Smartphone Technology to Alleviate Malignant Pain (STAMP)

Cancer Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cancer
• Opioid Use
• Pain Management

• NCT number: NCT03717402
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Completion date: May 1, 2022