PainNCT06722014
Integrating Pain-CBT Into an mHealth Analgesic Support Intervention for Patients With Chronic Pain From Advanced Cancers
A study testing STAMP + CBT and Digital Cancer Pain Education Packet in people with Pain and Pain Syndrome, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
Smartphone Technology to Alleviate Malignant Pain (STAMP) + Cognitive Behavioral Therapy for Pain (STAMP+CBT) The purpose of the study is to develop and refine the mHealth pain-CBT app intervention and carry out a randomized pilot to test the novel mHealth (Mobile health technology) intervention, which harmonizes… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Pain, Pain Syndrome, Advanced Cancer
- What is being tested?
- STAMP + CBT and Digital Cancer Pain Education Packet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 22 years
- Patient diagnosed with an active cancer diagnosis (locally advanced solid tumor malignancy, multiple myeloma, or other advanced hematologic malignancy), either undergoing active treatment or receiving treatment for an advanced cancer or are receiving supportive/palliative care
- Chronic pain related to cancer or treatment (> pain score of 4 on a 0-10 scale)
- Has an active prescription for at least one opioid medication to treat their cancer pain (i.e. not for post-surgical pain)
- Own/use a compatible smartphone (iPhone or Android)
Who cannot join
- Patients in survivorship: patients who have completed their treatment regimens, are not actively receiving treatment for an advanced cancer, or have a cancer that is in remission
- Cognitive impairment that would interfere with study participation, as judged by treating clinician (e.g. delirium, dementia)
- Inability to speak English (the intervention has not yet been translated to Spanish)
- Currently in CBT treatment
- Enrolled in hospice
- Currently hospitalized
Show all 10Show fewer
- Use of transmucosal fentanyl, given safety concerns and ongoing risk mitigation program required to prescribe these (TIRF REMS)
- Pain primarily related to a recent surgery (within the last 2 weeks)
- Conditions that hinder smartphone use
- The study will exclude adults who are unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, and prisoners.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Smartphone Technology to Alleviate Malignant Pain (STAMP) + Cognitive Behavioral Therapy for Pain (STAMP+CBT) The purpose of the study is to develop and refine the mHealth pain-CBT app intervention and carry out a randomized pilot to test the novel mHealth (Mobile health technology) intervention, which harmonizes psychological and pharmacological support for advanced cancer pain.
The name of the study smartphone application involved in this study is:
-STAMP+CBT
Read the detailed description
The purpose of the study is to make sure the app is usable and helpful for participants with cancer and to get feedback about participants experiences after using the app for four weeks. Outcomes related to pain, quality of life, and healthcare utilization will also be assessed. The cancer pain education packet and pain and medication monitoring survey are standard care. 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 refine the STAMP+CBT intervention. Then a randomized pilot will be performed, and participants will be randomized into one of two study groups for the pilot: Cohort C: STAMP+CBT versus Cohort D: Digital Cancer Pain Education Packet + Usual Care. Randomization means a participant is placed into a study group by chance.
It is expected that about 60 people will take part in this research study.
The National Institutes of Health, National Cancer Institute (NIH-NCI), is funding this research study.
- Conditions
- Pain, Pain Syndrome, Advanced Cancer
- Being tested
- STAMP + CBT, Digital Cancer Pain Education Packet
- Keywords
- Pain, Pain Syndrome, Advanced Cancer
- Medical subject headings
- Pain, Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAMP + CBTBehavioural
Also called Smartphone Technology to Alleviate Malignant Pain+Cognitive Behavioral Therapy for pain
A mobile health, smartphone application that provides tailored multi-media, cancer pain psycho-education and pain management coping skills using algorithm-based technology to provide in the moment symptom monitoring and feedback.
Digital Cancer Pain Education PacketBehavioural
Packet including Articles from the Association for Clinical Oncology and the National Cancer Institute and the pain and medication monitoring form.
| Study group | Role | What they receive |
|---|---|---|
| Cohort C: STAMP + CBT App | Experimental | Permutated-block randomization and a block size of 6 will be used to randomize 60 participants to this cohort, and participants will complete:
* Baseline in-person or remote visit with an introduction to the STAMP+CBT application.
