Malignant Solid NeoplasmNCT07723495
Symptom Management to Improve Completion of Patient-reported Outcome Measures
A study testing Monitoring of PROMIS symptoms and physical function and Monitoring of additional symptoms and symptom self-management in people with Malignant Solid Neoplasm and Malignant Head and Neck Neoplasm, run by Henry Ford Health System at 1 site in United States.
Trial summary
In this clinical trial, patient reported outcome (PRO) assessment completion is compared between patients (undergoing systemic therapy for head and neck or lung cancer) who receive additional symptoms monitoring and evidence-based self-management strategies for those with elevated symptoms (intervention arm), and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Neoplasm, Malignant Head and Neck Neoplasm, Malignant Lung Neoplasm
- What is being tested?
- Monitoring of PROMIS symptoms and physical function and Monitoring of additional symptoms and symptom self-management
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2027to 1 Sep 2031
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Adults (≥18 years) with a diagnosis of a malignancy of head and neck or lung cancers.
- 2) Scheduled to start infusion systemic therapy in the next 4 weeks or have started infusion systemic therapy in the past 4 weeks.
- 3) Able to read and understand English.
- 4) Cognitively oriented to person, place and time (determined by recruiter).
Who cannot join
- 1) Unable to read and understand English.
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
Henry Ford Health
Detroit, Michigan, 48202
Eric Adjei Boakye, PhD, (313) 874-6218, eadjei1@hfhs.org
About this study
Official title: Promoting Patient Reporting of Outcome Measures Through Technology Integrated Self-management and Engagement (PROMISE)
In this clinical trial, patient reported outcome (PRO) assessment completion is compared between patients (undergoing systemic therapy for head and neck or lung cancer) who receive additional symptoms monitoring and evidence-based self-management strategies for those with elevated symptoms (intervention arm), and those who do not receive these (control arm). PRO measures are validated tools that capture health-related perspectives directly from the patient and are complementary to provider assessment. Timely completion of PRO assessments and symptoms management of moderate or severe symptoms are essential to improve quality of life and decrease unwanted health care utilization. However, only ~40% of patients complete PRO assessments in clinical settings. In addition, systemic therapy for cancer results in many symptoms (e.g., dry mouth, shortness of breath, constipation) not covered by the disease-general Patient-Reported Outcomes Measurement Information System (PROMIS) measures. Patients in the control arm will receive the existing PROMIS assessments and a thank you message upon completion. Patients in the intervention arm will receive the PROMIS assessments in addition to nine Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) most prevalent symptoms, and evidence-based self-management strategies Handbook for those with elevated symptoms. Patients in the intervention arm will enter their symptoms in a SMS text and they will be directed to the handbook for strategies to manage their elevated symptoms using a digital platform-Computerized Intervention Authoring System (CIAS)-integrated within the Epic electronic health records. Information gathered has the potential to influence cancer care practices on a larger scale, shaping policies and clinical practices to improve health outcomes for cancer patients and reducing the burden of cancer-related symptoms.
Read the detailed description
PRIMARY OBJECTIVE:
- To test the effectiveness of the intervention's enhanced patient reported outcome (PRO) monitoring strategy (offer of nine Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) most prevalent symptoms and evidence-based self-management strategies for elevated symptoms) versus the active control (receipt of the Patient-Reported Outcomes Measurement Information System (PROMIS) measures) on PRO monitoring reach and penetration [PRO assessment completion] over 6 months.
SECONDARY OBJECTIVES:
- Test the extent to which any differences in PRO monitoring reach and penetration between intervention and control arms at month 6 are explained by patient's symptom management self-efficacy and expectancy at month 3 (potential mechanisms).
- Test the extent to which any differences in PRO monitoring reach and penetration at month 6 between intervention and control arms differ according to patient, disease and treatment characteristics (e.g., age, site and stage of cancer, concurrent radiation therapy).
- Being tested
- Monitoring of PROMIS symptoms and physical function, Monitoring of additional symptoms and symptom self-management
- Keywords
- Cancer, Symptom management, Patient-reported outcomes
- Medical subject headings
- Head and Neck Neoplasms, Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring of PROMIS symptoms and physical functionBehavioural
Patients will be offered to complete Patient-Reported Outcomes Measurement Information System (PROMIS) measures of symptoms and physical function prior to their scheduled clinic appointments via MyChart or on a tablet in the clinic's waiting room. The scores are recorded in their health record and available for review by health care providers.
