Results Summary
What was the research about?
Men with localized prostate cancer, or cancer that hasn’t spread beyond the prostate gland, have many treatment options, including
- Surgery to remove the prostate gland
- Radiation therapy, which uses beams of radiation to destroy cancerous tissue in the prostate gland
- Active watching and waiting, or active surveillance, which means getting checked every few months by a doctor to make sure the cancer isn’t spreading
Each option has benefits as well as risks or side effects.
In this study, the research team developed and tested a web-based intervention called PreProCare. PreProCare helps patients think about their preferences for treatment and share them with their doctors. The team looked at whether patients who used PreProCare were more satisfied with their care and treatment decision than patients who didn’t use PreProCare.
What were the results?
Compared with the patients who didn’t use PreProCare, those who did
- Were more satisfied with their care and their treatment choice
- Felt less regret about their choice
- Were more likely to be on active surveillance if they were at low risk for the cancer to spread
- Were less likely to have some severe urinary problems like pain with urination or poor bladder control
- Were more likely to have bladder control that was as good as before they had the treatment
- Could get back to daily physical tasks sooner
- Were less likely to have high levels of depression
- Had better social functioning, such as feeling comfortable being around others
The two groups didn’t differ in 8 ways of measuring quality of life and 13 other ways of measuring prostate-related quality of life.
Who was in the study?
The study included 743 men with localized prostate cancer getting care at one of three hospitals in Philadelphia, Pennsylvania. Of these, 82 percent were white, 14 percent were African American, and 3 percent were from other races. The average age was 64. In addition, 61 percent had a college degree or higher, and 63 percent had an annual income of at least $75,000.
What did the research team do?
The research team assigned patients to one of two groups by chance. Patients in one group used PreProCare before talking about treatment with their doctors. Patients used PreProCare either at home or at the hospital to rank their preferences. Preferences were about aspects of treatment, such as how long it would take to feel better and how likely they would be to stay cancer-free after treatment. Patients could then get graphs and printed lists of their preferences to share with their doctors. The other group of patients received standard educational materials about prostate cancer.
Patients took surveys about their quality of life and treatment choices before their doctor visits and again 3, 6, 12, and 24 months later.
Prostate cancer survivors, nurses, and doctors helped the research team create PreProCare.
What were the limits of the study?
All patients received care in one city. Most patients in the study were white and highly educated and had high incomes. Results may differ for people in other cities or from different backgrounds. Also, doctors in the study didn’t have training on how to discuss the results from PreProCare with patients.
Future research could look at how PreProCare works for people from other groups or living in other places.
How can people use the results?
Doctors can use these results when considering ways to help patients think about and share preferences about treatment for localized prostate cancer.
Professional Abstract
Objective
To compare the effectiveness of PreProCare, a web-based preference assessment intervention, with standard education materials on improving men’s satisfaction with care for localized prostate cancer
Study Design
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 743 men with localized prostate cancer |
| Interventions/ Comparators |
|
| Outcomes |
Primary: satisfaction with care Secondary: satisfaction with decision, regret about treatment decisions, quality of life, prostate-specific quality of life, depression symptoms, urologic symptoms, treatment choice |
| Timeframe | 2-year follow-up for primary outcome |
This randomized controlled trial compared the effectiveness of PreProCare, a self-administered web-based intervention, with usual care including standard educational materials on improving satisfaction with care and treatment decision for men with localized prostate cancer. PreProCare is designed to help men assess their preferences among three treatment options.
The research team randomly assigned patients to use PreProCare or receive usual care. Patients used PreProCare during their office visit with a provided laptop computer or at home with their own computer before meeting with their doctors to discuss treatment options. The PreProCare intervention asked patients to rank the importance of treatment characteristics such as survival, cancer control, change in urinary function, and recovery time, from not important to extremely important. After ranking, patients made hypothetical choices between treatment options based on varying combinations of treatment characteristics. When they completed PreProCare, patients could share a graph and a printed list of their preferences with their doctor. It took about 30 minutes to complete PreProCare. Men receiving usual care received standard educational materials about prostate cancer.
The study included 743 men with localized prostate cancer, recruited from three medical centers in Philadelphia, Pennsylvania. Of these, 82% were white, 14% were African American, and 3% reported another race. The average age was 64. In addition, 61% had a college degree or higher, and 63% had an annual income above $75,000.
Patients completed surveys to assess study outcomes at baseline and again 3, 6, 12, and 24 months later.
Prostate cancer survivors and clinicians helped develop PreProCare.
Results
At two-year follow-up, compared with the group receiving usual care, the group that used PreProCare had significantly (p<0.05)
- Greater satisfaction with care
- Greater satisfaction with their treatment decision
- Less regret about their treatment decision
- Fewer severe urologic symptoms
- Lower likelihood of having a high depression score
- For low-risk patients, greater likelihood of being on active surveillance
For quality of life and prostate-specific quality of life measures, compared with the group receiving usual care, the group that used PreProCare had a significantly (p<0.05)
- Smaller decline in physical and social functioning scores
- Higher proportion of men return to their baseline scores for urinary incontinence
The groups did not differ significantly in the 8 other quality of life measures or the 13 other prostate-specific quality of life measures.
Limitations
Most patients in the study were white and highly educated, had relatively high incomes, and were receiving treatment in one city. Findings may differ in other populations or settings. Also, doctors in the study did not receive training in discussing the results of PreProCare with patients.
Conclusions and Relevance
Compared with usual care, the PreProCare preference assessment intervention may help patients with localized prostate cancer work with their clinicians to make treatment decisions.
Future Research Needs
Future research could test PreProCare in different settings or populations.
Final Research Report
View this project's final research report.
Journal Citations
Article Highlight: Men with prostate cancer face an array of treatment options. So this study's principal investigator and his team designed a tool that outlines the advantages and disadvantages of these options so patients can consider which best align with their preferences. As the research team reports in a new article in the Journal of Clinical Oncology, compared to patients who received usual care, those who used the decision tool reported improved satisfaction with their care.
Results of This Project
Related Journal Citations
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented, and the researchers made changes or provided responses. The comments and responses included the following:
- Reviewers asked for a clearer delineation of the roles of patients and stakeholders in influencing the design and conduct of the study. The researchers responded, describing the separate roles of patients and other stakeholders in the first phase of the study.
- Reviewers expressed concern about the number of study outcomes that researchers measured and analyzed at multiple time points, introducing the possibility for false positives or Type 1 error. Reviewers suggested that the researchers address this issue of multiple comparisons in part by using longitudinal analyses that would report an overall effect incorporating all time points. The researchers explained that there was one primary outcome, satisfaction with care, and that they used the Bonferroni correction for multiple comparisons to reduce the risk of Type 1 error.
- Reviewers also noted that one of the factors contributing to having multiple comparisons was that the researchers reported some outcome measures item-by-item rather than as a total or summary score. The reviewers suggested removing these single-item outcomes unless there was a strong rationale for item-by-item analysis. The researchers stated that the individual items represented different domains. Therefore, their individual results were of interest.
- Reviewers suggested adding information to the discussion section about how the PreProCare tool could be successfully implemented into clinical practices. The researchers responded, providing additional details on implementation of the study results. In the discussion section, the researchers described specific areas of clinical practices that would benefit from additional attention, such as physician and staff training, provision of the tool to patients before their scheduled visits and sharing results from the tool with patients and their clinicians.