PainSquad+: A Smartphone App to Support Real-time Pain Management for Adolescents With Cancer

December 29, 2017 updated by: Jennifer Stinson, The Hospital for Sick Children

PainSquad+: A Smartphone App to Support Real-time Pain Management for Adolescents

Adolescents with cancer (AWC) are in a unique developmental stage that may mean pain characteristics, the impact of pain, and pain treatment outcomes are different in adolescents compared to children and adults. In response, we will develop and test the PainSquad+ pain management smartphone app. First, we will conduct usability testing to refine PainSquad+ so that it is useable, acceptable and understandable for AWC. Secondly we will: (a) test the feasibility of conducting a large-scale PainSquad+ experiment and (b) begin to examine how effective PainSquad+ is at helping adolescents manage pain. We hope that once developed and tested for effectiveness, PainSquad+ will improve pain treatment and ultimately quality of life in AWC.

Study Overview

Status

Completed

Conditions

Detailed Description

Using a conservative estimate of 7 adolescents per cycle and 3 testing cycles, 21 adolescents will take part in usability testing of the PainSquad+ prototype. Recruitment will be conducted in a single hematology/oncology division of a metropolitan and university-affiliated pediatric tertiary care center in Toronto, Canada. This site hosts one of the largest cancer programs in North America, with approximately 350 new diagnoses each year. Based on our previous research at this site, 72 ± 4% (M ± SD; range = 67-75%) of eligible AWC agreed to participate in similar studies (unpublished data). Convenience sampling will be used to recruit eligible individuals. The testing procedures will commence after eligibility is assessed, informed consent is obtained, and demographic and baseline outcome data are collected. Inclusion criteria will be: (a) aged 12-18 years, (b) able to speak and read English, (c) actively undergoing cancer treatment on an in- or out-patient basis, (d) being at least 3 months from diagnosis and (d) having self-reported pain of any intensity in the week immediately prior to recruitment. Exclusion criteria will be: (a) one or more major co-morbid (medical or psychiatric) conditions that would preclude use of a smartphone, and (b) palliative/end-of-life patients.

Study Type

Observational

Enrollment (Actual)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adolescents aged 12-18 years who have been diagnosed at least 2 months with cancer and have had pain in the past week.

Description

Inclusion Criteria:

  • aged 12-18 years,
  • able to speak and read English
  • actively undergoing cancer treatment on an in- or out-patient basis
  • being at least 3 months from diagnosis
  • having self-reported pain of any intensity in the week immediately prior to recruitment

Exclusion Criteria:

  • one or more major co-morbid (medical or psychiatric) conditions that would preclude use of a smartphone
  • palliative/end-of-life patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accrual and attrition rates
Time Frame: 12 months
The Cancer Pain Management App Recruitment Log has been designed to record data related to the number of eligible adolescents per recruitment day, reasons for ineligibility, and reasons for nonparticipation. The Cancer Pain Management App Activity Log has been designed to record data on attrition (occurrence/reasons for attrition), as well as technical difficulties, adherence and outcome measure completion.
12 months
Technical difficulties
Time Frame: 12 months
The occurrence and description of technical problems will be recorded on the Cancer Pain Management App Activity Log.
12 months
Acceptability
Time Frame: 12 months
The Acceptability E-Scale (AES) ascertains perceptions related to how helpful, difficult, and enjoyable e-based programs are to use, how understandable questions are, and how acceptable the time invested in reporting was (Wu, Johnson, Schepp, & Berry, 2011). For the purpose of the present study, the wording of the AES will be slightly modified. Specifically, the words "computer program" will be changed to "app" and open-ended questions regarding study acceptability will be added.
12 months
Adherence
Time Frame: 12 months
Measured as the percentage of pain reports received on the secure server. An RA will sign onto the server and extract data logged by AWC on Day 29 to calculate adherence (100% when 28/28 morning and evening reports are completed). These data will be recorded on the Cancer Pain Management App Activity Log.
12 months
Outcome measure feasibility
Time Frame: 12 months
Measured as the percentage of completed questionnaires at baseline and study completion. An RA will sign onto the server and extract data logged by AWC on Day 29 to calculate the percentage of completed questionnaires (100% when all questionnaires are completed). These data will be recorded on the Cancer Pain Management App Activity Log.
12 months
Pain intensity
Time Frame: 12 months
Measured using the pain intensity items (current pain intensity and worst, average, and least pain intensity in the previous week) of the Brief Pain Inventory (BPI). The BPI is considered the standard for clinical and research use in cancer patients (Mathias et al., 2011). Each item is rated numerically from 0-10. Individual scores on each of the 4 items may be summed and to provide a composite pain intensity score. Individual and summary scores will be used in our analyses. Validity and reliability have been well-established in adults with cancer and the intensity sub-scale has been used successfully in AWC (Ameringer, 2010).
12 months
Pain interference
Time Frame: 12 months
The Patient Reported Outcomes Measurement Information System Pediatric (PROMIS) Pain Interference Short-form Scale is an 8-item scale describing how pain restricts daily activities related to physical, psychological, and social functioning, as well as sleep, school, and enjoyment of life. Each item is scored on a 5-point Likert response scale and totaling the scores generates a summary score, which will be used in our analyses. Construct validity has been established in AWC (Hinds et al., 2013).
12 months
Health-related quality of life (HRQL)
Time Frame: 12 months
The Pediatric Quality of Life Inventory (PedsQL) 4.0 is a 23-item generic HRQL scale not specific to pain. It is comprised of physical, emotional, social and school functioning subscales with each subscale containing 5 to 8 items. PedsQL4.0 is a reliable and valid measure of HRQL in AWC (Varni, Burwinkle, Katz, Meeske, & Dickinson, 2002). We will use age-appropriate versions of PedsQL4.0 (i.e., appropriate item wording for 12 and 13-18 year olds). Total and subscale scores will be used in analyses.
12 months
Self-efficacy
Time Frame: 12 months
The Sherer's General Self-Efficacy Scale (GSES) is a 17-item scale that measures general belief in personal competence and has been used in children as young as 10 years old. Each item is scored on a 5-point Likert scale. Item scores are summed to provide an overall self-efficacy score to be used in analyses. The psychometric properties of the measure have been demonstrated in AWC (Hinds et al., 2000).
12 months
Healthcare utilization
Time Frame: 12 months
Healthcare utilization related to pain will be examined as the number of visits/calls to primary care provider, emergency room visits, oncology clinic visits and hospitalizations (i.e., bed days of care). RN calls will not be included in healthcare utilization analyses. Data will be collected using adolescent self-report and medical health records (by site specific RAs at end of study).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: Jennifer Stinson, RN, PhD, The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

September 14, 2016

First Posted (Estimate)

September 15, 2016

Study Record Updates

Last Update Posted (Actual)

January 3, 2018

Last Update Submitted That Met QC Criteria

December 29, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100045124

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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