Pain Management in Cancer Patients Using a Mobile Application

Cancer Clinical Trial

— ePAL  

Official title:

Pain Management in Cancer Patients Using a Mobile Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02069743
• Other study ID #: 13-080
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: September 2020

Study information

• Verified date: June 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 2020
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• ePAL Mobile Application
A mobile application designed to help cancer patients better self-manage cancer pain.

Locations

Country	Name	City	State
United States	The Massachusetts General Hospital	Boston	Massachusetts
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	McKesson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Engagement as tracked by the app	Pattern of patient engagement with the study's mobile application	up to 8 weeks
Secondary	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
Secondary	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