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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Advanced Cancer, Pain

Intervention / Treatment
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* Behavioral: I-STAMP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I-STAMP Testing<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Cancer, Pain management, Opioid pain management