N/A
N=104
Improving Cancer On-treatment Symptom Management
Cancer · Thoracic Neoplasms · Gastrointestinal Cancer · Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04589247 ↗Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Participants With Change in Their Physician-assessed Burden Score — 43; 32; 25 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Change in Their Physician-assessed Burden Score |
43; 32; 25 | — |
| SECONDARY Participants With Changes in the Management of On-treatment Symptoms |
29; 39; 19 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04589247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.