?

"Nine different medical centres are providing this medication as part of the trial, such as Children's Hospital London Health Sciences in London and Alberta Children's Hospital in Calgary. Additionally, there is a selection of other sites operating across Canada."

Answered by AI

How many volunteers have enrolled in this clinical trial?

"Affirmative. According to clinicaltrials.gov, this ongoing medical research was initially posted on December 1st 2019 and last modified on June 3rd 2022. At present, 222 subjects need to be recruited from 9 distinct locations."

Answered by AI

Could I potentially qualify for participation in this medical study?

"Currently, this trial permits 222 minors aged 12-18 to receive a therapeutic procedure. Those interested should meet the following criteria: have an English-speaking and reading caregiver who is willing and able to complete outcome measures related to healthcare encounters, be proficient in both spoken and written English, possess a diagnosis of any form of cancer, require active treatment for their malignancy according to standard clinical practice guidelines, demonstrate average pain scores on an 11 point numerical rating scale over the past seven days which are greater than or equal to 3/10."

Answered by AI

Recent research and studies

BMJ OpenJournal

Pain Squad+ Smartphone App to Support Real-time Pain Treatment for Adolescents with Cancer: Protocol for a Randomised Controlled Trial

Jibb, Lindsay, Paul C Nathan, Vicky Breakey, Conrad Fernandez, Donna Johnston, Victor Lewis, Sarah McKillop, et al.. 2020. “Pain Squad+ Smartphone App to Support Real-time Pain Treatment for Adolescents with Cancer: Protocol for a Randomised Controlled Trial”. BMJ Open. BMJ. doi:10.1136/bmjopen-2020-037251.

clinicaltrials.govStudy

The Pain Squad+ Smartphone App To Support Real-Time Pain Management for Adolescents With Cancer

Jennifer Stinson 2019. "The Pain Squad+ Smartphone App To Support Real-Time Pain Management for Adolescents With Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03632343.

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