* Surveys via the application 6 days per week.
* Day 7 check in with study team
* Day 14 survey
* Day 28 follow-up surveys
* Optional in-person or remote semi-structured, exit interview
* Day 42 (Week 6) follow-up survey Receives: Behavioral: STAMP + CBT |
| Cohort D: Digital Cancer Pain Education Packet + Usual Care | Other | Permutated-block randomization and a block size of 6 will be used to randomize 60 participants to this cohort, and participants will complete:
* Baseline in-person or remote visit with introduction to the digital cancer pain education packet and pain tracker form.
* Completion of pain tracker
* Day 7 check in with study team
* Day 14 survey
* Day 28 surveys
* Optional in-person or remote semi-structured, exit interview to review the educational packet
* Day 42 (Week 6) follow-up survey Receives: Behavioral: Digital Cancer Pain Education Packet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall intervention adherence rate (Cohort C)
>70% of subjects complete any activity on the STAMP+CBT application at least 50% of days on study (4-week study period). The app will be considered feasible if this benchmark is achieved.
Measured: Up to 4 weeks
Overall intervention adherence rate (Cohort D)
Defined as completion of the 14- and 28-days surveys, which assesses completion of the pain and medication monitoring reports by participants in the control group.
Measured: Up to 4 weeks
Proportion of participants who rate app acceptability at least 4/5 on the Acceptability E-Scale (Cohort C)
Acceptability of the intervention is defined as > 80% of the participants rate the application as satisfactory and useful with a mean 4 or higher score out of 5 on the Acceptability E-Scale (Tariman 2011). The Acceptability E-Scale a 7-item measure with answer ranging from 1 "Very Difficulty/Difficult to understand/Not at all/Very unacceptable/Very dissatisfied/Not useful/Very unlikely" to 5 "Very Easy/Easy to understand/Very much/ Very acceptable/Very satisfied/Very useful/Very likely" and with a total scores range of 7 to 35 with a higher score representing greater participant acceptability. Subjects will be assigned surveys at baseline, 4 weeks, and 6 weeks. Participants will rate the app on the following 5 domains: understandability, enjoyability, ease of use, time required to use the app, and overall satisfaction. Ratings lower than 4/5 will lead to refinements.
Measured: Up to 6 weeks
Proportion of participants who rate educational packet acceptability at least 4/5 on the Acceptability E-Scale (Cohort D)
Acceptability of the intervention is defined as > 80% of the participants rate the application as satisfactory and useful with a mean 4 or higher score out of 5 on the Acceptability E-Scale (Tariman 2011). The Acceptability E-Scale a 7-item measure with answer ranging from 1 "Very Difficulty/Difficult to understand/Not at all/Very unacceptable/Very dissatisfied/Not useful/Very unlikely" to 5 "Very Easy/Easy to understand/Very much/ Very acceptable/Very satisfied/Very useful/Very likely" and with a total scores range of 7 to 35 with a higher score representing greater participant acceptability. Subjects will be assigned surveys at baseline, 4 weeks, and 6 weeks. Participants will rate the app on the following 5 domains: understandability, enjoyability, ease of use, time required to use the app, and overall satisfaction. Ratings lower than 4/5 will lead to refinements.
Measured: Up to 6 weeks
Secondary outcomes (10)
Number of Enrolled Participants who Consented and Completed the Study (Cohort C)
Defined as the proportion of participants of the intervention group on study for the complete study period. Subjects are defined as individuals who consented and enrolled to the trial and complete study measures and either 28 days of app use (intervention group) or 28 days of education packet review (control group). Rates of completion will be compared between the intervention and control groups.
Measured: 18 months
Number of Enrolled Participants who Consented and Completed the Study (Cohort D)
Defined as the proportion of participants of the control group on study for the complete study period. Subjects are defined as individuals who consented and enrolled to the trial and complete study measures and either 28 days of app use (intervention group) or 28 days of education packet review (control group). Rates of completion will be compared between the intervention and control groups.
