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

NCT ID: NCT06117709

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-03-30

Brief Summary

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.

Detailed Description

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.

Conditions

Advanced Cancer; Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

I-STAMP Testing

Study procedures will be conducted as follows:

Activities 1-3: Data Collection for application development

Activity 4: To be added with future amendment

Group Type: EXPERIMENTAL

I-STAMP

Intervention Type: 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.

Interventions

I-STAMP

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Andrea Enzinger, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Enzinger, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Central Contacts

Andrea Enzinger, MD

Role: CONTACT

Andrea_Enzinger@dfci.harvard.edu

617-582-7335

Facility Contacts

Andrea Enzinger, MD

Role: primary

andrea_enzinger@dfci.harvard.edu

617-582-7335

Other Identifiers

23-187

Identifier Type: -

Identifier Source: org_study_id