MelanomaNCT07660666
Feasibility of an Enhanced Symptom Monitoring and Expedited Subspecialty Care Referral Intervention to Improve Side Effect Management for Patients With Melanoma Receiving an Immune Checkpoint Inhibitor
A study testing Electronic Health Record Review, Internet-Based Intervention and Patient Navigation in people with Melanoma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This clinical trial tests the feasibility of patient reported outcomes monitoring with early, rapid immunotherapy toxicity subspecialty care to improve side effect management for patients with melanoma receiving an immune checkpoint inhibitor. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma
- What is being tested?
- Electronic Health Record Review, Internet-Based Intervention and Patient Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Jun 2029
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PATIENT: Age 18 years or older
- PATIENT: Histologically confirmed diagnosis of melanoma
- PATIENT: Plan to begin a standard of care (SOC) immune checkpoint inhibitor (ICI) for the treatment of melanoma per Food and Drug Administration (FDA) approval and/or National Comprehensive Cancer Network (NCCN) guidelines
- PATIENT: Willing and able to provide informed consent
- CAREGIVER: Age 18 years or older
- CAREGIVER: Family member or primary caregiver of a study participant
Who cannot join
- PATIENT: Previously received ICI therapy
- PATIENT: Life expectancy of < 6 months at time of enrollment
- PATIENT: Concurrently receiving a non-ICI systemic therapy
- PATIENT: Concurrently receiving radiation, unless hypofractionated palliative radiation prescribed to alleviate poorly controlled symptoms (e.g., pain)
- PATIENT: Needs to rely on a proxy to complete patient-reported outcome instruments
- PATIENT: Unwilling or unable to complete surveys electronically
- CAREGIVER: Needs to rely on a proxy to complete survey instrument(s)
- CAREGIVER: Unwilling or unable to complete surveys electronically
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
OHSU Knight Cancer Institute
Portland, Oregon, 97239
Deanne Tibbitts, 503-494-4361, tibbitts@ohsu.edu
Deanne Tibbitts
About this study
Official title: EMPOWER: Enhancing Melanoma Care Through Patient-Reported Outcomes Monitoring With Early, Rapid Immunotherapy Toxicity Subspecialty Care
This clinical trial tests the feasibility of patient reported outcomes monitoring with early, rapid immunotherapy toxicity subspecialty care to improve side effect management for patients with melanoma receiving an immune checkpoint inhibitor. Immune checkpoint inhibitors have improved outcomes for patients with advanced melanoma, but their use is frequently complicated by immune related adverse events (irAEs). IrAEs can affect any organ system, range in severity from mild to life threatening, and often require a pause or stopping of immunotherapy treatment. Early identification and management of irAEs may reduce progression to severe toxicity. Electronic patient self reporting of symptoms with ways to support early involvement of non oncology subspecialists may be a feasible way to improve side effect management for patients with melanoma receiving an immune checkpoint inhibitor.
Read the detailed description
PRIMARY OBJECTIVE:
- Determine the feasibility of an electronic patient reported outcome (ePRO)-based symptom monitoring and subspecialty care referral intervention for identifying and managing irAEs in patients with melanoma.
SECONDARY OBJECTIVES:
- Evaluate intervention acceptability for key stakeholders, including patients, caregivers, oncologists, and subspecialists.
II. Describe the preliminary efficacy of the intervention to improve management of irAEs.
OUTLINE:
Patients complete an ePRO assessment, where they rate the frequency and/or severity of symptoms that may indicate a moderate to severe irAE, weekly for 6 months. If a patient rates a symptom at a frequency or severity level of moderate or higher, a care provider is notified and determines if the symptoms warrant evaluation by a non-oncology subspecialist or can be managed by medical oncology. Patients receive a referral to an appropriate subspecialist, complete an evaluation of the suspected irAE, within 14 days of the referral, and receive standard of care treatment. Patients may optionally have their caregiver enroll to complete an intervention acceptability survey.