Measured: 18 months
Study Retention (Cohort C)
Defined as the proportion of participants of the intervention group on study for the complete study period. Subjects are defined as individuals who consented and enrolled to the trial and complete study measures and either 28 days of app use (intervention group) or 28 days of education packet review (control group). Rates of completion will be compared between the intervention and control groups.
Measured: 18 months
Study Retention (Cohort D)
Defined as the proportion of participants of the control group on study for the complete study period. Subjects are defined as individuals who consented and enrolled to the trial and complete study measures and either 28 days of app use (intervention group) or 28 days of education packet review (control group). Rates of completion will be compared between the intervention and control groups.
Measured: 18 months
Median assessment score on the system usability scale at 4 weeks (Cohort C)
Intervention usability will be assessed by the System Usability Scale (SUS), a 12-item measure rated on a 5-point Likert scale from 1 "Strongly Disagree" to 5 "Strongly Agree" with a total scores range of 0 to 100. A higher score represents greater usability. Subjects will be assigned surveys at baseline, 4 weeks, and 6 weeks. The survey at 4 weeks will assess intervention acceptability with the System Usability Scale (Brooke, 2002). The app will be considered usable if the median score on the System Usability Scale across respondents is >75.
Measured: Up to 6 weeks
Median assessment score on the system usability scale at 4 weeks (Cohort D)
Intervention usability will be assessed by the System Usability Scale (SUS), a 12-item measure rated on a 5-point Likert scale from 1 "Strongly Disagree" to 5 "Strongly Agree" with a total scores range of 0 to 100. A higher score represents greater usability. Subjects will be assigned surveys at baseline, 4 weeks, and 6 weeks. The survey at 4 weeks will assess control education packet acceptability with the System Usability Scale (Brooke, 2002). This information will be used to compare usability scores across intervention and control groups.
Measured: Up to 6 weeks
Change in Brief Pain Inventory (BPI) Pain Interference Score from Baseline to 4 and 6 Weeks (Cohort C)
Assessed by the BPI, a 7-item subscale on pain interference with answers scored on a scale from 0 "Does not interfere" to 10 "Greatly interferes." A total scores range is 0 to 70 with a higher score indicating greater pain interference.
Measured: Up to 6 weeks
Change in BPI Pain Interference Score from Baseline to 4 and 6 Weeks (Cohort D)
Assessed by the BPI, a 7-item subscale on pain interference with answers scored on a scale from 0 "Does not interfere" to 10 "Greatly interferes." A total scores range is 0 to 70 with a higher score indicating greater pain interference.
Measured: Up to 6 weeks
Change in BPI Pain Intensity Score from Baseline to 4 and 6 Weeks (Cohort C)
Assessed by the Brief Pain Inventory (BPI) pain intensity subscale, a 4-item measure on pain intensity with answers scored on a scale from 0 "No pain" to 10 "Pain as bad as you can imagine." A total scores range is 0 to 40 with a higher score indicating greater pain intensity.
Measured: Up to 6 weeks
Change in BPI Pain Intensity Score from Baseline to 4 and 6 Weeks (Cohort D)
Assessed by the Brief Pain Inventory (BPI) pain intensity subscale, a 4-item measure on pain intensity with answers scored on a scale from 0 "No pain" to 10 "Pain as bad as you can imagine." A total scores range is 0 to 40 with a higher score indicating greater pain intensity.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start27 Mar 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Desiree R. Azizoddin PsyD, Dana-Farber Cancer Institute
- Investigators
- Desiree Azizoddine, PsyD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722014
- Sponsor's protocol ID
- 24-286
- Other IDs
- 5K08CA266937
- Status last verified
- May 2025
- First submitted
- 3 Dec 2024
- Last updated
- 8 Jul 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 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Pain-CBT Into an mHealth Analgesic Support Intervention for Patients With Chronic Pain From Advanced Cancers
- ClinicalTrials.gov ID
- NCT06722014
- Acronym / sponsor ID
- 24-286
- Conditions
- Pain, Pain Syndrome, Advanced Cancer
- Keywords
- Pain, Pain Syndrome, Advanced Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 9 Dec 2024 (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.
