Smartphone Technology to Alleviate Malignant Pain (STAMP)

NCT03717402 | Completed Results

• 2 other identifiers: 18-5041R21NR017745-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Pain Management; Opioid Use

Keywords

Cancer; Pain management; Opioid use; Health app; Gastrointestinal cancer; Breast cancer; Lung cancer

Outcome Measures

Primary Outcomes (2)

• Frequency of Patient Log Ins

  We will calculate the frequency that patients log in to the application using simple descriptive statistics.

  4 Weeks

• 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 Outcomes (2)

• E-scale Acceptability

  4 Weeks

• Usability

  4 Weeks

Study Arms (1)

Intervention Participants

OTHER

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

Interventions

Intervention Participants BEHAVIORAL

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.

Intervention Participants

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• \- Unwilling to participate

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (8)

• 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.

  PMID: 27112310 BACKGROUND

• 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.

  PMID: 23319138 BACKGROUND

• 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.

  PMID: 7500538 BACKGROUND

• 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.

  PMID: 18632721 BACKGROUND

• 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.

  PMID: 19244085 BACKGROUND

• 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.

  PMID: 7508092 BACKGROUND

• 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.

  PMID: 20974066 BACKGROUND

• Azizoddin DR, Hassett M, Anderson KS, Kessler D, Wright A, Gorra M, Kematick B, Chua I, Brandoff D, Lally K, Nabati L, MacIsaac S, Tulsky JA, Enzinger A. MyPainPal, a Novel mHealth App to Improve Pain in Patients With Advanced Cancer: Single-Arm Pilot Study. JMIR Cancer. 2025 Dec 30;11:e79942. doi: 10.2196/79942.

  PMID: 41468579 DERIVED

MeSH Terms

Conditions

Neoplasms; Agnosia; Gastrointestinal Neoplasms; Breast Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Andrea C. Enzinger, MD
• Organization: Dana-Farber Cancer Institute

Andrea_Enzinger@DFCI.HARVARD.EDU

617-582-7335

Study Officials

• Andrea Enzinger, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 24, 2018
• Study Start: November 1, 2018
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: June 5, 2023
• Results First Posted: June 5, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)