- Conditions
- Melanoma
- Being tested
- Electronic Health Record Review, Internet-Based Intervention, Patient Navigation, Survey Administration
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record ReviewOther
Ancillary studies
Internet-Based InterventionOther
Receive access to ePRO tool
Patient NavigationBehavioural
Also called Patient Navigator Program
Receive review of symptoms and referral if needed
Survey AdministrationOther
Complete ePRO assessments
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (ePRO monitoring and referrals) | Experimental | Patients complete an ePRO assessment, where they rate the frequency and/or severity of symptoms that may indicate a moderate to severe irAE, weekly for 6 months. If a patient rates a symptom at a frequency or severity level of moderate or higher, a care provider is notified and determines if the symptoms warrant evaluation by a non-oncology subspecialist or can be managed by medical oncology. Patients receive a referral to an appropriate subspecialist, complete an evaluation of the suspected irAE, within 14 days of the referral, and receive standard of care treatment. Receives: Other: Electronic Health Record Review; Other: Internet-Based Intervention; Behavioral: Patient Navigation; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eligible patients who consent to the study and begin the intervention (feasibility of study enrollment)
Will estimate the proportion of patients enrolled with 95% confidence intervals.
Measured: At enrollment
Proportion of patients evaluated by subspecialists in ≤ 14 days among participants who enrolled and developed a suspected immune related adverse events (irAE) (grade 2 or higher) (feasibility of intervention delivery)
Measured: From baseline to 6 months
Secondary outcomes (5)
Proportion of patients who complete data collection at 6 months (retention)
Will estimate the proportion of patients retained in the study and adherent to electronic patient reported outcomes with 95% confidence intervals.
Measured: At month 6
Proportion of weeks a Patient Reported Outcome-Common Terminology Criteria for Adverse Events questionnaire was completed out of the number of weeks since starting the intervention (ePRO adherence)
Measured: From baseline to 6 months
Proportion of participants rating the study as acceptable (acceptability)
Assessed via adapted from Basch et al's survey. Acceptability is defined as a mean summary score of 3 or higher.
Measured: At 6 months
Proportion of caregivers for enrolled participants rate the study as acceptable (acceptability)
Assessed via adapted from Basch et al's survey. Acceptability is defined as a mean summary score of 3 or higher.
Measured: At 6 months
Proportion of medical oncologists/subspecialists rate the study as acceptable (acceptability)
Assessed via clinician experience measure.
Measured: At end of the study, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by OHSU Knight 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deanne Tibbitts, OHSU Knight Cancer Institute
- Investigators
- Deanne Tibbitts, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660666
- Sponsor's protocol ID
- STUDY00029559
- Other IDs
- HT9425261E218, NCI-2026-03934, STUDY00029559
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMPOWER: Enhancing Melanoma Care Through Patient-Reported Outcomes Monitoring With Early, Rapid Immunotherapy Toxicity Subspecialty Care
- ClinicalTrials.gov ID
- NCT07660666
- Acronym / sponsor ID
- STUDY00029559
- Conditions
- Melanoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 22 Jun 2026 (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.
This clinical trial tests the feasibility of patient reported outcomes monitoring with early, rapid immunotherapy toxicity subspecialty care to improve side effect management for patients with melanoma receiving an immune checkpoint inhibitor. Immune checkpoint inhibitors have improved outcomes for patients with advanced melanoma, but their use is frequently complicated by immune related adverse events (irAEs). IrAEs can affect any organ system, range in severity from mild to life threatening, and often require a pause or stopping of immunotherapy treatment. Early identification and management of irAEs may reduce progression to severe toxicity. Electronic patient self reporting of symptoms with ways to support early involvement of non oncology subspecialists may be a feasible way to improve side effect management for patients with melanoma receiving an immune checkpoint inhibitor.
Detailed description
PRIMARY OBJECTIVE:
- Determine the feasibility of an electronic patient reported outcome (ePRO)-based symptom monitoring and subspecialty care referral intervention for identifying and managing irAEs in patients with melanoma.
SECONDARY OBJECTIVES:
- Evaluate intervention acceptability for key stakeholders, including patients, caregivers, oncologists, and subspecialists.
