IMPROVE: Improving Cancer Symptom Management
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Outcome Measures
Primary Outcome Measures
- Proportion of participants with change in their physician-assessed burden score [Up to 2 months]
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.
Other Outcome Measures
- Proportion of participants with changes in the management of on-treatment symptoms [Up to 2 months]
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.
- Management changes as assessed by a Clinician Feedback Form [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Men and women over 18 years of age
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Able to read and write in English or able to understand/answer questions with the aid of an interpreter
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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.
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Receiving definitive conventionally-fractionated radiation treatment with or without chemotherapy
Exclusion Criteria:
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Patients receiving radiation for palliative intent
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Patients who do not provide informed consent
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bayview Medical Center | Baltimore | Maryland | United States | 21227 |
| 2 | Khinh Voong | Baltimore | Maryland | United States | 21230 |
| 3 | Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | United States | 21231 |
| 4 | Suburban Hospital | Bethesda | Maryland | United States | 20814 |
Sponsors and Collaborators
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- WellSpan Health
Investigators
- Principal Investigator: Ranh Voong, MD, SKCCC at Johns hopkins
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- J2048