Results Summary
What was the research about?
Chemotherapy is using medicine to treat cancer. Patients with ovarian cancer may have to choose between two ways to get chemotherapy:
- Intravenous, or IV, therapy, delivers medicine into a vein.
- Intraperitoneal, or IP, therapy, delivers medicine under the muscles in the belly using a thin tube. It’s used together with IV therapy.
Choosing between the two ways can be hard. IP therapy may be better at treating cancer; IV therapy may have fewer side effects.
In this study, the research team created a decision aid. Decision aids help people choose between two or more treatment options based on what is most important to them. The decision aid discussed side effects and chances of survival for each way of receiving chemotherapy. The team wanted to learn if the decision aid helped patients feel more satisfied with their decision than patients who didn’t use the decision aid.
What were the results?
Patients who used the decision aid and those who didn’t reported similar levels of
- Satisfaction with their decision about the way to get chemotherapy
- Shared decision making, which is a process in which patients and doctors work together to choose a treatment
- Satisfaction with treatment and care
- Quality of life
- Side effects
Patients who reported a lower quality of life and lower levels of shared decision making at the first visit they had with their doctor after surgery had less satisfaction and more regret about their decision over time.
Who was in the study?
The study included 123 women with ovarian cancer who had surgery to remove tumors. Patients received care from one of nine cancer clinics across the United States. Of these patients, 92 percent were white, and 8 percent were other races. The average age was 58.
What did the research team do?
The research team assigned patients to one of two groups by chance. In the first group, patients received the decision aid before their first doctor visit to talk about chemotherapy. In the second group, patients didn’t receive the decision aid.
Before the first doctor visit, patients took a survey about their quality of life and side effects, such as nerve pain and stomach problems. After choosing a way to get chemotherapy, patients took a survey that asked how satisfied they were with their choice and the level of shared decision making involved in making the choice. Patients also took surveys about how satisfied they were with their choice and their treatment and care halfway through treatment, one month after treatment ended, and nine months after the start of the study.
A group of patients who had had ovarian cancer helped design the decision aid and recruit patients.
What were the limits of the study?
When choosing a way to get chemotherapy, some patients found it hard to weigh concerns about side effects with chances of survival.
Future research could determine how best to present information on weighing important concerns to help patients choose a treatment.
How can people use the results?
Doctors can consider these results when thinking about how best to engage in shared decision making with patients.
Professional Abstract
Objective
To compare the effectiveness of providing patients with a decision aid about chemotherapy delivery options versus no decision aid on improving patient decision satisfaction and reducing decision regret
Study Design
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 123 stage II, III, and IV patients with ovarian cancer who were candidates for IV or IP/IV chemotherapy treatment following surgery to remove tumors |
| Interventions/ Comparators |
|
| Outcomes | Primary: patient satisfaction with treatment delivery decision, patient regret with treatment delivery decision Secondary: patient QOL, patient side effects (neuropathy, abdominal discomfort, fatigue), level of shared decision making, patient satisfaction with care and treatment |
| Timeframe | 9-month follow-up for primary outcomes |
This randomized controlled trial tested the effectiveness of a decision aid on helping patients with ovarian cancer decide between intravenous (IV) chemotherapy alone or IV chemotherapy in combination with intraperitoneal (IP/IV) chemotherapy. Prior research indicates that IP/IV therapy may be more effective at treating cancer, while IV therapy may have fewer side effects.
Researchers randomly assigned patients to one of two groups. In the first group, patients used the decision aid prior to the first visit with their oncologist after surgery. The decision aid provided information about side effects and survival for IV chemotherapy, and IV/IP chemotherapy delivery. In the second group, patients received usual care; they discussed delivery options with their oncologist without the decision aid.
The study included 123 women who had ovarian tumors removed through surgery and who were candidates for IV or IP/IV chemotherapy. Patients received care at one of nine gynecologic cancer practices across the United States. Of these patients, 92 percent were white, and 8 percent were other races. The average age was 58.
Patients completed a baseline survey on their quality of life (QOL) and levels of neuropathy, abdominal discomfort, and fatigue. After deciding on a chemotherapy delivery option, patients took another survey measuring decision satisfaction, regret, and the level of shared decision making. Patients then took surveys about study outcomes halfway through treatment, one month after treatment ended, and nine months after the study started.
A group of patients who had had ovarian cancer helped design the decision aid and recruit patients.
Results
Decision satisfaction and regret did not differ significantly at any time point in the study between patients who received the decision aid and patients who did not. Patients in both groups reported a high level of satisfaction with their decision and a low level of decisional regret at all time points.
Levels of shared decision making, patient satisfaction with their treatment and care, QOL, and side effects did not differ significantly between groups.
In both groups, lower levels of shared decision making and QOL at the first study visit were associated with lower patient decision satisfaction and higher regret later in the study.
Limitations
Some patients found it difficult to use the decision aid, particularly in weighing survival time against side effects.
Conclusions and Relevance
In this study, patients who used the decision aid did not differ in decision satisfaction or regret compared with patients who did not use the decision aid. The level of shared decision making and QOL at the initial visit were strong predictors of these primary outcomes.
Future Research Needs
Future research could explore how best to present information about weighing side effects and survival time to help patients choose between the two modes of chemotherapy delivery.
Final Research Report
View this project's final research report.
Journal Citations
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 noted that the report cited a few studies that supported the need for further research but no systematic reviews. They asked what methods the researchers used to review the literature. The researchers replied that they conducted a thorough review of the literature spanning 20 years when developing their grant application. They said their search focused on medical decision making and especially female-cancer decision making.
- Reviewers recommended that the researchers should give more attention to patients who received additional therapy before surgery, as this could significantly affect the study outcomes. The researchers explained that they did examine these factors as possible confounders in the analyses but did not observe a significant effect on the outcomes. They did add more discussion of the patient subgroup receiving previous therapy to the report.
- The reviewers said that outcomes should represent concerns of the population of interest and suggested that quality of life was not sufficiently emphasized in the report. The researchers added text and a new figure (Figure 3) to describe trends in quality of life. They said their primary interest was in how quality of life might influence participants’ satisfaction with their treatment decisions.
- The reviewers asked for an analysis of inconsistencies between original plans and how the researchers carried out the study, and specifically the switch from a final follow-up time from one year to nine months. They asked how the researchers managed the missing data. The researchers responded that they conducted statistical analyses as planned. They said the reason for changing the final follow-up time point from one year to nine months was because of unexpected time constraints with the PCORI contract. They also changed it because the study team wanted to stay close to the planned 80 percent retention rate for the study. Due to the seriousness of the disease, retention was only 62 percent at 12 months but 81 percent at 9 months.
- The reviewers asked how the decision aid could be improved and, if shown to be effective, how it could be disseminated and implemented among patients. The researchers said the educational module of their decision aid was very well received and considered useful in describing treatment options and side effects. They noted that technical misunderstandings (e.g., needing to swipe on an iPad) may have impeded the gathering of some data, but that many participants liked the gaming feature. The researchers also acknowledged that some aspects of the educational module may have overwhelmed patients with more information than they wanted, but many clinicians said they would like to see the decision aid adapted for use with patients who have recurrent ovarian cancer. The researchers said they foresee the aid being useful in the context of other advanced cancer types and other treatment choices.