Trial Outcomes & Findings for Improving Cancer On-treatment Symptom Management (NCT NCT04589247)

Results Overview

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)

Recruitment status

COMPLETED

Target enrollment

104 participants

Primary outcome timeframe

Up to 2 months

Results posted on

2025-09-25

Participant Flow

A total of 104 patients enrolled in the study. Four patients were excluded from the analysis.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	104
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Cancer On-treatment Symptom Management

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Cancer Treated With Definitive-intent Radiotherapy n=100 Participants 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.
Age, Continuous	70 years n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian, non-Hispanic	81 Participants n=5 Participants
Race/Ethnicity, Customized African American	13 Participants n=5 Participants
Race/Ethnicity, Customized Other	6 Participants n=5 Participants
Region of Enrollment United States	100 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Patients With Cancer Treated With Definitive-intent Radiotherapy n=100 Participants 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.
Participants With Change in Their Physician-assessed Burden Score Patients with an increased or decreased burden-score of 1 point.	43 Participants
Participants With Change in Their Physician-assessed Burden Score Patients with an increased or decreased burden-score of ≥ 2 points.	32 Participants
Participants With Change in Their Physician-assessed Burden Score Patients with no change in burden-score.	25 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With Cancer Treated With Definitive-intent Radiotherapy n=100 Participants 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.
Participants With Changes in the Management of On-treatment Symptoms New Medications/ New Interventions	29 Participants
Participants With Changes in the Management of On-treatment Symptoms Counseling/ Modification of Medications	39 Participants
Participants With Changes in the Management of On-treatment Symptoms Referral to Other Services/ Further Tests	19 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Patients With Cancer Treated With Definitive-intent Radiotherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ranh Voong, MD

Johns Hopkins University

Phone: 4105506597

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place