Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-02-28 @ 7:10 PM
Study NCT ID:
NCT02901834
Status:
COMPLETED
Last Update Posted:
2018-01-03
First Post:
2016-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PainSquad+: A Smartphone App to Support Real-time Pain Management for Adolescents With Cancer
Sponsor:
The Hospital for Sick Children
Organization:
Study Overview
Official Title:
PainSquad+: A Smartphone App to Support Real-time Pain Management for Adolescents
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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research at this site, 72 ± 4% (M ± SD; range = 67-75%) of eligible AWC agreed to participate in similar studies (unpublished data).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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: