Smartphone App for Cancer-Related Pain Management

Overseen By Andrea Enzinger, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Visual impairment, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app called I-STAMP to determine if it helps people with cancer manage pain and track medications. The goal is to see if the app eases cancer-related pain management. It suits those diagnosed with advanced cancer who have experienced cancer pain. The trial will gather information to further develop the app. Participants must understand, speak, and read English to join. As an unphased trial, this study offers a unique opportunity to contribute to developing a potentially helpful tool for managing cancer pain.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems the study focuses on using a smartphone app to help manage cancer pain and track medications, so you might be able to continue your current treatment.

What prior data suggests that the I-STAMP app is safe for managing cancer-related pain?

Research shows that the I-STAMP app is being developed to help people manage cancer-related pain. Studies have found that similar apps, like STAMP + CBT, are easy to use and effective for pain management.

Specific safety data for I-STAMP is not yet available, but as a smartphone app, it is considered low-risk. These apps typically help track symptoms and offer tips for better pain management, making them safer than treatments like drugs or surgery.

No reports of negative effects from using the app have surfaced so far. Since I-STAMP is not a medication or surgical treatment, it is likely to be well-tolerated by most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the I-STAMP app because it represents a new approach to managing cancer-related pain using digital technology. Unlike traditional pain management treatments that often rely on medications like opioids, the I-STAMP app offers an innovative method for tracking and managing pain through personalized data collection and analysis. This app could empower patients by allowing them to actively participate in their pain management, potentially leading to more precise and individualized treatment plans without the side effects associated with medication.

What evidence suggests that the I-STAMP app is effective for managing cancer-related pain?

Research has shown that mobile health tools like the STAMP app can help cancer patients learn to manage their pain, potentially reducing their pain levels. In this trial, participants will use the I-STAMP app, which is based on cognitive behavioral therapy (CBT), to provide both mental and medical support for handling cancer pain. The app enables patients to track their pain, mood, and medication use, aiding in better pain management. Overall, early results suggest that the STAMP app could be a valuable tool for those experiencing cancer-related pain. ^{2 3 6 7 8}

Who Is on the Research Team?

Andrea Enzinger, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults over 21 years old who have advanced cancer and are currently experiencing or have experienced cancer-related pain. It's not specified who can't join, but typically those with conditions that could interfere with the app usage or study participation would be excluded.

Inclusion Criteria

I have been diagnosed with advanced cancer.

I have experienced pain due to my cancer.

I am 21 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Data Collection

Activities 1-3 involve non-interventional data collection for application development

Usability and Acceptability Testing

Participants complete usability and acceptability assessments using validated scales

2 weeks

Follow-up

Participants are monitored for feedback and further data collection after initial testing

What Are the Treatments Tested in This Trial?

Interventions

• I-STAMP

Trial Overview The I-STAMP trial is testing a smartphone app designed to help people with cancer manage their pain better. The app also helps track medication use to see if it improves symptom management.

How Is the Trial Designed?

Group I: I-STAMP Testing Experimental Treatment 1 Intervention

Study procedures will be conducted as follows: Activities 1-3: Data Collection for application development Activity 4: To be added with future amendment

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

The Fund for Innovation in Cancer Informatics

Collaborator

Trials

1

Recruited

70+

Published Research Related to This Trial

In a study of 139 breast cancer patients undergoing chemotherapy, using a mobile app for symptom tracking improved the stabilization of daily functional activity when patients reviewed their data with a physician, compared to those who used the app unsupervised.

Patients using the app reported more adverse events than those using traditional questionnaires, indicating that the app enhances awareness and reporting of chemotherapy side effects, particularly when used in a supervised setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial. Egbring, M., Far, E., Roos, M., et al.[2022]

The mobile health platform Manage My Pain was well-accepted by patients at the Transitional Pain Service, with 67% of participants consenting to use it and 61% completing registration, indicating its potential as a valuable tool for pain self-management.

