Improving Cancer On-treatment Symptom Management (IMPROVE)

Johns Hopkins Medicine

Status: Completed

Conditions: Thoracic Neoplasms; Gastrointestinal Cancer; Lung Cancer; Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT04589247

J2048

IRB00218263 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

104 participants in 1 patient group

Patients with cancer treated with definitive-intent radiotherapy

Description:

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.