Smartphone Technology to Alleviate Malignant Pain (STAMP) + Cognitive Behavioral Therapy for Pain (STAMP+CBT) The purpose of the study is to develop and refine the mHealth pain-CBT app intervention and carry out a randomized pilot to test the novel mHealth (Mobile health technology) intervention, which harmonizes psychological and pharmacological support for advanced cancer pain.
The name of the study smartphone application involved in this study is:
-STAMP+CBT
Detailed description
The purpose of the study is to make sure the app is usable and helpful for participants with cancer and to get feedback about participants experiences after using the app for four weeks. Outcomes related to pain, quality of life, and healthcare utilization will also be assessed. The cancer pain education packet and pain and medication monitoring survey are standard care. 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 refine the STAMP+CBT intervention. Then a randomized pilot will be performed, and participants will be randomized into one of two study groups for the pilot: Cohort C: STAMP+CBT versus Cohort D: Digital Cancer Pain Education Packet + Usual Care. Randomization means a participant is placed into a study group by chance.
It is expected that about 60 people will take part in this research study.
The National Institutes of Health, National Cancer Institute (NIH-NCI), is funding this research study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort C: STAMP + CBT App | Experimental | Behavioral: STAMP + CBTPermutated-block randomization and a block size of 6 will be used to randomize 60 participants to this cohort, and participants will complete: * Baseline in-person or remote visit with an introduction to the STAMP+CBT application. * Surveys via the application 6 days per week. * Day 7 check in with study team * Day 14 survey * Day 28 follow-up surveys * Optional in-person or remote semi-structured, exit interview * Day 42 (Week 6) follow-up survey |
| Cohort D: Digital Cancer Pain Education Packet + Usual Care | Other | Behavioral: Digital Cancer Pain Education PacketPermutated-block randomization and a block size of 6 will be used to randomize 60 participants to this cohort, and participants will complete: * Baseline in-person or remote visit with introduction to the digital cancer pain education packet and pain tracker form. * Completion of pain tracker * Day 7 check in with study team * Day 14 survey * Day 28 surveys * Optional in-person or remote semi-structured, exit interview to review the educational packet * Day 42 (Week 6) follow-up survey |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 22 years
- Patient diagnosed with an active cancer diagnosis (locally advanced solid tumor malignancy, multiple myeloma, or other advanced hematologic malignancy), either undergoing active treatment or receiving treatment for an advanced cancer or are receiving supportive/palliative care
- Chronic pain related to cancer or treatment (> pain score of 4 on a 0-10 scale)
- Has an active prescription for at least one opioid medication to treat their cancer pain (i.e. not for post-surgical pain)
- Own/use a compatible smartphone (iPhone or Android)
Key exclusion criteria (10 listed)
- Patients in survivorship: patients who have completed their treatment regimens, are not actively receiving treatment for an advanced cancer, or have a cancer that is in remission
- Cognitive impairment that would interfere with study participation, as judged by treating clinician (e.g. delirium, dementia)
- Inability to speak English (the intervention has not yet been translated to Spanish)
- Currently in CBT treatment
- Enrolled in hospice
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 |
|---|---|---|
| STAMP + CBTAlso: Smartphone Technology to Alleviate Malignant Pain+Cognitive Behavioral Therapy for painA mobile health, smartphone application that provides tailored multi-media, cancer pain psycho-education and pain management coping skills using algorithm-based technology to provide in the moment symptom monitoring and feedback. | Behavioural | Cohort C: STAMP + CBT App |
| Digital Cancer Pain Education PacketPacket including Articles from the Association for Clinical Oncology and the National Cancer Institute and the pain and medication monitoring form. | Behavioural | Cohort D: Digital Cancer Pain Education Packet + Usual Care |
Primary outcome
Overall intervention adherence rate (Cohort C)
Time frame: Up to 4 weeks
>70% of subjects complete any activity on the STAMP+CBT application at least 50% of days on study (4-week study period). The app will be considered feasible if this benchmark is achieved.
