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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 : 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

Tracking Information
First Submitted Date  ICMJE February 18, 2014
First Posted Date  ICMJE February 24, 2014
Last Update Posted Date June 27, 2022
Actual Study Start Date  ICMJE February 2014
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2022)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 20, 2014)		 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2022)
  • 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
  • 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)
  • Engagement as tracked by the app [ Time Frame: up to 8 weeks ]
    Pattern of patient engagement with the study's mobile application
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2014)
  • Quality of Life [ Time Frame: 4 & 8-weeks ]
    • ESAS-r
    • FACT-G
  • 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
  • Adherence to analgesic medications [ Time Frame: 4 & 8-weeks ]
    MMAS-8
  • Daily opioid consumption [ Time Frame: 4 & 8-weeks ]
    Measured by oral morphine equivalent daily dose
  • Perceived barriers to cancer pain management [ Time Frame: 4 & 8-weeks ]
    BQ-II
  • Knowledge of pain management [ Time Frame: 4 & 8-weeks ]
    PPQ-K
  • Engagement [ Time Frame: 4 & 8-weeks ]
    Pattern of patient engagement with the study's mobile application
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pain Management in Cancer Patients Using a Mobile Application
Official Title  ICMJE Pain Management in Cancer Patients Using a Mobile Application
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Cancer
Intervention  ICMJE Other: ePAL Mobile Application
A mobile application designed to help cancer patients better self-manage cancer pain.
Other Name: ePAL
Study Arms  ICMJE
  • Experimental: Intervention
    The intervention group will use the study's mobile application during the 8-week study.
    Intervention: Other: ePAL Mobile Application
  • No Intervention: Control
    The control group will not use the study's mobile application during the study.
Publications * Agboola S, Kamdar M, Flanagan C, Searl M, Traeger L, Kvedar J, Jethwani K. Pain management in cancer patients using a mobile app: study design of a randomized controlled trial. JMIR Res Protoc. 2014 Dec 12;3(4):e76. doi: 10.2196/resprot.3957.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2014)		 110
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2020
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02069743
Other Study ID Numbers  ICMJE 13-080
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Mihir M. Kamdar,M.D., Massachusetts General Hospital
Original Responsible Party Kamal Jethwani, Massachusetts General Hospital, Corporate Manager - Research & Innovation
Current Study Sponsor  ICMJE Massachusetts General Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE McKesson Foundation
Investigators  ICMJE
Principal Investigator: Kamal Jethwani, MD, MPH Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP