Not Yet RecruitingNot applicableNCT07723495
Official study title

Symptom Management to Improve Completion of Patient-reported Outcome Measures

Study 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 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.

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Key things to know

Main goalSupportive Care

This describes the study’s primary purpose.

What is being studiedMonitoring of PROMIS symptoms and physical function and Monitoring of additional symptoms and symptom self-management

The study team can explain what participation involves.

Who it may be forMalignant Solid Neoplasm · Malignant Head and Neck Neoplasm

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 29, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Not Yet Recruiting

The study is not accepting participants yet.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Henry Ford Health System

Study sponsor

01
Study overview

What this study is about

Purpose
Supportive Care
Study type
Interventional
Phase
Not applicable
Sponsor
Henry Ford Health System
Interventions being studied
Behavioral: Monitoring of PROMIS symptoms and physical function; Behavioral: Monitoring of additional symptoms and symptom self-management
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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).
Reasons someone may not be able to joinExclusion criteria

1\) Unable to read and understand English.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Henry Ford HealthDetroit, Michigan

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 29, 2026. Always confirm current availability with the study team.

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