Clinical trial NCT02901834: PainSquad+: A Smartphone App to Support Real-time Pain Management for Adolescents With Cancer
Official title: PainSquad+: A Smartphone App to Support Real-time Pain Management for Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Therapy-Associated Cancer
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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research at this site, 72 ± 4% (M ± SD; range = 67-75%) of eligible AWC agreed to participate in similar studies (unpublished data).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

Eligibility 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.

Primary outcomes:
measure: Accrual and attrition rates
timeFrame: 12 months
measure: Technical difficulties
timeFrame: 12 months
measure: Acceptability
timeFrame: 12 months
measure: Adherence
timeFrame: 12 months
measure: Outcome measure feasibility
timeFrame: 12 months
measure: Pain intensity
timeFrame: 12 months
measure: Pain interference
timeFrame: 12 months
measure: Health-related quality of life (HRQL)
timeFrame: 12 months
measure: Self-efficacy
timeFrame: 12 months
measure: Healthcare utilization
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Hospital for Sick Children
name: Jennifer Stinson, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.