Results Summary
What was the research about?
Surgery can treat many types of cancer. Patients who have cancer surgery often stay in the hospital for one day or less. These patients and their caregivers manage recovery by themselves at home, which can be stressful. Support for managing patient symptoms at home may reduce symptoms and anxiety. It may also prevent unplanned visits to the hospital or emergency room, or ER.
In this study, the research team compared two approaches to help patients manage symptoms at home after cancer surgery. In both, patients entered details about their symptoms and anxiety in an online survey each day for 10 days. Then, for those 10 days, patients received information in one of two ways:
- Team monitoring. Healthcare providers, such as doctors or nurses, called patients if their symptoms were above a certain level.
- Enhanced feedback. Patients received a report right after completing the survey. It showed how their symptoms compared with those of other patients who had similar cancer surgery.
All patients received an alert to seek health care if reported symptoms were too severe.
What were the results?
Patients who received enhanced feedback made fewer calls to nurses in the month after surgery than patients who received team monitoring. Also, anxiety decreased faster for patients who received enhanced feedback.
The two approaches didn’t differ in:
- The number of patients who went to the ER or returned to the hospital in the month after surgery
- The number of patients who received referrals to manage pain in the month after surgery
- Adverse events from surgery, such as infection
- Patients’ confidence in managing their health two months after surgery
- Caregiver burden two months after surgery
Who was in the study?
The study included 2,624 patients receiving cancer surgery at an outpatient surgery center in New York City and their caregivers. Patients had surgery for breast, reproductive, urinary, or head and neck cancer. Of these patients, 81 percent were White, 6 percent were African American, 6 percent were Asian, and 3 percent were another race; 7 percent were Hispanic. The average age was 54, and 72 percent were women.
What did the research team do?
The research team assigned patients by chance to receive team monitoring or enhanced feedback. The team reviewed health records to track healthcare use for one month after surgery. The daily online survey had questions about anxiety. Two months after surgery, patients completed surveys about their confidence in managing their health. Caregivers also filled out a survey about burden.
Patients, caregivers, providers, researchers, and hospital staff helped design and conduct the study.
What were the limits of the study?
Patients at outpatient surgery centers are generally healthier and have less complex follow-up care needs than patients who have cancer surgery in hospital settings. The results may not apply to patients having surgery in hospitals.
Future studies could include patients having surgery in hospital settings.
How can people use the results?
Surgery centers can use the results when considering how to help patients manage their symptoms after cancer surgery.
Professional Abstract
Objective
To compare the effectiveness of two approaches for managing patient-reported symptoms after ambulatory cancer surgery in reducing unplanned emergency department (ED) visits and increasing patient well-being
Study Design
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 2,624 patients ages 18 and older undergoing ambulatory surgery for breast, gynecologic, urologic, or head and neck cancer and 1,099 caregivers |
| Interventions/ Comparators |
|
| Outcomes |
Primary: unplanned ED visits that do not result in hospital admission, frequency of readmission, surgical adverse events, symptom-triggered interventions (calls to nurses after surgery and referrals to pain management specialists) Secondary: patient engagement (measured by the Patient Activation Measure) and anxiety; caregiver burden |
| Timeframe | 1-month follow-up for primary outcomes |
This randomized controlled trial compared the effectiveness of two methods—team monitoring versus enhanced feedback—for managing patient-reported symptoms after ambulatory cancer surgery in reducing unplanned ED visits, patient anxiety, caregiver burden, and surgical adverse events and increasing patient engagement.
Researchers randomized patients to one of the two approaches. In both approaches, patients completed an online survey about their level of symptoms each day for 10 days after surgery. After completing each survey, patients received information to help manage their symptoms in one of two ways:
- Team monitoring. Healthcare providers contacted patients by phone if the patients reported any symptoms above a certain threshold on their survey.
- Enhanced feedback. Patients received a report immediately after finishing their survey that showed their own symptom data compared with data from patients who had similar surgeries.
All patients received notification to seek medical attention immediately after survey completion if their symptoms were too severe.
Researchers reviewed electronic medical records to track the number of ED visits, hospital readmissions, adverse surgical events, and patient calls with nurses for 30 days after surgery. At 14 and 60 days following surgery, patients completed a survey about engagement and caregivers completed a survey about burden. Patients’ daily surveys included questions about anxiety.
The study included 2,624 patients undergoing ambulatory cancer surgery in New York City and their caregivers. Of these patients, 81% were White, 6% were African American, 6% were Asian, and 3% were another race; 7% were Hispanic. The average age was 54, and 72% were female.
Patients, caregivers, clinicians, researchers, and hospital staff helped inform the design and conduct of the study.
Results
The two approaches did not differ significantly in the proportion of patients who sought care at the ED one month after surgery or in readmission frequency, surgical adverse events, pain management referrals within one month, or patient engagement or caregiver burden within two months of surgery. However, patients who received enhanced feedback made 10% fewer nursing calls 30 days after surgery than patients who received team monitoring (p<0.001).
Patients who received enhanced feedback also had a quicker reduction in anxiety than patients who received team monitoring (p<0.001).
Limitations
Patients who have surgery at ambulatory cancer centers are generally healthier and have less complex post-surgical follow-up needs than patients who have cancer surgery in hospital settings. The results may not apply to patients in other settings.
Conclusions and Relevance
In this study, the two approaches did not differ in reducing ED use after cancer surgery, but the enhanced feedback approach reduced patient calls to nurses and reduced patient anxiety faster than team monitoring.
Future Research Needs
Future research could test the enhanced feedback intervention with patients who have more complex surgical needs.
Final Research Report
View this project's final research report.
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 questioned how the researchers identified the number of study participants who were included in the planned analyses because it was not clear whether participants were excluded from analyses based on unforeseen factors such as rescinding their consent to participate in the study, participants not going through with the planned surgery, and changes to the study protocol which made some of the participants ineligible for the study. Over several revisions, the researchers clarified which participants were excluded from the analyses for the reasons stated above, and also clarified that participants who received incorrect feedback or missed other elements of the intervention were not excluded from analyses.
- The reviewers questioned the researchers’ assertions that their comparison analyses could not have been biased by the removal of participants from the analyses for the reasons stated above. The reviewers also noted that if participants were randomized to feedback group after the surgery these analysis problems could have been avoided. The researchers explained that the clinicians who determined whether to cancel a surgery or change the surgical procedures did not know to which feedback group participants were randomized, so their decisions could not have been biased based on group assignment. Further, the researchers explained that study participants had to be randomized before their surgeries because they needed to complete all study recruitment activities in order to complete baseline study questionnaires. The researchers did clarify the number of patients included in the analyses and added language to their limitations section regarding the potential for bias in the results, however small, due to removing some participants from the analyses.
- The reviewers asked for more detail about the patient and stakeholder engagement activities in this research project. They noted that the report did not describe how patients and other stakeholders contributed to study priorities, the research question or study design and therefore could not be considered “partners” to the investigators. The researchers assured the reviewers that community members were treated as study partners and this was reflected in the feedback these community members gave the investigators. The researchers expanded their description of patient partners’ participation in study planning and decision making.