Improving Cancer Symptom Management (IMPROVE)

Improving Cancer Care by Incorporating the Patient's Voice Into On-treatment Symptom Management

Patient-reported outcome measures (PROMs) is an umbrella term that refers to any report on a health status measure that is reported directly by the patient, without the influence of clinicians or anyone else. PROMs have been shown to more closely reflect a patient's daily health status when compared to physician-reported measures. However, research is needed to evaluate if patient symptom reporting during definitive-intent radiotherapy allows earlier and improved detection of treatment toxicity.

The IMPROVE pilot study will describe the proportion of patients with cancer with changes in physician-perception of treatment-related toxicity that result from routine physician review of PROMs reported during definitive radiotherapy.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Thoracic Neoplasms; Lung Cancer; Gastrointestinal Cancer

Detailed Description

Patient-reported outcome measures (PROMs) is an umbrella term that refers to any report on a health status measure that is reported directly by the patient, without the influence of clinicians or anyone else. PROMs have been shown to more closely reflect a patient's daily health status when compared to physician-reported measures. However, research is needed to evaluate if patient symptom reporting during definitive-intent radiotherapy allows earlier and improved detection of treatment toxicity, and leads to individualized interventions which may improve the toxicity outcomes for patients with locally-advanced and oligometastatic cancer.

The investigators hypothesize that routine physician review of PROMs during on-treatment visits will (1) increase proportion of patients with an increased in their physician' s assessment of their overall toxicity burden during definitive radiotherapy, and (2) correspondingly increase the proportion of patients receiving physician-directed interventions for treatment-related symptoms.

The IMPROVE pilot study will describe the proportion of patients with cancer with changes in physician-perception of treatment-related toxicity that result from routine physician review of PROMs reported during definitive radiotherapy. The IMPROVE study will also describe (1) the proportion of patients with changes in the management of treatment-related symptoms and (2) the type of management changes that result from routine physician review of PROMs reported during definitive radiotherapy.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Ranh Voong, MD; Phone Number: 4105506597; Email: kvoong1@jhmi.edu
• Study Contact Backup: Name: Dana Kaplin, MPH; Phone Number: 4106143950; Email: dkaplin1@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Recruiting
      • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
      • Contact: Khinh Voong, MD; Phone Number: 410-550-6597; Email: kvoong1@jhmi.edu
    • Baltimore, Maryland, United States, 21227
      • Recruiting
      • Bayview Medical Center
      • Contact: Khinh Voong, M.D.; Phone Number: 410-550-6597
    • Baltimore, Maryland, United States, 21230
      • Not yet recruiting
      • Khinh Voong
      • Contact: Khinh Voong, MD; Phone Number: 410-550-6597; Email: jwrigh71@jhmi.edu
    • Bethesda, Maryland, United States, 20814
      • Not yet recruiting
      • Suburban Hospital
      • Contact: Stephen Greco, M.D.; Phone Number: 866-476-1224

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Our study population will be treating radiation oncologists and their primary cancer patients requiring definitive treatment with radiation with or without concurrent chemotherapy as per the inclusion criteria below. Cancer patients receiving stereotactic body radiation therapy or hypo-fractionated definitive radiation will not be recruited as these patients represent a different treatment population with a much lower overall treatment toxicity burden.

Description

Inclusion Criteria:

• Men and women over 18 years of age
• Able to read and write in English or able to understand/answer questions with the aid of an interpreter
• Histologically confirmed loco-regional to advanced primary cancer, including but not limited to lung cancer, esophageal, or gastro-intestinal cancers at risk of developing radiotherapy-related toxicity.
• Receiving definitive conventionally-fractionated radiation treatment with or without chemotherapy

Exclusion Criteria:

• Patients receiving radiation for palliative intent
• Patients who do not provide informed consent
• Patients who chose to withdraw from the study

Radiation Oncologists

Inclusion criteria:

• Must be the physician overseeing the care of the patient who answers the PROMS

Exclusion criteria:

• Have not provided informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with cancer treated with definitive-intent radiotherapy; Histologically confirmed loco-regional to advanced primary cancer, including but not limited to lung cancer, esophageal, or gastro-intestinal cancers at risk of developing radiotherapy-related toxicity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with change in their physician-assessed burden score	The primary outcome is the proportion of patients with any change in their physicians-assessed burden scores for at least one radiotherapy on-treatment visit, along with their exact binomial 95% confidence interval. Lee et al. demonstrated the feasibility of using a global burden score to capture the provider's overall perception of the combined burden of all assessed symptoms, using a visual analogue scale demarcating an aggregate score from 0 to 10. This scale uses anchors at 0, 2, 4, 6, 8, and 10 for no, mild, moderate, severe, life-threatening adverse events, and death, respectively.	Up to 2 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with changes in the management of on-treatment symptoms	During weekly on-treatment visits and prior to reviewing their patient's PROMs, physicians will formulate an initial symptom management plan based on available clinical data. Then after reviewing the patient's PROMs, physicians will report any change in recommended interventions due to review of the PROMs.	Up to 2 months
Management changes as assessed by a Clinician Feedback Form	At the end of each patient's course of radiotherapy, providers will complete a Clinician Feedback Form that details the types of new management interventions resulting from routine review of the PROMs over the course of definitive radiation.	Up to 2 months

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: WellSpan Health
• Investigators: Principal Investigator: Ranh Voong, MD, SKCCC at Johns Hopkins

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2020
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 14, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Radiotherapy; Patient Reported Outcomes
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Thoracic Neoplasms
• Other Study ID Numbers: J2048

Drug and device information, study documents

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