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Not yet recruiting NCT06117709

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

No phase Interventional Advanced Cancer Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: I-STAMP.
Who it may be relevant to
Registry conditions: Advanced Cancer, Pain. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Usability [Time frame: 2 weeks]
  • E-scale Acceptability [Time frame: 2 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Dana Farber Cancer Institute — Boston

Identifiers

NCT: NCT06117709 · 23-187

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