Advanced CancerNCT06117709
Integrated Smartphone Technology to Alleviate Malignant Pain (I-STAMP) Testing
A study testing I-STAMP in people with Advanced Cancer and Pain, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Advanced Cancer, Pain
- What is being tested?
- I-STAMP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Andrea Enzinger, MD, 617-582-7335, andrea_enzinger@dfci.harvard.edu
Andrea Enzinger, MD
About this study
Official title: Integrated Smartphone Technology to Alleviate Malignant Pain (I-STAMP): Development, Usability, and Acceptability Testing
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.
Read the 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.
- Conditions
- Advanced Cancer, Pain
- Being tested
- I-STAMP
- Keywords
- Advanced Cancer, Pain management, Opioid pain management
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-STAMPBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: I-STAMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start18 Sep 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Enzinger, MD, Dana-Farber Cancer Institute
- Investigators
- Andrea Enzinger, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117709
- Sponsor's protocol ID
- 23-187
- Status last verified
- Jul 2026
- First submitted
- 31 Oct 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Smartphone Technology to Alleviate Malignant Pain (I-STAMP): Development, Usability, and Acceptability Testing
- ClinicalTrials.gov ID
- NCT06117709
- Acronym / sponsor ID
- 23-187
- Conditions
- Advanced Cancer, Pain
- Keywords
- Advanced Cancer, Pain management, Opioid pain management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 18 Sep 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I-STAMP Testing | Experimental | Behavioral: I-STAMPStudy procedures will be conducted as follows: Activities 1-3: Data Collection for application development Activity 4: To be added with future amendment |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-STAMPA 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. | Behavioural | I-STAMP Testing |
Primary outcome
Usability
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Enzinger, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-STAMP in people with Advanced Cancer and Pain, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Enzinger, MD (617-582-7335, Andrea_Enzinger@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.