Cancer Clinical Trial
— IMPROVEOfficial title:
Improving Cancer Care by Incorporating the Patient's Voice Into On-treatment Symptom Management
Verified date | June 2024 |
Source | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | June 2025 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | |
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | WellSpan Health |
United States,
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 |
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