Clinical trial NCT03717402: Smartphone Technology to Alleviate Malignant Pain (STAMP)
Official title: Smartphone Technology to Alleviate Malignant Pain (STAMP): Development and Piloting of a Novel mHealth Intervention to Support Cancer Patients, Nurses, and Physicians in Opioid Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Pain Management
Opioid Use
Keywords: Cancer
Pain management
Opioid use
Health app
Gastrointestinal cancer
Breast cancer
Lung cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2018-10-24
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the study is to develop the STAMP app (Smartphone Technology to Alleviate Malignant Pain). This app will be used by patients with advanced cancer to track symptoms and receive tailored symptom management advice.

This is a single arm pilot feasibility study of the application among patients with advanced cancer and chronic pain who are using opioids in the home setting. Patients will be asked to use the application for a four week period. Clinicians responsible for the patients' pain management will be asked to review alerts from the STAMP system and respond accordingly. The primary outcomes of the study relate to feasibility and acceptability.

Detailed description: A pilot study will be conducted at DFCI to demonstrate the utilization and efficacy of the STAMP app among patients with chronic cancer pain and their cancer care providers. This will be a single arm study with up to 20 patients. Patients with advanced solid tumors who are using opioids to manage chronic cancer pain will be recruited from outpatient clinics (palliative care), and they will be asked to use the app for 4 weeks. Once a patient is enrolled in the study, a research assistant (RA) will set up the app, putting in the patient's prescribed opioids and laxatives. Patient will have access to educational materials about pain management and patient educational videos about pain management and opioids through the app. Patient will be prompted to take daily surveys for symptom reporting and medication updates. At the end of each survey patients receive, a summary of their symptom severity, with links to tailored educational content about pain management, and recommendations about how to safely titrate over-the-counter laxatives to manage opioid-induced constipation. This laxative advice operates within the parameters of normative and approved over-the-counter laxative use, and has been extensively reviewed, vetted, and approved by multidisciplinary groups of clinicians. If patients report any severe symptoms, they are instructed to contact their care team immediately, with a telephone number included on the application screen. If patients' pain is poorly controlled but not severe enough to be prompted to immediately contact their care team (for example if their average pain is above a 4 and not acceptable), they are reminded to contact their care teams if their symptoms worsen or they are concerned about it. Finally, if they report any concerning abdominal symptoms (e.g. no bowel movement in 4 or more days, haven't passed gas from bottom or ostomy, new or severe abdominal pain, vomiting two or more times in the past 24 hours), patients are not given any laxative titration instructions and are instead advised to contact their care team for more advice.

The research team will monitor the portal where patient survey responses are presented. If a severe symptom is reported, the research team will contact the relevant nursing staff for clinical follow-up (as per the above paragraph, patients are always advised to contact their care teams for safety concerns, and there is no expectation for immediate nurse outreach). Nurses and physicians involved in the care of participating patients will also have access to patient-responses on the clinician portal.

Participants will complete a brief survey at baseline and again at end of study (4 weeks). They will also be offered an optional qualitative debriefing at end of study.

Eligibility criteria: Inclusion Criteria:

Patient Inclusion Criteria:

* Patient is cared for within participating clinic (PC)
* Age ≥21
* Diagnosed with locally advanced, metastatic solid tumor, or multiple myeloma being managed with palliative intent
* Chronic pain related to cancer or cancer treatment, persisting or at least two weeks
* Average pain rating of ≥4/10 currently, or at least one day within the past week
* Active prescription for short and/or long acting opioids
* Takes at least 1 opioid medication on most days
* Own a compatible smartphone:
* iPhone, have updated or willing to update it to the past 3 iOS version releases
* Android flagship devices with more than 5% market share, last 2 android version releases

Clinician Inclusion Criteria:

* Physicians and mid-level providers practicing in participating clinics and caring for a patient on the study
* Nurse Navigators working within participating clinics

Exclusion Criteria:

Patient Exclusion Criteria:

* Cognitive impairment that would interfere with study participation, as judged by treating clinician
* Inability to speak English
* History of opioid use disorders
* Enrolled in hospice
* Currently hospitalized
* Use of opioids not supported by STAMP
* Pain primarily related to a recent surgery
* Currently has or has had recurrent bowel obstructions
* The following special populations are excluded: adults unable to consent, prisoners, and pregnant women.

Clinician Exclusion Criteria:

- Unwilling to participate

Primary outcomes:
measure: Frequency of Patient Log Ins
timeFrame: 4 Weeks
measure: Frequency of Symptom Survey Completion
timeFrame: 4 weeks
Secondary outcomes:
measure: E-scale Acceptability
timeFrame: 4 Weeks
measure: Usability
timeFrame: 4 Weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Andrea Enzinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Tariman JD, Berry DL, Halpenny B, Wolpin S, Schepp K. Validation and testing of the Acceptability E-scale for web-based patient-reported outcomes in cancer care. Appl Nurs Res. 2011 Feb;24(1):53-8. doi: 10.1016/j.apnr.2009.04.003. Epub 2009 Sep 18.