Cancer
Conditions
Keywords
cancer pain
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.
Interventions
OTHERePAL Mobile Application
A mobile application designed to help cancer patients better self-manage cancer pain.
Sponsors
McKesson Foundation
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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) |
Countries
United States
Outcome results
None listed