II. Describe the preliminary efficacy of the intervention to improve management of irAEs.
OUTLINE:
Patients complete an ePRO assessment, where they rate the frequency and/or severity of symptoms that may indicate a moderate to severe irAE, weekly for 6 months. If a patient rates a symptom at a frequency or severity level of moderate or higher, a care provider is notified and determines if the symptoms warrant evaluation by a non-oncology subspecialist or can be managed by medical oncology. Patients receive a referral to an appropriate subspecialist, complete an evaluation of the suspected irAE, within 14 days of the referral, and receive standard of care treatment. Patients may optionally have their caregiver enroll to complete an intervention acceptability survey.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (ePRO monitoring and referrals) | Experimental | Other: Electronic Health Record Review, Other: Internet-Based Intervention, Behavioral: Patient Navigation, Other: Survey AdministrationPatients complete an ePRO assessment, where they rate the frequency and/or severity of symptoms that may indicate a moderate to severe irAE, weekly for 6 months. If a patient rates a symptom at a frequency or severity level of moderate or higher, a care provider is notified and determines if the symptoms warrant evaluation by a non-oncology subspecialist or can be managed by medical oncology. Patients receive a referral to an appropriate subspecialist, complete an evaluation of the suspected irAE, within 14 days of the referral, and receive standard of care treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- PATIENT: Age 18 years or older
- PATIENT: Histologically confirmed diagnosis of melanoma
- PATIENT: Plan to begin a standard of care (SOC) immune checkpoint inhibitor (ICI) for the treatment of melanoma per Food and Drug Administration (FDA) approval and/or National Comprehensive Cancer Network (NCCN) guidelines
- PATIENT: Willing and able to provide informed consent
- CAREGIVER: Age 18 years or older
Key exclusion criteria (8 listed)
- PATIENT: Previously received ICI therapy
- PATIENT: Life expectancy of < 6 months at time of enrollment
- PATIENT: Concurrently receiving a non-ICI systemic therapy
- PATIENT: Concurrently receiving radiation, unless hypofractionated palliative radiation prescribed to alleviate poorly controlled symptoms (e.g., pain)
- PATIENT: Needs to rely on a proxy to complete patient-reported outcome instruments
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 |
|---|---|---|
| Electronic Health Record ReviewAncillary studies | Other | Supportive care (ePRO monitoring and referrals) |
| Internet-Based InterventionReceive access to ePRO tool | Other | Supportive care (ePRO monitoring and referrals) |
| Patient NavigationAlso: Patient Navigator ProgramReceive review of symptoms and referral if needed | Behavioural | Supportive care (ePRO monitoring and referrals) |
| Survey AdministrationComplete ePRO assessments | Other | Supportive care (ePRO monitoring and referrals) |
| Survey AdministrationAncillary studies | Other | Supportive care (ePRO monitoring and referrals) |
Primary outcome
Proportion of eligible patients who consent to the study and begin the intervention (feasibility of study enrollment)
Time frame: At enrollment
Will estimate the proportion of patients enrolled with 95% confidence intervals.
Proportion of patients evaluated by subspecialists in ≤ 14 days among participants who enrolled and developed a suspected immune related adverse events (irAE) (grade 2 or higher) (feasibility of intervention delivery)
Time frame: From baseline to 6 months
5 secondary outcomes
Proportion of patients who complete data collection at 6 months (retention)
Time frame: At month 6
Proportion of weeks a Patient Reported Outcome-Common Terminology Criteria for Adverse Events questionnaire was completed out of the number of weeks since starting the intervention (ePRO adherence)
Time frame: From baseline to 6 months
Proportion of participants rating the study as acceptable (acceptability)
Time frame: At 6 months
Proportion of caregivers for enrolled participants rate the study as acceptable (acceptability)
Time frame: At 6 months
Proportion of medical oncologists/subspecialists rate the study as acceptable (acceptability)
Time frame: At end of the study, up to 3 years
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 22 Jun 2026.
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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.
Deanne Tibbitts principal investigator
OHSU Knight 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 Electronic Health Record Review, Internet-Based Intervention and Patient Navigation in people with Melanoma, run by OHSU Knight 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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 22 Jun 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of eligible patients who consent to the study and begin the intervention (feasibility of study enrollment) (time frame: At enrollment). 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 22 Jun 2026.