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

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06117709

Collaborator

The Fund for Innovation in Cancer Informatics (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Cancer Pain	Behavioral: I-STAMP	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

73 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2024

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Apr 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	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.

Arm

Intervention/Treatment

Experimental: 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

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.

Outcome Measures

Primary Outcome Measures

Usability [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.
E-scale Acceptability [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

Dana-Farber Cancer Institute
The Fund for Innovation in Cancer Informatics

Investigators

Principal Investigator: Andrea Enzinger, MD, Dana-Farber Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andrea Enzinger, MD, Principal Investigator, Dana-Farber Cancer Institute

ClinicalTrials.gov Identifier:

NCT06117709

Other Study ID Numbers:

23-187

First Posted:

Nov 7, 2023

Last Update Posted:

Nov 7, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Andrea Enzinger, MD, Principal Investigator, Dana-Farber Cancer Institute

Advanced Cancer

Pain management

Opioid pain management

Study Results

No Results Posted as of Nov 7, 2023