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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I-STAMP Testing | Experimental | Study procedures will be conducted as follows: Activities 1-3: Data Collection for application development Activity 4: To be added with future amendment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I-STAMP | Behavioral | 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. |
| 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 |
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Inclusion Criteria for Participants (Activities 1a, 2a, 3a):
Exclusion Criteria for Participants (Activities 1a, 2a, 3a):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Enzinger, MD | Contact | 617-582-7335 | Andrea_Enzinger@dfci.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Enzinger, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Data can be shared no earlier than 1 year following the date of publication
DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| C411764 | STAMP-I protocol |
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| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |