Symptom Management to Improve Completion of Patient-reported Outcome Measures

Conditions

• Malignant Head and Neck Neoplasm
• Malignant Lung Neoplasm
• Malignant Solid Neoplasm

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Monitoring of PROMIS symptoms and physical function — BEHAVIORAL
  Patients will be offered to complete 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-management — BEHAVIORAL
  Assessments of additional symptoms from the PRO-CTCAE will be offered via CIAS. For elevated symptoms, patients will be directed to use evidence-based self-management strategies from the printed Symptom Management Toolkit.

Study Details

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.

Key Dates

First listed

Jul 23, 2026

Start date

Oct 1, 2027

Status verified

Jul 2026

Primary completion

Apr 1, 2031

Completion

Sep 1, 2031

Study Design

Enrollment

78 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Active Comparator: Arm I (PROMIS assessment)
  Patients will be invited to complete 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 PROs assessment completion, we will send them a "Thank You" message acknowledging their completion.
• Experimental: Arm II (PROMIS assessment, PRO-CTCAE assessments, self-management strategies)
  Patients will receive SMS via CIAS and invited to complete the additional PRO-CTCAE items for 9 prevalent symptoms not covered by the PROMIS assessments. These SMS messages will go out on the same schedule as invitations from MyChart to complete PROMIS assessments. When patients complete the PROs 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 SMS 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.

Primary Outcome Measure

Reach of PRO assessment completion [ Time Frame: 6 months ]

Central Contacts

• Eric Adjei Boakye, PhD
  313-874-6218
  [email protected]

Locations (1)

Find similar trials in Detroit, MI

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