Overall intervention adherence rate (Cohort D)
Time frame: Up to 4 weeks
Defined as completion of the 14- and 28-days surveys, which assesses completion of the pain and medication monitoring reports by participants in the control group.
Proportion of participants who rate app acceptability at least 4/5 on the Acceptability E-Scale (Cohort C)
Time frame: Up to 6 weeks
Acceptability of the intervention is defined as > 80% of the participants rate the application as satisfactory and useful with a mean 4 or higher score out of 5 on the Acceptability E-Scale (Tariman 2011). The Acceptability E-Scale a 7-item measure with answer ranging from 1 "Very Difficulty/Difficult to understand/Not at all/Very unacceptable/Very dissatisfied/Not useful/Very unlikely" to 5 "Very Easy/Easy to understand/Very much/ Very acceptable/Very satisfied/Very useful/Very likely" and with a total scores range of 7 to 35 with a higher score representing greater participant acceptability. Subjects will be assigned surveys at baseline, 4 weeks, and 6 weeks. Participants will rate the app on the following 5 domains: understandability, enjoyability, ease of use, time required to use the app, and overall satisfaction. Ratings lower than 4/5 will lead to refinements.
Proportion of participants who rate educational packet acceptability at least 4/5 on the Acceptability E-Scale (Cohort D)
Time frame: Up to 6 weeks
Acceptability of the intervention is defined as > 80% of the participants rate the application as satisfactory and useful with a mean 4 or higher score out of 5 on the Acceptability E-Scale (Tariman 2011). The Acceptability E-Scale a 7-item measure with answer ranging from 1 "Very Difficulty/Difficult to understand/Not at all/Very unacceptable/Very dissatisfied/Not useful/Very unlikely" to 5 "Very Easy/Easy to understand/Very much/ Very acceptable/Very satisfied/Very useful/Very likely" and with a total scores range of 7 to 35 with a higher score representing greater participant acceptability. Subjects will be assigned surveys at baseline, 4 weeks, and 6 weeks. Participants will rate the app on the following 5 domains: understandability, enjoyability, ease of use, time required to use the app, and overall satisfaction. Ratings lower than 4/5 will lead to refinements.
10 secondary outcomes
Number of Enrolled Participants who Consented and Completed the Study (Cohort C)
Time frame: 18 months
Number of Enrolled Participants who Consented and Completed the Study (Cohort D)
Time frame: 18 months
Study Retention (Cohort C)
Time frame: 18 months
Study Retention (Cohort D)
Time frame: 18 months
Median assessment score on the system usability scale at 4 weeks (Cohort C)
Time frame: Up to 6 weeks
Median assessment score on the system usability scale at 4 weeks (Cohort D)
Time frame: Up to 6 weeks
Change in Brief Pain Inventory (BPI) Pain Interference Score from Baseline to 4 and 6 Weeks (Cohort C)
Time frame: Up to 6 weeks
Change in BPI Pain Interference Score from Baseline to 4 and 6 Weeks (Cohort D)
Time frame: Up to 6 weeks
Change in BPI Pain Intensity Score from Baseline to 4 and 6 Weeks (Cohort C)
Time frame: Up to 6 weeks
Change in BPI Pain Intensity Score from Baseline to 4 and 6 Weeks (Cohort D)
Time frame: Up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 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. This study is not recruiting at the moment.
Desiree Azizoddine, PsyD 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 STAMP + CBT and Digital Cancer Pain Education Packet in people with Pain and Pain Syndrome, 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?
The sponsor lists 5 inclusion and 10 exclusion criteria. 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: finished, as of the sponsor's last update on 8 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall intervention adherence rate (Cohort C) (time frame: Up to 4 weeks). The study lists 4 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 8 Jul 2026.