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NCT Number: NCT06117709

Integrated Smartphone Technology to Alleviate Malignant Pain (I-STAMP) Testing

The purpose of the study is to evaluate if the smartphone app, I-STAMP (Integrated Smartphone Technology to Alleviate Malignant Pain), helps participants with cancer pain manage symptoms and keep track of medications.

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Key information

Conditions

Advanced Cancer Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location contact

Andrea Enzinger, MD

CONTACT

[email protected]

617-582-7335

Andrea Enzinger, MD

PRINCIPAL_INVESTIGATOR

About this study

The goal of this study is to develop and refine I-STAMP (Integrated Smartphone Technology to Alleviate Malignant Pain), an electronic health record-integrated mobile health (mHealth) application designed to support advanced cancer patients and care teams in pain management.

The research study procedures include screening for eligibility, surveys, and interviews. It is expected that up to 73 participants will take part in this research study. Activities 1-3 are non-interventional and will be used to collect data for application development.

Activity 4: This activity will be interventional and will be added with a future amendment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Participants (Activities 1a, 2a, 3a):

  • Age ≥ 21 years
  • Current or previous diagnosis of advanced cancer
  • Current or previous experience with cancer pain

Exclusion criteria

for Participants (Activities 1a, 2a, 3a):

  • Inability to understand, speak, or read English
  • Any condition that would impede the patient's ability to complete study procedures such as visual impairment or significant cognitive impairment as determined by the participant's treating provider.

Treatment and study plan

I-STAMP

Behavioral

A patient-facing smartphone application that hosts participants' analgesic and laxative medications, provides pain-specific psychoeducation, collects patient reported outcomes, and provides feedback to participant symptoms.

Primary outcomes

  1. Usability

    Time frame: 2 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.

  2. E-scale Acceptability

    Time frame: 2 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Enzinger, MD

CONTACT

[email protected]

617-582-7335

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

Integrated Smartphone Technology to Alleviate Malignant Pain (I-STAMP): Development, Usability, and Acceptability Testing

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 7, 2023
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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