Monitoring of additional symptoms and symptom self-managementBehavioural
Assessments of additional symptoms from the Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) will be offered via Computerized Intervention Authoring System (CIAS). For elevated symptoms, patients will be directed to use evidence-based self-management strategies from the printed Symptom Management Toolkit.
| Study group | Role | What they receive |
|---|---|---|
| Arm I (PROMIS assessment) | Active comparator | Patients will be invited to complete Patient-Reported Outcomes Measurement Information System (PROMIS) assessments via MyChart. If MyChart assessments are not completed, patients will be asked to complete them on a tablet in the waiting room during clinic visit. Patients receive reminders to complete their eCheck-in and questionnaires including PROMIS 48hrs before their visit. Upon patients-reported outcomes assessment completion, we will send them a "Thank You" message acknowledging their completion. Receives: Behavioral: Monitoring of PROMIS symptoms and physical function |
| Arm II (PROMIS assessment, PRO-CTCAE assessments, self-management strategies) | Experimental | Patients will receive text message via Computerized Intervention Authoring System (CIAS) and invited to complete Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) items for the most prevalent symptoms. When patients complete the patient reported outcomes assessment, we will immediately send them a message acknowledging receipt of symptoms, a summary of symptoms and a thank you message. Patients receive a copy of the Symptom Management Toolkit and when a symptom is rated at 2 or higher in severity (common PRO-CTCAE dimension for 8 symptoms) or if diarrhea is rated at 2 or higher in frequency (the only PRO-CTCAE dimension for this symptom), patients will be sent a follow-up text message directing them to specific relevant sections of the Toolkit. When any symptom is rated at 3 or higher, patients will be asked to contact their healthcare provider about this symptom. Receives: Behavioral: Monitoring of PROMIS symptoms and physical function; Behavioral: Monitoring of additional symptoms and symptom self-management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach of patient reported outcome (PRO) assessment completion
The number of completed Patient-Reported Outcomes Measurement Information System (PROMIS) assessments over 6 months.
Measured: 6 months
Penetration of patient reported outcome (PRO) assessment completion
The percent of completed Patient-Reported Outcomes Measurement Information System (PROMIS) assessments over 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Oct 2027 (estimated)
- Primary completion1 Apr 2031 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Adjei Bokaye, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723495
- Sponsor's protocol ID
- 19934
- Other IDs
- K01CA308852-01A1
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data to be shared include primary outcomes (completion of Patient-Reported Outcomes Measurement Information System (PROMIS) assessments over 6 months), intervention arm, and relevant patient, disease and treatment characteristics (e.g., age, sex, site and stage of cancer, concurrent radiation therapy).
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Patient Reporting of Outcome Measures Through Technology Integrated Self-management and Engagement (PROMISE)
- ClinicalTrials.gov ID
- NCT07723495
- Acronym / sponsor ID
- 19934
- Keywords
- Cancer, Symptom management, Patient-reported outcomes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 1 Oct 2027 (estimated)
- Primary completion
- 1 Apr 2031 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 23 Jul 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.
In this clinical trial, patient reported outcome (PRO) assessment completion is compared between patients (undergoing systemic therapy for head and neck or lung cancer) who receive additional symptoms monitoring and evidence-based self-management strategies for those with elevated symptoms (intervention arm), and those who do not receive these (control arm). PRO measures are validated tools that capture health-related perspectives directly from the patient and are complementary to provider assessment. Timely completion of PRO assessments and symptoms management of moderate or severe symptoms are essential to improve quality of life and decrease unwanted health care utilization. However, only ~40% of patients complete PRO assessments in clinical settings. In addition, systemic therapy for cancer results in many symptoms (e.g., dry mouth, shortness of breath, constipation) not covered by the disease-general Patient-Reported Outcomes Measurement Information System (PROMIS) measures. Patients in the control arm will receive the existing PROMIS assessments and a thank you message upon completion. Patients in the intervention arm will receive the PROMIS assessments in addition to nine Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) most prevalent symptoms, and evidence-based self-management strategies Handbook for those with elevated symptoms. Patients in the intervention arm will enter their symptoms in a SMS text and they will be directed to the handbook for strategies to manage their elevated symptoms using a digital platform-Computerized Intervention Authoring System (CIAS)-integrated within the Epic electronic health records. Information gathered has the potential to influence cancer care practices on a larger scale, shaping policies and clinical practices to improve health outcomes for cancer patients and reducing the burden of cancer-related symptoms.
Detailed description
PRIMARY OBJECTIVE:
- To test the effectiveness of the intervention's enhanced patient reported outcome (PRO) monitoring strategy (offer of nine Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) most prevalent symptoms and evidence-based self-management strategies for elevated symptoms) versus the active control (receipt of the Patient-Reported Outcomes Measurement Information System (PROMIS) measures) on PRO monitoring reach and penetration [PRO assessment completion] over 6 months.
