Pain Management in Cancer Patients Using a Mobile Application

Study Overview
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Brief Summary
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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.

Official Title
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Pain Management in Cancer Patients Using a Mobile Application

Conditions
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Cancer

Intervention / Treatment
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* Other: ePAL Mobile Application


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The intervention group will use the study's mobile application during the 8-week study. | Other: ePAL Mobile Application<br>* A mobile application designed to help cancer patients better self-manage cancer pain.<br>* Other names: ePAL;|
| No Intervention: Control<br>The control group will not use the study's mobile application during the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain symptoms using the Brief Pain Inventory | 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. | up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain related hospitalization from the Electronic Health Record | In-patient and out-patient hospital visits Urgent non-scheduled clinic visits for pain crisis | up to 8 weeks | 
| Patient-related barriers to pain management using the Barriers Questionnaire-II | compared patient-related barriers to pain management using the Barriers Questionnaire-II (BQ-II) | up to 8 weeks | 
| Engagement as tracked by the app | Pattern of patient engagement with the study's mobile application | up to 8 weeks | 
| Anxiety symptoms using the Generalized Anxiety Disorder (GAD-7) | compare anxiety symptoms between the two group using the Generalized Anxiety Disorder (GAD-7) | up to 8 weeks | 
| Quality of life using the Functional Assessment of Cancer Therapy (FACT-G) | to compare quality of life between the two groups using the Functional Assessment of Cancer Therapy -General (FACT-G) | up to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer pain