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

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ClinicalTrials.gov Identifier: NCT02069743
Recruitment Status : Completed
First Posted : February 24, 2014
Last Update Posted : June 27, 2022
Sponsor:
Collaborator:
McKesson Foundation
Information provided by (Responsible Party):
Mihir M. Kamdar,M.D., Massachusetts General Hospital

Study Description
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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 have a reduction in pain and pain-related hospitalizations.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Study Start Date : February 2014
Actual Primary Completion Date : August 2018
Actual Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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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.
Contacts and Locations
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mihir M. Kamdar,M.D., Attending Physician, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02069743    
Other Study ID Numbers: 13-080
First Posted: February 24, 2014    Key Record Dates
Last Update Posted: June 27, 2022
Last Verified: June 2022
Keywords provided by Mihir M. Kamdar,M.D., Massachusetts General Hospital:
cancer pain