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Therapy-Associated CancerNCT02901834

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

An observational study of Therapy-Associated Cancer, run by The Hospital for Sick Children.

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

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. Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Therapy-Associated Cancer
How many people
40 participants
Where
No sites listed yet
Study dates
Apr 2015to May 2016
Phase
Observational
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 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

  • 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

Who cannot join

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

About this study

Official title: 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.

Read the 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.

Medical subject headings
Neoplasms, Second Primary

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accrual and attrition rates

    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.

    Measured: 12 months

  2. Technical difficulties

    The occurrence and description of technical problems will be recorded on the Cancer Pain Management App Activity Log.

    Measured: 12 months

  3. Acceptability

    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.

    Measured: 12 months

  4. Adherence

    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.

    Measured: 12 months

  5. Outcome measure feasibility

    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.

    Measured: 12 months

  6. Pain intensity

    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).

    Measured: 12 months

  7. Pain interference

    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).

    Measured: 12 months

  8. Health-related quality of life (HRQL)

    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.

    Measured: 12 months

  9. Self-efficacy

    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).

    Measured: 12 months

  10. Healthcare utilization

    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).

    Measured: 12 months

Timeline

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

  1. First posted15 Sep 2016 (estimated)
  2. Study startApr 2015
  3. Primary completionApr 2016
  4. Study completionMay 2016

Resources

More details

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

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02901834
Sponsor's protocol ID
100045124
Status last verified
Dec 2017
First submitted
12 Sep 2016
Last updated
3 Jan 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Jibb LA, Cafazzo JA, Nathan PC, Seto E, Stevens BJ, Nguyen C, Stinson JN. Development of a mHealth Real-Time Pain Self-Management App for Adolescents With Cancer: An Iterative Usability Testing Study [Formula: see text]. J Pediatr Oncol Nurs. 2017 Jul/Aug;34(4):283-294. doi: 10.1177/1043454217697022. Epub 2017 Apr 4.

    PubMed 28376666

  • Jibb LA, Stevens BJ, Nathan PC, Seto E, Cafazzo JA, Johnston DL, Hum V, Stinson JN. Implementation and preliminary effectiveness of a real-time pain management smartphone app for adolescents with cancer: A multicenter pilot clinical study. Pediatr Blood Cancer. 2017 Oct;64(10). doi: 10.1002/pbc.26554. Epub 2017 Apr 19.

    PubMed 28423223

Questions about this trial

What is this clinical trial studying?

An observational study of Therapy-Associated Cancer, run by The Hospital for Sick Children.

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

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. 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 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

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.

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.

What does the primary outcome measure?

Accrual and attrition rates (time frame: 12 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02901834, which also lists 2 linked publications.

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 3 Jan 2018.

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