Results Summary
What was the research about?
Patients with early-stage breast cancer can often choose between two treatment options. With a mastectomy, a surgeon removes the entire breast. With breast-conserving surgery, a surgeon removes only cancerous and nearby tissue. Patients usually need radiation after this surgery.
In this study, the research team tested two conversation aids used during clinic visits to help patients choose the treatment that works best for them:
- Option Grid. A one-page, easy-to-read table of surgery options, with answers to common questions.
- Picture Option Grid. A four-page, easy-to-read summary of surgery options with pictures. This approach was designed for people of low socioeconomic status and with limited health literacy. Health literacy is knowing how to get and use information to make choices about health.
The research team compared patients who received one of these aids with patients who received usual care. Usual care included educational materials and medical guidance about breast cancer and treatments.
What were the results?
Compared with usual care, patients receiving the Picture Option Grid
- Had higher knowledge about breast cancer one week after surgery.
- Felt more involved in the decision process right after their visit, but not one week after surgery.
- Had more observed and reported shared decision making. In shared decision making, patients and doctors work together to make health choices.
- Had lower decision regret one week after surgery.
The study found no difference in reported care coordination.
Compared with usual care, patients receiving the Option Grid
- Didn’t differ in knowledge about breast cancer or decision regret
- Felt more involved in the decision process one week after surgery
- Had more observed, but not reported, shared decision making
- Reported better care coordination 12 weeks after surgery
The two aids didn’t differ from usual care on whether patients chose a treatment that aligned with their values or other quality of life outcomes.
When compared with one another, the two aids didn’t differ on any outcomes.
Who was in the study?
The study included 615 women with early-stage breast cancer. Of these, 64 percent were White, 16 percent were Black, 13 percent were Hispanic, 3 percent were Asian, and 2 percent were another race. The average age was 60, and 33 percent were of low socioeconomic status. All received care at one of seven clinics across the United States.
What did the research team do?
The research team assigned 16 surgeons to one of the three groups by chance. Surgeons used their assigned aid to talk with patients about treatment choices during their visit.
The research team surveyed patients at the start of the study, right after the visit, and again 1 week, 12 weeks, and one year after surgery. The team also observed shared decision making during the visit.
Patients, caregivers, and clinicians were part of the research team.
What were the limits of the study?
Because surgeons saw different numbers of patients, fewer patients used the Option Grid than the Picture Option Grid.
Future studies could include more patients who use the Option Grid.
How can people use the results?
Surgeons can use these results when looking for ways to support patients with early-stage breast cancer in choosing treatments.
Professional Abstract
Objective
To compare the effectiveness of two conversation aids versus usual care on improving decision quality among patients choosing between early-stage breast cancer treatment options
Study Design
| Design Elements | Description |
|---|---|
| Design | Cluster randomized controlled trial |
| Population | 615 women with stage I, II, or IIIA breast cancer who were eligible for breast-conserving surgery or mastectomy |
| Interventions/ Comparators |
|
| Outcomes |
Primary: breast cancer knowledge; patient involvement in the decision process; decision concordance Secondary: treatment choice, treatment intention, researcher-observed and patient-reported shared decision making; patient-reported anxiety, quality of life, decision regret, and care coordination |
| Timeframe | Up to 1-week follow-up after surgery for primary outcomes |
This cluster randomized controlled superiority trial compared two conversation aids summarizing breast cancer treatment options versus usual care on improving patients’ shared decision making and other outcomes.
Researchers randomly assigned 16 surgeons to use one of two paper-based conversation aids or provide usual care during the surgical consultation.
- Option Grid. A one-page summary table of treatments written in plain language, including frequently asked questions.
- Picture Option Grid. A four-page summary of treatments with pictures and plain language text designed for people of low socioeconomic status and with limited health literacy.
- Usual care. Patients received care from surgeons as usual, including educational materials and medical guidance about breast cancer and treatments.
The study included 615 women with early-stage breast cancer. Of these, 64% were White, 16% were Black, 13% were Hispanic, 3% were Asian, and 2% reported another race. The average age was 60, and 33% were of low socioeconomic status as determined by measures of income, education, and insurance status. Patients received care at one of seven clinics across the United States.
Researchers observed shared decision making during the consultation visit. Patients completed surveys at baseline, immediately after the visit, and again 1 week, 12 weeks, and one year after surgery.
Patients, caregivers, and clinicians were part of the research team.
Results
Compared with usual care, patients receiving the Picture Option Grid
- Had higher knowledge about breast cancer one week after surgery (p=0.04)
- Reported being more involved in the decision process immediately after their visit (p=0.05), but these effects were not significant one week after surgery
- Had more observed shared decision making during the clinic visit (p=0.01), more patient-reported shared decision making immediately after the visit (p=0.01), and lower decision regret one week after surgery (p=0.04)
Compared with usual care, patients receiving the Option Grid
- Did not differ significantly in knowledge about breast cancer or decision regret
- Reported being more involved in the decision process one week after surgery (p=0.01)
- Had more observed shared decision making during the visit (p=0.01) and better care coordination 12 weeks after surgery (p=0.04)
The three groups did not differ significantly on decision concordance or other secondary outcomes.
When compared with one another, the two conversation aids did not differ significantly on any outcomes.
Limitations
Because surgeons had different patient volumes, randomization at the surgeon level led to fewer patients using the Option Grid than the Picture Option Grid.
Conclusions and Relevance
Compared with usual care, conversation aids helped patients better understand their treatment options and feel more involved in the decision process.
Future Research Needs
Future studies could consider surgeons’ patient volume at randomization.
Final Research Report
View this project's final research report.
Implementation
Related PCORI Dissemination and Implementation Project
Journal Citations
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. Those comments and responses included the following:
- The reviewers asked whether the study needed to be repeated with a larger sample size to determine which paper-based conversation aid – option grid or picture option grid – patients considered more useful. The researchers acknowledged that because of difficulties they had in participant recruitment, they were not able to conduct a direct comparison between these two options. The researchers also considered it sufficient to know that both option grids were rated better than usual care, and the choice of which to use could be left to the patient and provider based on their preferences.
- One of the reviewers asked for more information regarding the surgeon’s experience with the conversation aids. The researchers explained that they did not have enough room in the current report to share that information but were working on a publication that would discuss surgeon experiences. In their response to reviewer comments, the researchers provided a summary of surgeons’ experiences with the conversation aids, noting that surgeons felt initially like the aids disrupted the flow of their medical encounters with patients, but after some use, about half of these surgeons experienced the aids as a normal part of the patient’s appointment. Surgeons in the picture option grid group were more likely than surgeons in the option grid group to feel like the conversation aids should be part of their consultations with patients. They also felt like other qualified clinic personnel could use the conversation aids.
- The reviewers asked whether the patient partners and patient associates involved in this research represented patients of low socioeconomic status, similar to the target population for the study, so that they could provide meaningful input for participant recruitment. The researchers explained that they did not collect information about socioeconomic status from their patient partners or patient associates, but two of the patient associates were from ethnic minority groups. Furthermore, the site principal investigators were responsible for identifying a patient associate for their site, so the research team could not purposively sample potential candidates for appropriate representation. Most of the patient partners and all of the patient associates were breast cancer survivors, and one patient partner represented a patient advocacy group.
Conflict of Interest Disclosures
Project Information
Key Dates
Study Registration Information
^Marie-Anne Durand, PhD, MSc, MPhil, CPsychol was this project's principal investigator when it was awarded.