Results Summary
What was the research about?
Prostate cancer is one of the most common types of cancer in men. More than 3 million men in the United States have prostate cancer. There are many treatment options. But choosing the best treatment can be hard. In this study, the research team wanted to help men with prostate cancer and their caregivers make decisions about treatment. Caregivers in this study included the men’s partners or spouses.
The team compared two groups of men and their caregivers. The first group received a mobile app called the Personalized Health Information Navigator. The app had information about the benefits and risks of all prostate cancer treatment options. It also helped men with prostate cancer make decisions based on what’s important to them. The second group received paper booklets with similar information about treatment options. Men and their caregivers in both groups worked with a community support person during the study. The support person went over the information in the app or paper booklet.
What were the results?
The research team didn’t find any differences between the effect of the app or the paper booklet on what people learned and how men and their caregivers felt about making treatment decisions. But in both groups, almost all the men and caregivers reported increased satisfaction with their treatment decisions. At the end of the study, caregivers from both groups knew more about prostate cancer than they did at the start.
Who was in the study?
The study included 179 patient and caregiver pairs. The pairs included men with prostate cancer who had not yet started treatment and their caregivers. Of the men in the study, 87 percent were white, and the average age was 63. Of the caregivers, 97 percent were women, 84 percent were white, and the average age was 59.
What did the research team do?
The research team assigned the patient and caregiver pairs by chance to receive either the app or the paper booklets. Men and caregivers in both groups went over the information with a community support person. The support person met with them every week for six weeks in person or by phone.
Men and their caregivers filled out surveys at the start of the study, right after the last meeting with the community support person, and at 6 and 12 months after the study started. The surveys asked men and caregivers
- If they were satisfied with the treatment choice they made
- What they knew about prostate cancer
- If they felt ready to make a treatment decision
A community health advocate and a prostate cancer survivor worked with the research team during the study.
What were the limits of the study?
Only 15 percent of all the men and caregivers involved in the study completed the final survey. The results might be different if more people filled out all the surveys. The research team invited people from many races to join the study, but most men who took part in the study were white. The results might be different for men of other races.
Future research could repeat this study and try to get more men and caregivers to complete the final survey. Studies could also include men and caregivers of different races.
How can people use the results?
Having a community support person share information about the benefits and risks of prostate cancer treatment options—using either the app or the paper booklet—can help men and their caregivers make treatment decisions.
Professional Abstract
Objective
To test the effect of a tablet-based decision aid for patients with a recent diagnosis of prostate cancer and their caregivers compared with standard treatment information provided in booklets
Study Design
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 179 patient/caregiver pairs where the patient had a recent diagnosis of prostate cancer |
| Interventions/ Comparators |
|
| Outcomes |
Prostate cancer knowledge, satisfaction with preparation for decision making, decisional satisfaction |
| Timeframe | 12-month follow-up for study outcomes |
Researchers conducted a randomized controlled trial to compare the Personalized Health Information Navigator (PHIN™), a newly developed decision-support application (app), with printed information about treatment options for prostate cancer from the National Cancer Institute. Delivered on an iPad®, the app provided patients and their caregivers with evidence-based, tailored information to help choose among treatment options for prostate cancer that are consistent with their personal preferences.
Both study arms used community navigators. Community navigators assisted in recruiting patients and caregivers, collected baseline data, and delivered either the tablet with the PHIN app or the printed information booklet. The navigators met with the men and their caregivers once a week for six weeks in person or by phone. In both arms, navigators helped the pairs go through the materials and answered questions about the information provided.
Patients in the study were men diagnosed with prostate cancer in the prior six months who had not yet started treatment. Of the men in the study, 87% were white, and the average age was 63. Caregivers included patients’ partners and spouses. Of the caregivers in the study, 97% were women, 84% were white, and the average age was 59.
Researchers randomly assigned 179 patient and caregiver pairs to receive either the mobile tablet with the app or standard information booklets. Patients and caregivers completed surveys at baseline, 6 weeks postintervention, and 6 and 12 months after baseline. Surveys asked about patient and caregiver knowledge of treatment options, satisfaction with preparation for decision making, and satisfaction with decisions.
A community health advocate and a prostate cancer survivor helped researchers develop the PHIN, review the paper booklet, and give input on recruitment strategies.
Results
Patients and caregivers who received the tablet app and those who received the printed materials did not differ in any study outcomes. In both groups, caregivers’ knowledge of prostate cancer increased from the start to the end of the study (p<0.01), and satisfaction with decisions improved over time for patients (p<0.05) and caregivers (p<0.01). Neither group experienced significant improvements in preparation for decision making.
Limitations
Attrition may have biased the results, as researchers were only able to contact 15% of randomized patients and caregivers at 12 months. Although the research team invited people from different races to join the study, most of the men who enrolled were white; results may be different for men of other races.
Conclusions and Relevance
Regardless of whether they used a computer-based app or a paper booklet, both patients and caregivers benefited from receiving information on prostate cancer treatment with the help of a community navigator. There were no differences in outcomes between the two randomized groups. However, the low follow-up response rate at 12 months makes this conclusion uncertain.
Future Research Needs
Future research could examine the effect of PHIN in a more diverse group of patients and caregivers. In addition, studies could aim to increase follow-up response rates for men and their caregivers.
Final Research Report
View this project's final research report.
Stories and Videos
PCORI Stories
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.
Reviewers’ comments and the investigator’s change in response included the following:
- The awardee revised the abstract and conclusion to state prominently that patient outcomes were the same in the two treatment conditions.
- The investigator expanded its introduction by presenting background literature on the development and testing of patient decision aids to help put the study into context.
- Reviewers asked why the investigator did not record the decision choices of study participants. The awardee explained that it captured this information, but reporting this information was not part of the original study aims. Therefore, any analyses based on patient choices would have added complexity to the project. The investigator stated that this would, however, be a potential area for future research.
- The awardee added to its list of limitations that the study had difficulty recruiting patients from all relevant racial and ethnic groups and then experienced high attrition. These factors limited the validity and generalizability of study results.
- The awardee commented in its limitations section that the study coordinators and community navigators recruited patients and conducted the follow-up surveys. These dual roles may have introduced bias in patients’ and caregivers’ responses on the surveys. In future research, the awardee suggested that the study personnel responsible for recruitment should not also be responsible for data collection to reduce this risk of bias.
- The awardee stated that it had difficulty engaging patients and caregivers to participate in the advisory panel, leading to limited feedback from advisors.
Conflict of Interest Disclosures
Project Information
Key Dates
Study Registration Information
^Brian Rivers, BS, MPH, PhD, was the original principal investigator on this project.