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

NCT ID: NCT02901834

Last Updated: 2018-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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research at this site, 72 ± 4% (M ± SD; range = 67-75%) of eligible AWC agreed to participate in similar studies (unpublished data).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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Therapy-Associated Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jennifer Stinson

Senior Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jennifer Stinson, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 28376666 (View on PubMed)

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.

Reference Type RESULT
PMID: 28423223 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

100045124

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pain: Screen and Treat
NCT01716780 UNKNOWN PHASE3
Characterization of Acute Pain
NCT07336264 RECRUITING