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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06117709
• Other study ID #: 23-187
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: Dana-Farber Cancer Institute
• Contact: Andrea Enzinger, MD
• Phone: 617-582-7335
• Email: Andrea_Enzinger[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 73
• Est. completion date: April 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Pain

Intervention

Behavioral:
• 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	The Fund for Innovation in Cancer Informatics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks
Primary	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.	2 weeks