NCT07723495Not yet recruiting
Symptom Management to Improve Completion of Patient-reported Outcome Measures
Promoting Patient Reporting of Outcome Measures Through Technology Integrated Self-management and Engagement (PROMISE)
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- First submitted
- 20 Jul 2026
- Start date
- 1 Oct 2027
- Primary completion date
- 1 Apr 2031
- Lead sponsor
- Henry Ford Health System
- Diseases
- Head and neck cancer, Lung cancer
- NCT number
- NCT07723495
What you commit to
- Study type: Interventional
- Planned participants: 78
- From 1 Oct 2027 to the primary completion date, 1 Apr 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 1\) Unable to read and understand English.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Henry Ford Health Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.