Symptom Management for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults with head and neck or lung cancer who are about to start, or have just started, infusion therapy. Participants must be able to understand English and be mentally alert.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive systemic therapy for head and neck or lung cancer, with intervention arm receiving additional symptoms monitoring and self-management strategies
Follow-up
Participants are monitored for safety and effectiveness after treatment, focusing on PRO assessment completion and symptom management
What Are the Treatments Tested in This Trial?
Interventions
- Monitoring of additional symptoms and symptom self-management
- Monitoring of PROMIS symptoms and physical function
Trial Overview
The study compares standard symptom monitoring versus extra symptom tracking plus self-care advice sent by text. The goal is to see if more patients complete health surveys when they get extra support managing symptoms during cancer treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Henry Ford Health System
Lead Sponsor
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.