Pain Management in Cancer Patients Using a Mobile Application

Massachusetts General Hospital2 sites in 1 country110 target enrollmentFebruary 2014

ConditionsCancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cancer
Sponsor: Massachusetts General Hospital
Enrollment: 110
Locations: 2
Primary Endpoint: Pain symptoms using the Brief Pain Inventory
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

September 2020

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Massachusetts General Hospital

Responsible Party

Principal Investigator

Mihir M. Kamdar,M.D.

Attending Physician

Massachusetts General Hospital

Eligibility 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.

Outcomes

Primary Outcomes

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 Outcomes

Patient-related barriers to pain management using the Barriers Questionnaire-II(up to 8 weeks)
Engagement as tracked by the app(up to 8 weeks)
Anxiety symptoms using the Generalized Anxiety Disorder (GAD-7)(up to 8 weeks)
Pain related hospitalization from the Electronic Health Record(up to 8 weeks)
Quality of life using the Functional Assessment of Cancer Therapy (FACT-G)(up to 8 weeks)