Improving Cancer Symptom Management

Active, not recruiting

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

• Registration Number: NCT04589247
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-10-14
• Study First Posted: 2020-10-19
• Study Start: 2020-11-16
• Primary Completion: 2023-07-07
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-12
• Last Update Posted: 2024-07-16
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants with change in their physician-assessed burden score	Up to 2 months	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.

Trial Locations

Locations (4)

Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States

Khinh Voong; 🇺🇸 Baltimore, Maryland, United States

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center; 🇺🇸 Baltimore, Maryland, United States

Suburban Hospital; 🇺🇸 Bethesda, Maryland, United States