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Pain Management in Cancer Patients Using a Mobile Application (ePAL)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02069743
Recruitment Status : Active, not recruiting
First Posted : February 24, 2014
Last Update Posted : December 12, 2018
Sponsor:
Collaborator:
McKesson Foundation
Information provided by (Responsible Party):
Kamal Jethwani, Massachusetts General Hospital

Brief Summary:
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 achieve greater reductions in cancer-related pain and improved quality of life.

Condition or disease Intervention/treatment Phase
Cancer Other: ePAL Mobile Application Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pain Management in Cancer Patients Using a Mobile Application
Study Start Date : February 2014
Actual Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
The intervention group will use the study's mobile application during the 8-week study.
Other: ePAL Mobile Application
A mobile application designed to help cancer patients better self-manage cancer pain.
Other Name: ePAL

No Intervention: Control
The control group will not use the study's mobile application during the study.



Primary Outcome Measures :
  1. Pain intensity [ Time Frame: 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 Outcome Measures :
  1. Quality of Life [ Time Frame: 4 & 8-weeks ]

    ESAS-r

    • FACT-G


  2. Hospital utilization for pain crisis [ Time Frame: 4 and 8-weeks ]
    • In-patient and out-patient hospital visits
    • Urgent non-scheduled clinic visits for pain crisis

  3. Daily opioid consumption [ Time Frame: 4 & 8-weeks ]
    Measured by oral morphine equivalent daily dose

  4. Perceived barriers to cancer pain management [ Time Frame: 4 & 8-weeks ]
    BQ-II

  5. Knowledge of pain management [ Time Frame: 4 & 8-weeks ]
    PPQ-K

  6. Engagement [ Time Frame: 4 & 8-weeks ]
    Pattern of patient engagement with the study's mobile application



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02069743


Locations
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United States, Massachusetts
The Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Massachusetts General Hospital
McKesson Foundation
Investigators
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Principal Investigator: Kamal Jethwani, MD, MPH Massachusetts General Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kamal Jethwani, Corporate Manager - Research & Innovation, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02069743    
Other Study ID Numbers: 13-080
First Posted: February 24, 2014    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Keywords provided by Kamal Jethwani, Massachusetts General Hospital:
cancer pain