SECONDARY OBJECTIVES:
- Test the extent to which any differences in PRO monitoring reach and penetration between intervention and control arms at month 6 are explained by patient's symptom management self-efficacy and expectancy at month 3 (potential mechanisms).
- Test the extent to which any differences in PRO monitoring reach and penetration at month 6 between intervention and control arms differ according to patient, disease and treatment characteristics (e.g., age, site and stage of cancer, concurrent radiation therapy).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (PROMIS assessment) | Active comparator | Behavioral: Monitoring of PROMIS symptoms and physical functionPatients will be invited to complete Patient-Reported Outcomes Measurement Information System (PROMIS) assessments via MyChart. If MyChart assessments are not completed, patients will be asked to complete them on a tablet in the waiting room during clinic visit. Patients receive reminders to complete their eCheck-in and questionnaires including PROMIS 48hrs before their visit. Upon patients-reported outcomes assessment completion, we will send them a "Thank You" message acknowledging their completion. |
| Arm II (PROMIS assessment, PRO-CTCAE assessments, self-management strategies) | Experimental | Behavioral: Monitoring of PROMIS symptoms and physical function, Behavioral: Monitoring of additional symptoms and symptom self-managementPatients will receive text message via Computerized Intervention Authoring System (CIAS) and invited to complete Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) items for the most prevalent symptoms. When patients complete the patient reported outcomes assessment, we will immediately send them a message acknowledging receipt of symptoms, a summary of symptoms and a thank you message. Patients receive a copy of the Symptom Management Toolkit and when a symptom is rated at 2 or higher in severity (common PRO-CTCAE dimension for 8 symptoms) or if diarrhea is rated at 2 or higher in frequency (the only PRO-CTCAE dimension for this symptom), patients will be sent a follow-up text message directing them to specific relevant sections of the Toolkit. When any symptom is rated at 3 or higher, patients will be asked to contact their healthcare provider about this symptom. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1) Adults (≥18 years) with a diagnosis of a malignancy of head and neck or lung cancers.
- 2) Scheduled to start infusion systemic therapy in the next 4 weeks or have started infusion systemic therapy in the past 4 weeks.
- 3) Able to read and understand English.
- 4) Cognitively oriented to person, place and time (determined by recruiter).
Key exclusion criteria (1 listed)
- 1) Unable to read and understand English.
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 |
|---|---|---|
| Monitoring of PROMIS symptoms and physical functionPatients will be offered to complete Patient-Reported Outcomes Measurement Information System (PROMIS) measures of symptoms and physical function prior to their scheduled clinic appointments via MyChart or on a tablet in the clinic's waiting room. The scores are recorded in their health record and available for review by health care providers. | Behavioural | Arm I (PROMIS assessment), Arm II (PROMIS assessment, PRO-CTCAE assessments, self-management strategies) |
| Monitoring of additional symptoms and symptom self-managementAssessments of additional symptoms from the Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) will be offered via Computerized Intervention Authoring System (CIAS). For elevated symptoms, patients will be directed to use evidence-based self-management strategies from the printed Symptom Management Toolkit. | Behavioural | Arm II (PROMIS assessment, PRO-CTCAE assessments, self-management strategies) |
Primary outcome
Reach of patient reported outcome (PRO) assessment completion
Time frame: 6 months
The number of completed Patient-Reported Outcomes Measurement Information System (PROMIS) assessments over 6 months.
Penetration of patient reported outcome (PRO) assessment completion
Time frame: 6 months
The percent of completed Patient-Reported Outcomes Measurement Information System (PROMIS) assessments over 6 months.
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 29 Jul 2026.
- Individual participant dataSharing planned: Yes. Data to be shared include primary outcomes (completion of Patient-Reported Outcomes Measurement Information System (PROMIS) assessments over 6 months), intervention arm, and relevant patient, disease and treatment characteristics (e.g., age, sex, site and stage of cancer, concurrent radiation therapy).
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring of PROMIS symptoms and physical function and Monitoring of additional symptoms and symptom self-management in people with Malignant Solid Neoplasm and Malignant Head and Neck Neoplasm, run by Henry Ford Health System 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 4 inclusion and 1 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 29 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?
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 Eric Adjei Boakye, PhD (313-874-6218, eadjei1@hfhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach of patient reported outcome (PRO) assessment completion (time frame: 6 months). 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 29 Jul 2026.