Pain Management in Cancer Patients Using a Mobile Application

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Other: ePAL Mobile Application

• Registration Number: NCT02069743
• Lead Sponsor: 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 have a reduction in pain and pain-related hospitalizations.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-18
• Study First Submitted QC: 2014-02-20
• Study First Posted: 2014-02-24
• Primary Completion: 2018-08
• Study Completion: 2020-09
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	ePAL Mobile Application	The intervention group will use the study's mobile application during the 8-week study.

Primary Outcome Measures

Name	Time	Method
Pain symptoms using the Brief Pain Inventory	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

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

Trial Locations

Locations (2)

The Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States