Symptom Management to Improve Completion of Patient-reported Outcome Measures

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Malignant Solid Neoplasm; Malignant Head and Neck Neoplasm; Malignant Lung Neoplasm
• Intervention / Treatment: Behavioral: Monitoring of PROMIS symptoms and physical function; Behavioral: Monitoring of additional symptoms and symptom self-management

Detailed Description

PRIMARY OBJECTIVE:

1. 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:

1. 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).
2. 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 Type: Interventional
• Enrollment (Estimated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric Adjei Boakye, PhD; Phone Number: 313-874-6218; Email: eadjei1@hfhs.org

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health
      • Contact: Eric Adjei Boakye, PhD; Phone Number: (313) 874-6218; Email: eadjei1@hfhs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion 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).

Exclusion Criteria:

• 1) Unable to read and understand English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I (PROMIS assessment); 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.	Behavioral: Monitoring of PROMIS symptoms and physical function; 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.
Experimental: Arm II (PROMIS assessment, PRO-CTCAE assessments, self-management strategies); 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.	Behavioral: Monitoring of PROMIS symptoms and physical function; 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.; Behavioral: Monitoring of additional symptoms and symptom self-management; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach of patient reported outcome (PRO) assessment completion	The number of completed Patient-Reported Outcomes Measurement Information System (PROMIS) assessments over 6 months.	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.	6 months

Collaborators and Investigators

• Sponsor: Henry Ford Health System

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2027
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): September 1, 2031

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 29, 2026
• Last Update Submitted That Met QC Criteria: July 28, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Symptom management; Patient-reported outcomes
• Additional Relevant MeSH Terms: Neoplasms by Site; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms; Lung Neoplasms; Head and Neck Neoplasms; Public Health; Environment and Public Health; Health Services; Health Care Facilities Workforce and Services; Rehabilitation; Health Status; Demography; Epidemiologic Measurements; Activities of Daily Living; Functional Status
• Other Study ID Numbers: 19934; K01CA308852-01A1 (Other Identifier: NCI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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).
• IPD Sharing Time Frame: Data will be available after study investigators have publicly presented and published key findings, anticipated beginnings from 06/01/2033 for 5 years, until 05/31/2038.
• IPD Sharing Access Criteria: Data from this study will be available to other researchers upon request to the principal investigator and under the following conditions: 1) appropriate human subjects protection is in place; 2) data have been de-identified; and 3) study investigators have publicly presented and published key findings.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No