Clinical trial NCT04589247: Improving Cancer Symptom Management
Official title: Improving Cancer Care by Incorporating the Patient's Voice Into On-treatment Symptom Management
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer
Thoracic Neoplasms
Gastrointestinal Cancer
Lung Cancer
Keywords: Patient Reported Outcomes
Radiotherapy
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: WellSpan Health
First posted: 2020-10-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our study population will be treating radiation oncologists and their primary cancer patients requiring definitive treatment with radiation with or without concurrent chemotherapy as per the inclusion criteria below. Cancer patients receiving stereotactic body radiation therapy or hypo-fractionated definitive radiation will not be recruited as these patients represent a different treatment population with a much lower overall treatment toxicity burden.

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Proportion of participants with change in their physician-assessed burden score
timeFrame: Up to 2 months
Secondary outcomes:
Other outcomes:
measure: Proportion of participants with changes in the management of on-treatment symptoms
timeFrame: Up to 2 months
measure: Management changes as assessed by a Clinician Feedback Form
timeFrame: Up to 2 months
Locations:
city: Baltimore
country: United States
facility: Bayview Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Khinh Voong
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Bethesda
country: United States
facility: Suburban Hospital
state: Maryland
Study officials:
affiliation: SKCCC at Johns hopkins
name: Ranh Voong, MD
role: PRINCIPAL_INVESTIGATOR
References: