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

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ClinicalTrials.gov Identifier: NCT02901834
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Jennifer Stinson, The Hospital for Sick Children

Brief 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. 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.

Condition or disease
Therapy-Associated Cancer

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research at this site, 72 ± 4% (M ± SD; range = 67-75%) of eligible AWC agreed to participate in similar studies (unpublished data).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.

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: PainSquad+: A Smartphone App to Support Real-time Pain Management for Adolescents
Study Start Date : April 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

  2. Technical difficulties [ Time Frame: 12 months ]
    The occurrence and description of technical problems will be recorded on the Cancer Pain Management App Activity Log.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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).

  8. 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.

  9. 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).

  10. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901834


Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Jennifer Stinson, RN, PhD The Hospital for Sick Children