Utility of an APP for the Monitoring of Irruptive Oncological Pain

NCT03597737 | Completed

• 1 other identifier: OncoApp
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The present investigation aims at exploring the effect of including a pain app called Pain Monitor irruptive oncological pain for chronic pain patients' daily monitoring. Two conditions will be set:

1. 1.usual treatment (waiting list)
2. 2.usual treatment + APP

Conditions

Oncology; Pain, Acute; Pain, Chronic

Outcome Measures

Primary Outcomes (2)

• Change in average pain intensity in the past week assessed by a Numerical Rating Scale in the Brief Pain Inventory-Short Form

  The Brief Pain Inventory-Short Form (BPI-SF) will be used to measure average pain intensity. The item has a response range from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores represent higher pain intensity levels

  Twice (first day of study and 30 days after, at the end of study)

• Change in side effects of pain medication

  A list of the most frequent side effects of pain medication has been created. Responses are dichotomous (0=did not experience the side effect; 1=experienced the side effect)

  Twice (first day of study and 30 days after, at the end of study)

Secondary Outcomes (7)

• Change in depression measured by the Sadness scale in the POMS

  Twice (first day of study and 30 days after, at the end of study)

• Change in anxiety measured by the Tension scale in the POMS

  Twice (first day of study and 30 days after, at the end of study)

• Change in the amount of rescue medication used in the past week

  Twice (first day of study and 30 days after, at the end of study)

• Change in average interference of pain in functioning in the past week measured by a Numerical Rating Scale in the Brief Pain Inventory-Short Form

  Twice (first day of study and 30 days after, at the end of study)

• Change in physical health status measured with the Physical Composite Score in the SF12

  Twice (first day of study and 30 days after, at the end of study)

Study Arms (1)

Treatment as usual + APP

EXPERIMENTAL

Participants at this condition will receive the usual medical treatment for their pain but also they will be monitored daily using the Pain Monitor APP. Alarms will be generated in the face of certain preestablished events. Physicians will be asked to call patients and change/stop treatment if an alarm is received.

Device: Pain APP

Interventions

Pain APP DEVICE

pain app Pain Monitor app has been developed by a multidisciplinary pain expert panel, including physicians, psychologists, and nurses. Content has been validated in a previous study and usability has been shown to be excellent.

Treatment as usual + APP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is over 18 years of age
• Irruptive oncological pain
• The patient has a mobile phone with Android operating system
• The patient has the physical ability to use the application
• The patient does not present psychological and / or cognitive alterations or problems with language that make their participation difficult- The patient voluntarily wants to participate and signs the informed consent

You may not qualify if:

• The patient is under 18 years
• The patient does not have a mobile phone or has a mobile phone in which Android is not the operating system (the app is currently only available for Android for economic reasons)
• The patient does not have the physical capacity to use the application
• The patient does not have the capacity to participate due to psychological and / or cognitive alterations or problems with language
• The patient does not want to participate

Sponsors & Collaborators

• Universitat Jaume I: lead

Study Sites (1)

Consorcio Hospitalario Provincial de Castellón

Castellon, Spain

Location

Related Publications (4)

• Suso-Ribera C, Castilla D, Zaragoza I, Ribera-Canudas MV, Botella C, Garcia-Palacios A. Validity, Reliability, Feasibility, and Usefulness of Pain Monitor: A Multidimensional Smartphone App for Daily Monitoring of Adults With Heterogenous Chronic Pain. Clin J Pain. 2018 Oct;34(10):900-908. doi: 10.1097/AJP.0000000000000618.

  PMID: 29659375 BACKGROUND

• Garcia-Palacios A, Herrero R, Belmonte MA, Castilla D, Guixeres J, Molinari G, Banos RM. Ecological momentary assessment for chronic pain in fibromyalgia using a smartphone: a randomized crossover study. Eur J Pain. 2014 Jul;18(6):862-72. doi: 10.1002/j.1532-2149.2013.00425.x. Epub 2013 Nov 22.

  PMID: 24921074 BACKGROUND

• Olorunto WA, Galandiuk S. Managing the spectrum of surgical pain: acute management of the chronic pain patient. J Am Coll Surg. 2006 Jan;202(1):169-75. doi: 10.1016/j.jamcollsurg.2005.08.007. Epub 2005 Oct 19. No abstract available.

  PMID: 16377510 BACKGROUND

• Porta-Sales J, Garzon Rodriguez C, Julia Torras J, Casals Merchan M. [Cancer-related breakthrough pain]. Med Clin (Barc). 2010 Jul 17;135(6):280-5. doi: 10.1016/j.medcli.2010.02.008. Epub 2010 May 6. No abstract available. Spanish.

  PMID: 20451223 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Acute Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Azucena García-Palacios, PhD

  Universitat Jaume I

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Patients will be informed of the condition they have been assigned to.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One condition

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: July 24, 2018
• Study Start: August 10, 2018
• Primary Completion: March 28, 2019
• Study Completion: November 29, 2020
• Last Updated: April 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)