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NCT Number: NCT04589247

Improving Cancer 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.

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Key information

Conditions

Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bayview Medical Center, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Participants With Change in Their Physician-assessed Burden Score

    Time frame: Up to 2 months

    The primary outcome is patients with any change in physicians-assessed burden scores for at least one radiotherapy on-treatment visit. 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. A 2-point score change correlates to a change to the next anchored score (i.e., mild to moderate, 2 to 4; or moderate to severe, 4 to 6)

Secondary outcomes

  1. Participants With Changes in the Management of On-treatment Symptoms

    Time frame: Up to 2 months

    During weekly on-treatment visits and prior to reviewing the patient's PROMs, physicians will formulate an initial symptom management plan based on available clinical data. After reviewing the patient's PROMs, physicians will report participants with changes in recommended interventions due to review of the PROMs.

Other outcomes

  1. Management Changes as Assessed by a Clinician Feedback Form

    Time frame: Up to 2 months

    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.

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • WellSpan Health

Registry information

Official study title

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

Acronym: IMPROVE

Important dates

Study start
2020
Primary completion
2023
Study completion
2025
First posted
Oct 19, 2020
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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