Lung Cancer Clinical Trial

Improving Cancer Symptom Management

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.

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Full 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.

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Eligibility Criteria

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 is for people with:

Lung Cancer

Estimated Enrollment:

100

Study ID:

NCT04589247

Recruitment Status:

Active, not recruiting

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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There are 4 Locations for this study

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Bayview Medical Center
Baltimore Maryland, 21227, United States
Khinh Voong
Baltimore Maryland, 21230, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore Maryland, 21231, United States
Suburban Hospital
Bethesda Maryland, 20814, United States

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Study is for people with:

Lung Cancer

Estimated Enrollment:

100

Study ID:

NCT04589247

Recruitment Status:

Active, not recruiting

Sponsor:


Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

How clear is this clinincal trial information?

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