Improving Cancer Symptom Management

Cancer Clinical Trial

— IMPROVE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04589247
• Other study ID #: J2048
• Secondary ID: IRB00218263
• Status: Active, not recruiting
• Start date: November 16, 2020
• Est. completion date: June 2025

Study information

• Verified date: June 2024
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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, 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Lung Cancer
• Thoracic Neoplasms

Locations

Country	Name	City	State
United States	Bayview Medical Center	Baltimore	Maryland
United States	Johns Hopkins Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland
United States	Khinh Voong	Baltimore	Maryland
United States	Suburban Hospital	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	WellSpan Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of participants with changes in the management of on-treatment symptoms	During weekly on-treatment visits and prior to reviewing their patient's PROMs, physicians will formulate an initial symptom management plan based on available clinical data. Then after reviewing the patient's PROMs, physicians will report any change in recommended interventions due to review of the PROMs.	Up to 2 months
Other	Management changes as assessed by a Clinician Feedback Form	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.	Up to 2 months
Primary	Proportion of participants with change in their physician-assessed burden score	The primary outcome is the proportion of patients with any change in their physicians-assessed burden scores for at least one radiotherapy on-treatment visit, along with their exact binomial 95% confidence interval. 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.	Up to 2 months