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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03717402
• Other study ID #: 18-504
• Secondary ID: 1R21NR017745-01
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: May 1, 2022

Study information

• Verified date: May 2023
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Opioid Use
• Pain Management

Intervention

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.

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (7)

Breivik H, Cherny N, Collett B, de Conno F, Filbet M, Foubert AJ, Cohen R, Dow L. Cancer-related pain: a pan-European survey of prevalence, treatment, and patient attitudes. Ann Oncol. 2009 Aug;20(8):1420-33. doi: 10.1093/annonc/mdp001. Epub 2009 Feb 24. — View Citation

Cleeland CS, Gonin R, Hatfield AK, Edmonson JH, Blum RH, Stewart JA, Pandya KJ. Pain and its treatment in outpatients with metastatic cancer. N Engl J Med. 1994 Mar 3;330(9):592-6. doi: 10.1056/NEJM199403033300902. — View Citation

Dalal S, Bruera E. Access to opioid analgesics and pain relief for patients with cancer. Nat Rev Clin Oncol. 2013 Feb;10(2):108-16. doi: 10.1038/nrclinonc.2012.237. Epub 2013 Jan 15. — View Citation

Deandrea S, Montanari M, Moja L, Apolone G. Prevalence of undertreatment in cancer pain. A review of published literature. Ann Oncol. 2008 Dec;19(12):1985-91. doi: 10.1093/annonc/mdn419. Epub 2008 Jul 15. — View Citation

Jadad AR, Browman GP. The WHO analgesic ladder for cancer pain management. Stepping up the quality of its evaluation. JAMA. 1995 Dec 20;274(23):1870-3. — View 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. — View Citation

van den Beuken-van Everdingen MH, Hochstenbach LM, Joosten EA, Tjan-Heijnen VC, Janssen DJ. Update on Prevalence of Pain in Patients With Cancer: Systematic Review and Meta-Analysis. J Pain Symptom Manage. 2016 Jun;51(6):1070-1090.e9. doi: 10.1016/j.jpainsymman.2015.12.340. Epub 2016 Apr 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Patient Log Ins	We will calculate the frequency that patients log in to the application using simple descriptive statistics.	4 Weeks
Primary	Frequency of Symptom Survey Completion	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	E-scale Acceptability	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
Secondary	Usability	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