Skip to main content
OpenTrials
Completed

NCT Number: NCT02069743

Pain Management in Cancer Patients Using a Mobile Application

The investigators have developed a mobile application (for use on smart phones) to help cancer patients better manage cancer pain. This study is a randomized controlled trial to evaluate the effect of this mobile-based intervention. The investigators' hypothesis is that subjects randomized to the intervention group will have a reduction in pain and pain-related hospitalizations.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer Cancer Pain Neoplasms Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Massachusetts General Hospital, Boston, Massachusetts, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All adult patients, 18 years and above suffering from solid-organ cancer.
  • Diagnosed with moderate or severe cancer pain (i.e. pain intensity score of at least 4/10 on numeric rating scale (NRS)) at the Massachusetts General Hospital (MGH) Palliative Care Center, as determined by the patient's care provider at the MGH Palliative Care Center. Subjects do not need to experience a specific nature of pain for eligibility.
  • Patients must be ambulatory and not currently admitted to the hospital at time of enrollment.
  • Must have a smart phone and be willing to download the study application (Phase II only)
  • Must be able to read and speak English.

Exclusion criteria

  • Life expectancy less than 2-months as determined by the palliative care provider
  • Significant medical or psychiatric co-morbidities (other than depression or anxiety) or cognitive impediments that would prevent participant from being able to utilize the program
  • Known history of substance abuse
  • Patients currently on investigational therapies or other study protocols that may have an impact on pain intensity or quality of life which are main outcomes of this intervention.

Treatment and study plan

ePAL Mobile Application

Other

A mobile application designed to help cancer patients better self-manage cancer pain.

Other names: ePAL

Primary outcomes

  1. Pain symptoms using the Brief Pain Inventory

    Time frame: up to 8 weeks

    The primary aim is to assess the effect of a tailored, multi-dimensional mobile-based intervention on the intensity of cancer pain in cancer patients with moderate to severe pain.

Secondary outcomes

  1. Pain related hospitalization from the Electronic Health Record

    Time frame: up to 8 weeks

    • In-patient and out-patient hospital visits
    • Urgent non-scheduled clinic visits for pain crisis

  2. Patient-related barriers to pain management using the Barriers Questionnaire-II

    Time frame: up to 8 weeks

    compared patient-related barriers to pain management using the Barriers Questionnaire-II (BQ-II)

  3. Engagement as tracked by the app

    Time frame: up to 8 weeks

    Pattern of patient engagement with the study's mobile application

  4. Anxiety symptoms using the Generalized Anxiety Disorder (GAD-7)

    Time frame: up to 8 weeks

    compare anxiety symptoms between the two group using the Generalized Anxiety Disorder (GAD-7)

  5. Quality of life using the Functional Assessment of Cancer Therapy (FACT-G)

    Time frame: up to 8 weeks

    to compare quality of life between the two groups using the Functional Assessment of Cancer Therapy -General (FACT-G)

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • McKesson Foundation

Registry information

Acronym: ePAL

Important dates

Study start
2014
Primary completion
2018
Study completion
2020
First posted
Feb 24, 2014
Registry last updated
Jun 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.