User retention rates were promising, with 67.9% of users continuing to engage with the app after 30 days and 43.2% after 90 days, suggesting that the app effectively supports ongoing pain monitoring and communication with healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement with Manage My Pain mobile health application among patients at the Transitional Pain Service. Slepian, PM., Peng, M., Janmohamed, T., et al.[2022]

The study aims to evaluate a smartphone application designed for real-time reporting of adverse events in cancer treatments, which could enhance early detection and management of side effects, ultimately improving patient safety and treatment outcomes.

The trial will involve 66 patients over six months, assessing the feasibility of the app and comparing the quality of life and therapy doses between those using the app and those receiving standard care, highlighting the importance of patient-reported symptoms in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol. Kestler, AMR., Kühlwein, SD., Kraus, JM., et al.[2021]

The Pain Squad app, designed for adolescents with cancer, effectively collects detailed pain data and has shown high compliance rates of 81% during a 2-week feasibility trial, indicating its usability and acceptance among users.

The app's game-based design and reward system were particularly appealing to adolescents, contributing to their satisfaction and consistent use, which is crucial for better pain management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and testing of a multidimensional iPhone pain assessment application for adolescents with cancer. Stinson, JN., Jibb, LA., Nguyen, C., et al.[2022]

A pilot study with 30 cancer patients showed that mobile pain coping skills training (mPCST) delivered via Skype is feasible and has low burden on patients, leading to high engagement and acceptability.

Patients using mPCST experienced significant reductions in pain severity and improved self-efficacy for pain management, with results comparable to those receiving traditional in-person training, indicating that mPCST can be an effective alternative for managing cancer pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Small Randomized Controlled Pilot Trial Comparing Mobile and Traditional Pain Coping Skills Training Protocols for Cancer Patients with Pain. Somers, TJ., Kelleher, SA., Westbrook, KW., et al.[2020]

A pilot study involving 40 women with breast cancer showed that using a symptom management mobile application alongside usual care led to better quality of life and lower severity of depression compared to those receiving only usual care.

The intervention group experienced less decline in general health and physical functioning during chemotherapy, suggesting that the mobile app may effectively support emotional and physical well-being during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Application for Symptom Management in Patients With Breast Cancer. Seven, M., Paşalak, Ş., Bagcivan, G., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11088794/

Development and pre-pilot testing of STAMP + CBT The STAMP + CBT app was an acceptable and feasible method to deliver psychological/behavioral treatment with pharmacologic support for cancer pain.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05774197?cond=%22Vision+Disorders%22

Psychological Intervention Using Smartphone Technology ... The purpose of this study is to develop and pilot test a novel medical intervention (STAMP+CBT app) that will help patients track their pain, mood, opioid use ...

3. withpower.com withpower.com/trial/phase-palliative-care-9-2022-38927

STAMP+CBT App for Cancer Pain · Info for Participants Research shows that mobile health technologies, like the STAMP+CBT app, can effectively teach cancer patients pain coping skills, leading to reduced pain ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-04363

Evaluating the STAMP+CBT Mobile Application for ... This study may help researchers learn whether the STAMP+CBT is useful for improving pain management in patients with advanced cancer and pain. Eligibility ...

5. jpsmjournal.com jpsmjournal.com/article/S0885-3924(24)00800-5/abstract

A Digital Therapeutic Application (ePAL) to Manage Pain in ... We conducted a randomized trial of a digital therapeutic app (ePAL) for patients with advanced cancer receiving care in a specialty ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06117709

Integrated Smartphone Technology to Alleviate Malignant ... The goal of this study is to develop and refine I-STAMP (Integrated Smartphone Technology to Alleviate Malignant Pain), an electronic health ...

7. trial.medpath.com trial.medpath.com/clinical-trial/f7f532640133f71f/nct06722014-integrating-pain-cbt-mhealth-analgesic-support-chronic-pain-cancers

Integrating Pain-CBT Into an mHealth Analgesic Support ... The app is intended to improve self-management of cancer-related pain. The study will begin with Cohort A, followed by Cohort B. These two cohorts are to ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05403801

NCT05403801 | STAMP+CBT mHealth for Cancer Pain The purpose of this study is to test whether a mobile application developed to help people with cancer pain is useful and helpful to patients with cancer.