Improving Cancer On-treatment Symptom Management

NCT04589247 | Completed Results

• 2 other identifiers: J2048IRB00218263
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 4

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.

Conditions

Cancer; Thoracic Neoplasms; Gastrointestinal Cancer; Lung Cancer

Keywords

Patient Reported Outcomes; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Participants With Change in Their Physician-assessed Burden Score

  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)

  Up to 2 months

Secondary Outcomes (1)

• Participants With Changes in the Management of On-treatment Symptoms

  Up to 2 months

Other Outcomes (1)

• Management Changes as Assessed by a Clinician Feedback Form

  Up to 2 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients receiving radiation for palliative intent
• Patients who do not provide informed consent
• Patients who chose to withdraw from the study
• Radiation Oncologists
• Must be the physician overseeing the care of the patient who answers the PROMS
• Have not provided informed consent

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• WellSpan Health: collaborator

Study Sites (4)

Bayview Medical Center

Baltimore, Maryland, 21227, United States

Location

Khinh Voong

Baltimore, Maryland, 21230, United States

Location

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

Location

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

MeSH Terms

Conditions

Neoplasms; Thoracic Neoplasms; Gastrointestinal Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Ranh Voong, MD
• Organization: Johns Hopkins University

kvoong1@jhmi.edu

4105506597

Study Officials

• Ranh Voong, MD

  SKCCC at Johns hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 19, 2020
• Study Start: November 16, 2020
• Primary Completion: July 23, 2023
• Study Completion: June 30, 2025
• Last Updated: September 25, 2025
• Results First Posted: September 25, 2025

Record last verified: 2025-09

Locations

US (4)