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What was the project about?

Patient-reported outcome measures, or PROMs, ask patients how they feel and what activities they can do in daily life. Patients receiving cancer treatment, such as chemotherapy, often have side effects. PROMs can help cancer centers know if patients are getting high-quality care that helps manage their side effects.

In this study, the research team wanted to

• Learn from patients and clinicians, like doctors and nurses, what side effects are important to track during chemotherapy
• Create PROMs that can measure important side effects of chemotherapy

The research team also wanted to test the PROMs to see

• If patients find them easy to complete
• If the PROMs can detect differences in how well cancer centers control patients’ treatment side effects

What did the research team do?

First, the research team interviewed 124 patients, caregivers, clinicians, and healthcare administrators at six cancer centers. The cancer centers were in California, Connecticut, Florida, Minnesota, North Carolina, and Texas. The team asked which side effects from chemotherapy are most important to track.

Next, the research team reviewed existing PROMs that measure the side effects the group found important. Using PROMs found through the review, the team created 12 new PROMs.

The research team then tested a survey that included the new PROMs. The survey also asked if the PROMs were easy to complete and understand. Patients took the survey at home, online, or by phone after they started chemotherapy.

A total of 607 patients completed the survey. Of these, 73 percent were White, 14 percent were African American, 8 percent were Asian, and 5 percent were another race; 11 percent were Hispanic. Also, 62 percent of patients were under age 65, and 51 percent were women. All patients received care at the six cancer centers.

Patients, clinicians, and PROM researchers helped design the study and analyze results.

What were the results?

From the interviews, the most important side effects were pain, fatigue, and nausea and vomiting.

In filling out the survey

• Ninety-six percent of patients said that the PROMs were easy to complete
• Ninety-seven percent said that the PROMs were easy to understand
• Seventy-two percent completed the survey without a reminder call, and 14 percent completed the survey after a reminder call

The PROMs detected differences between centers. Based on the 12 PROMs, one cancer center performed better than others, and one performed worse. However, not enough patients completed the survey to consistently compare the quality of care across cancer centers.

What were the limits of the project?

The study did not include enough patients to consistently compare quality across cancer centers. Future research could test the PROMS with more patients at different cancer centers.

How can people use the results?

Cancer centers can use these results when considering how to assess patients’ side effects during chemotherapy.

Background

Patient-reported outcome measures (PROMs) are used to assess the quality of care in many medical fields. PROMs may be useful in evaluating the quality of care patients with cancer receive by assessing control of chemotherapy side effects. However, researchers have not yet developed PROMs that assess side effects of chemotherapy.

Objective

To develop and test the feasibility, acceptability, practice-level differences, and risk adjustment of PROMs that capture patient-reported levels of chemotherapy side effects

Study Design

Methods and Results

Researchers first interviewed 124 patients, caregivers, clinicians, and healthcare administrators at six cancer centers in California, Connecticut, Florida, Minnesota, North Carolina, and Texas to identify side effects of chemotherapy that are important to patients. Side effects including pain, fatigue, and nausea and vomiting were of greatest concern.

Researchers next reviewed the literature to identify existing PROMs that assess the side effects found in the interviews. Using these PROMs, researchers developed 12 single-item PROMs to track patient-reported levels of side effects from chemotherapy treatment, like pain, neuropathy, diarrhea, fatigue, anxiety, and others. Researchers also created summary measures made up of multiple single-item measures.

Finally, the research team fielded a survey with the new PROMs. A total of 607 patients receiving care from the six cancer centers completed the survey, which also included questions about ease of completion and understanding of PROMs. Patients completed the survey at home, online, or by phone, between 5 and 15 days after the start of chemotherapy.

Of the surveyed patients, 73% were White, 14% were African American, 8% were Asian, and 5% were another race; 11% were Hispanic. Also, 62% of patients were under age 65, and 51% were female.

Patients, clinicians, and PROM researchers helped design the study and analyze results.

In responding to the survey

• Ninety-six percent of patients reported that the PROMs were easy to complete
• Ninety-seven percent reported that the PROMs were easy to understand
• Seventy-two percent completed the survey without a reminder call, and an additional 14% completed the survey after a reminder call

The PROMs were able to differentiate cancer center performance; one cancer center performed better than others in managing patient symptoms based on the 12 measures, and one performed worse. None of the PROMs showed acceptable reliability or validity, which could be due to the low number of patients in the study. Risk adjustment had a modest impact on cancer center performance.

Limitations

The study did not include enough patients across the six cancer centers to adequately assess reliability and validity of the PROMs.

Conclusions and Relevance

The new PROMs were acceptable to patients and could be collected from patients while they were at home. The PROMs may help evaluate quality of care, but more data are needed to establish the reliability and validity of these measures.

Future Research Needs

Future research can test the PROMs with more patients and cancer centers.