Measuring Patient-Reported Outcomes Related to Radiopharmaceuticals for Prostate Cancer
Abstract
Radiotherapeutics (RPT) are a promising new treatment option for men with advanced prostate cancer. RPT work differently than usual chemotherapy and radiation. Most RPT drugs have two molecules: one molecule detects and attaches to prostate cancer cells and the second molecule kills the cancer cells. Another RPT drug, radium-223, has one molecule that travels to bone and kills prostate cancer cells there. Some RPT drugs are approved for use in Europe and Australia. Food and Drug Administration (FDA) approval in the United States is expected soon for these drugs. Because RPT drugs work differently than chemotherapy and radiation, they have different side effects. Common side effects reported by the doctors who have tested these drugs in clinical trials include dry mouth, fatigue, nausea, vomiting, and low white blood cell count. There is very little information about side effects reported by patients, or patient-reported outcomes (PROs). PROs are defined by the FDA as “any report of the health status of a patient that comes directly from the patient, without interpretation by a clinician or anyone else.” PROs provide important information about the patient experience. PROs give different information than side effects reported by doctors. Studies are need to provide high-quality PRO data to patients starting RPT and their families about what to expect during treatment. When high-quality PRO data are not available, patients and their families often search social media and the Internet for information about what to expect during cancer treatment. This information may be untrustworthy. It may not be correct or not apply to them. Because RPT drugs are new, we do not know what questions to ask patients about RPT. It is important to ask the right questions about RPT to make sure we understand the patient experience fully and correctly. The goal of the current Idea Development Award is to create a PRO questionnaire for RPT that can be used in future clinical trials, other studies, and clinical care of prostate cancer patients. The Idea Development Award has four aims. In Aim 1, we will conduct qualitative analyses of the only published PRO data in any prostate cancer population receiving RPTs. We will use these data to help identify the subset of side effects that are particularly likely to be reported by prostate cancer patients receiving RPT. We will also collect qualitative data in interviews with 20 RPT patients, 20 family members, and 10 doctors to find out what questions we should ask and make the new survey. In Aim 2, we will ask 150 patients treated with different RPTs to answer the questions in our item bank. We will use the data to select the final items for the questionnaire. We will make sure the questionnaire is valid, which means we want to know that it is asking what it is intended to ask. We will make sure the questionnaire is reliable, which means patients complete the questionnaire a similar way each time they fill it out. In Aim 2, we will also use questionnaire data to show how PROs change over time in the first 6 months after starting RPT. In Aim 3 we will compare PROs between patients receiving different types of RPTs. Finally, in Aim 4, we will compare PROs in patients receiving different dosage (i.e., dosimetry) of RPTs. This Idea Development Award is innovative and impactful. It is innovative because it looks at a new treatment for prostate cancer from a fresh perspective, the patient’s perspective. It is very different from other studies because there are no existing questionnaires for PROs of RPT. The Idea Development Award is impactful because it addresses one of the FY19 PCRP Overarching Challenges, improving quality of life for survivors of prostate cancer. The questionnaire will have short-term impact. With better information of patient-reported side effects of RPT, doctors can help their patients feel better during treatment. The questionnaire will also have long
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Mar 10, 2021
- Source ID
- W81XWH2010351
Entities
People
- Brian Gonzalez
Organizations
- H. Lee Moffitt Cancer Center & Research Institute
- United States Army