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NCT04589247: IMPROVE

Improving Cancer On-treatment Symptom Management

Completed Results posted Last updated 25 September 2025
What this trial tests

trial in Cancer in 104 participants. Completed in 30 June 2025.

Timeline
16 November 2020
Primary endpoint
23 July 2023
30 June 2025

Quick facts

Lead sponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
StatusCompleted
Study typeOBSERVATIONAL
Enrollment104
Start date16 November 2020
Primary completion23 July 2023
Estimated completion30 June 2025
Sites4 locations across United States

Conditions studied

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →

Who can join

Adults 18 to 100, any sex, with Cancer or Thoracic Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Participants With Change in Their Physician-assessed Burden Score Primary · 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 t

Patients with an increased or decreased burden-score of 1 point.
GroupValue95% CI
Patients With Cancer Treated With Definitive-intent Radiotherapy43
Patients with an increased or decreased burden-score of ≥ 2 points.
GroupValue95% CI
Patients With Cancer Treated With Definitive-intent Radiotherapy32
Patients with no change in burden-score.
GroupValue95% CI
Patients With Cancer Treated With Definitive-intent Radiotherapy25
Participants With Changes in the Management of On-treatment Symptoms Secondary · 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.

New Medications/ New Interventions
GroupValue95% CI
Patients With Cancer Treated With Definitive-intent Radiotherapy29
Counseling/ Modification of Medications
GroupValue95% CI
Patients With Cancer Treated With Definitive-intent Radiotherapy39
Referral to Other Services/ Further Tests
GroupValue95% CI
Patients With Cancer Treated With Definitive-intent Radiotherapy19

Sponsor's own 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. 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Cancer

Currently open trials in the same condition.

Other Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04589247.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing