Symptom Management for Cancer

EA
Overseen ByEric Adjei Boakye, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Henry Ford Health System
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

I am 18 or older and have head, neck, or lung cancer.
I am aware of who I am, where I am, and what day it is.
I am about to start or have just started infusion systemic therapy within 4 weeks.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive systemic therapy for head and neck or lung cancer, with intervention arm receiving additional symptoms monitoring and self-management strategies

6 months
Regular visits as per systemic therapy schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on PRO assessment completion and symptom management

4 weeks

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

Group I: Arm II (PROMIS assessment, PRO-CTCAE assessments, self-management strategies)Experimental Treatment2 Interventions
Group II: Arm I (PROMIS assessment)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials
334
Recruited
2,197,000+