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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

No Placebo-Only Group

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.

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.

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

Select...

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

Select...

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brief Pain Inventory (BPI)

Secondary study objectives

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 study objectives

Adolescent Demographic Questionnaire

Parent Demographic Questionnaire

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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