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The Pain Squad+ Smartphone App To Support Real-Time Pain Management for Adolescents With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03632343
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Jennifer Stinson, The Hospital for Sick Children

Brief Summary:
Pain negatively affects the quality of life of adolescents with cancer (AWC). It can also represent a high cost to the healthcare system and families. In response, our team has built a smartphone-based app, called Pain Squad+, which can give AWC real-time advice to manage their pain. The app uses pain diaries and personalized pain advice plus support from a registered nurse to give real-time pain management in all settings. This study will look at the impact of Pain Squad+, with or without the nurse support, on AWC health quality and healthcare costs over time.

Condition or disease Intervention/treatment Phase
Therapy-Associated Cancer Other: Pain Squad+ with Nurse Support Other: Pain Squad+ Not Applicable

Detailed Description:
Pain negatively affects the quality of life (QOL) of adolescents with cancer (AWC), slows cancer recovery, and results in negative long-term health effects. Pain is also significant cost to the healthcare system and families. To address this problem, the study investigators have developed and used a phased-approach to test a smartphone-based app, called Pain Squad+. Using this app AWC report the pain they have and the app provides AWC with advice on how to treat this pain based on an algorithm our team developed. An email is also sent to a nurse if an AWC reports severe pain 3 times in a row. The nurse then contacts the AWC to assist in treating pain. This project will test the effect of the Pain Squad+ app, with and without nurse help, on treating pain and other pain-related health issues and managing costs associated with pain care, when compared to AWC not using the app. Investigators will enroll 222 AWC recruited from 9 Canadian pediatric oncology care centres into a 3-group randomized controlled trial. AWC in the experimental groups will be asked to use Pain Squad+ for 8 weeks (with or without nurse involvement) and all groups will complete pain-related outcome measures at baseline, 2-, 4-, 8-, and 16-weeks. The primary study outcome will be pain intensity. The secondary study outcomes will be (a) pain interference; (b) QOL; (c) pain self-efficacy; and (d) cost effectiveness and utility. Investigators will use established statistical methods to analyze the health and cost data collected over the course of this study. A real-time and cost effective way to address the problem of pain in AWC is needed. Pain Squad+ can improve pain treatment and QOL for AWC as well as decrease costs incurred by families and the healthcare system. If effective, the Pain Squad+ as a model of technology-assisted care may represent a way to improve the QOL for a range of Canadian patients by treating a variety of physical and psychological symptoms the moment they occur.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This will be a multi-centre, waitlist group controlled, data analyst blinded, 3-arm parallel-group superiority randomized controlled trial (RCT) with 1:1:1 allocation. Randomization will be stratified by recruitment site to account for differences in care across sites49 with block sizes of 6 and 9 within each stratum. This trial has been designed along the pragmatic end of the pragmatic-explanatory continuum. Our approach to study eligibility criteria, intervention intensity, and participant adherence will determine intervention effect under real-world conditions.
Masking: Double (Participant, Care Provider)
Primary Purpose: Health Services Research
Official Title: The Pain Squad+ Smartphone App To Support Real-Time Pain Management for Adolescents With Cancer: A Randomized Controlled Trial
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Group A
Participants in this arm will receive the Pain Squad+ smartphone app with algorithm-driven pain management advice registered nurse (RN)-initiated pain support. Email alerts related to clinically important incoming pain reports (3 consecutive reports of pain >3/10) will be sent to the study RN who will contact the healthcare team at the participants' home center to initiate clinician-driven intervention, which may be outside of the scope of the self-management algorithm. The RN will contact the participant within 12 hours of receiving the alert, including on weekends.
Other: Pain Squad+ with Nurse Support
Pain Squad+ smartphone app with algorithm-driven pain management advice registered nurse (RN)-initiated pain support. Email alerts related to clinically important incoming pain reports (3 consecutive reports of pain >3/10) will be sent to the study RN who will contact the healthcare team at the participants' home center to initiate clinician-driven intervention, which may be outside of the scope of the self-management algorithm. The RN will contact the participant within 12 hours of receiving the alert, including on weekends.

Experimental: Experimental Group B
Participants in this arm will receive the Pain Squad+ smartphone app with algorithm-driven pain management advice but without nurse (RN)-initiated pain support.
Other: Pain Squad+
Pain Squad+ smartphone app with algorithm-driven pain management advice without RN-initiated pain support.

No Intervention: Waitlist Control
Participants in this arm will be waitlisted to receive their choice of experimental group condition within 1 month of completing all post-study outcome measures.



Primary Outcome Measures :
  1. Brief Pain Inventory (BPI) [ Time Frame: Change from baseline Brief Pain Inventory measure at 4 time points: 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 16 weeks after baseline ]
    The BPI assesses current pain and 'worst', 'least', and 'average' pain in the preceding week using an 11-point numerical rating scale (NRS) with verbal anchors 'no pain' at 0 and 'pain as bad as you can imagine' at 10. Item scores are averaged to give a Pain Intensity Summary Score.


