Smartphone Technology to Alleviate Malignant Pain (STAMP)

May 8, 2023 updated by: Andrea Enzinger, MD, Dana-Farber Cancer Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intervention Participants
Patients with advances cancer using opioids for chronic pain will be enrolled and asked to use the STAMP cancer pain management app for 4 weeks.
Behavioral: Intervention Participants
Patients with advances cancer using opioids for chronic pain will be enrolled and asked to use the STAMP cancer pain management app for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Patient Log Ins
Time Frame: 4 Weeks
We will calculate the frequency that patients log in to the application using simple descriptive statistics.
4 Weeks
Frequency of Symptom Survey Completion
Time Frame: 4 weeks
We will calculate the number of times patients completed a symptom survey on app during their 28 days on study. Patients could complete up to one symptom survey per day on study.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
E-scale Acceptability
Time Frame: 4 Weeks
Patients will rate overall acceptability of the application using a modified acceptability e-scale. This 6-item measure asks patients to rate the app on ease of use, understandability, enjoyment, helpfulness, time spent, and overall satisfaction, on a 1 to 5 Likert scale. Items are summed to for a total score, ranging from 6 to 30 with 30 being the highest acceptability score.
4 Weeks
Usability
Time Frame: 4 Weeks
Patients will complete a validated 10-item system usability scale (SUS) with total scores ranging from 0-100, where a score of 100 being the best possible usability score.
4 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Andrea Enzinger, MD, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

October 18, 2018

First Submitted That Met QC Criteria

October 22, 2018

First Posted (Actual)

October 24, 2018

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 18-504
  • 1R21NR017745-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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