Clinical trial NCT02069743: Pain Management in Cancer Patients Using a Mobile Application
Official title: Pain Management in Cancer Patients Using a Mobile Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: cancer pain
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: McKesson Foundation
First posted: 2014-02-24
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Pain symptoms using the Brief Pain Inventory
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Pain related hospitalization from the Electronic Health Record
timeFrame: up to 8 weeks
measure: Patient-related barriers to pain management using the Barriers Questionnaire-II
timeFrame: up to 8 weeks
measure: Engagement as tracked by the app
timeFrame: up to 8 weeks
measure: Anxiety symptoms using the Generalized Anxiety Disorder (GAD-7)
timeFrame: up to 8 weeks
measure: Quality of life using the Functional Assessment of Cancer Therapy (FACT-G)
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: The Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Massachusetts General Hospital
name: Kamal Jethwani, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.