Secondary Outcome Measures :
  1. Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Interference Short-form Scale [ Time Frame: Baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 16 weeks after baseline ]
    The PROMIS instrument is a valid 8- item scale assessing the impact of pain on function. Higher scores represent greater interference with function. We will use the established Bonferroni correction to account for serial comparisons.

  2. Pediatric Quality of Life Inventory (PedsQL) 4.0 [ Time Frame: Baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 16 weeks after baseline ]
    The PedsQL 4.0 is a valid and reliable 23-item instrument not specific to pain. It is comprised of 4 subscales (physical functioning, emotional functioning, social functioning and school functioning), which are summed to provide a total score. Higher scores represent better QOL. We will separately analyze the subscales and total scale scores of the PedsQL.

  3. Porter's scale [ Time Frame: Baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 16 weeks after baseline ]
    Porter's scale which assesses self-efficacy for managing pain, symptoms, and function in cancer patients. This 16-item scale includes a valid and reliable 5-item subscale assessing cancer pain management self-efficacy with higher scores indicating more certainty and is adapted from a scale that has been successfully administered to adolescents.

  4. Health Utility Index Mark 2/3 (HUI2/3) [ Time Frame: Baseline, 8 weeks after baseline, 16 weeks after baseline ]
    Quality-adjusted life years (QALYs)68 will be calculated using data from the valid and reliable HUI2/3.

  5. Health Services Use [ Time Frame: Baseline, 8 weeks after baseline, 16 weeks after baseline ]
    Direct healthcare costs will include the intervention and costs for health service use by AWC during the trial. Family out-of-pocket expenses, indirect costs due to lost productivity, and health service use will be ascertained using standardized customized data collection forms.


Other Outcome Measures:
  1. Adolescent Demographic Questionnaire [ Time Frame: Baseline ]
    This questionnaire will ask about socio-economic, demographic, and disease information for descriptive purposes. It will also obtain information on potential moderators of observed treatment effects: AWC age, sex, ethnicity, school grade, diagnosis, stage/risk, relapse-status, treatment-type, date of diagnosis, co-morbid conditions and medications, and pain history.

  2. Parent Demographic Questionnaire [ Time Frame: Baseline ]
    This questionnaire will ask about parents about their age, sex, ethnicity, educational attainment, and financial characteristics



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • aged 12-18 years,
  • are able to speak and read English,
  • are diagnosed with cancer (all disease types),
  • are on active therapy,
  • have an average self-reported pain score of ≥3/10 measured using an 11-point numerical rating scale (NRS) over the preceding week, and
  • have an English-speaking and reading caregiver who is willing and able to complete outcome measures related to healthcare encounters

Exclusion Criteria:

  • with significant cognitive impairments or co-morbid illnesses (as determined by their medical team) that would limit interaction with Pain Squad+ or outcome measure assessment,
  • who are currently participating in other pain management studies, and
  • who are not expected to survive past 16 weeks as determined by their oncologist

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): NCT03632343


Contacts
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Contact: Jennifer Stinson, PhD 4168137654 ext 304514 jennifer.stinson@sickkids.ca
Contact: Cynthia Nguyen, MPH 4168137654 ext 302332 cynthia.nguyen@sickkids.ca

Locations
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Canada, Alberta
Alberta Children's Hospital Not yet recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Victor Lewis, MD    403-955-7203    victor.lewis@ahs.ca   
Stollery Children's Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Sarah McKillop, MD       Sarah.McKillop@albertahealthservices.ca   
Canada, British Columbia
BC Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3N1
Contact: Caron Strahlendorf, MD    604-875-3576    cstrahlendorf@cw.bc.ca   
Canada, Nova Scotia
IWK Health Centre Not yet recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Conrad Fernandez    902-470-6839    conrad.fernandez@iwk.nshealth.ca   
Canada, Ontario
McMaster Children's Hospital Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Vicky Breakey, MD       breakev@mcmaster.ca   
Children's Hospital London Health Sciences Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Serina Patel, MD    519.685.8500 ext 52678    Serina.Patel@lhsc.on.ca   
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Donna Johnston, MD    613-737-7600 ext 2751    djohnston@cheo.on.ca   
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Paul Nathan, MD    416-813-7743    paul.nathan@sickkids.ca   
Canada, Quebec
Montreal Children's Hospital Not yet recruiting
Montréal, Quebec, Canada, H4A 3J1
Contact: Christine Sabapathy, MD    514-412-4445    christine.sabapathy@mcgill.ca   
Sponsors and Collaborators
The Hospital for Sick Children
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jennifer Stinson, Senior Scientist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03632343    
Other Study ID Numbers: 1000060765
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jennifer Stinson, The Hospital for Sick Children:
self-management
pain
adolescents
mHealth
Additional relevant MeSH terms:
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Neoplasms, Second Primary
Neoplasms