Results Summary
What was the research about?
Many patients with cancer feel pain and distress as they plan for, undergo, and recover from cancer surgery. Palliative care focuses on easing pain and improving quality of life for people with a serious illness and their families.
In this study, the research team compared two ways a palliative care team could help provide care for patients having upper gastrointestinal, or GI, cancer surgery:
- Surgical team management with palliative care if needed. Patients and their caregivers received care from a surgical team before and after surgery. This care included supporting patients with their mental health and social needs, providing education about cancer, and helping them manage symptoms. Surgeons could ask for help from a palliative care team if needed.
- Surgical and palliative care team treatment. Patients and their caregivers received care from both a surgical team and a palliative care team before and after surgery. The palliative care team included nurses, social workers, pharmacists, and chaplain staff. Palliative care was given in person or by phone or internet for at least one hour per month. The palliative care team assessed patients’ symptoms. They talked to patients and their caregivers about whether their cancer was likely to improve. They also taught them about cancer treatment and ways to manage symptoms.
The research team compared how the two ways affected patients’ quality of life and other health outcomes.
What were the results?
After three months, the two ways to provide care didn’t differ in:
- Patient quality of life, how severe patients’ symptoms were after treatment, and deaths
- Patient and caregiver spiritual distress and mood
- Patient and caregiver views on the benefits of surgery
- Caregiver burden
Who was in the study?
The study included 359 patients who had upper GI cancer and 86 caregivers. Upper GI cancer includes stomach, esophagus, and small intestine cancer. Among patients, 78 percent were White, 8 percent were Black, 4 percent were Asian, 2 percent were American Indian or Alaska Native, and 8 percent were more than one race or another race. The average age was 65, and 54 percent were men. Patients received care from one of five medical centers across the United States.
What did the research team do?
The research team assigned patients and their caregivers by chance to one of the two ways to provide care.
Patients and their caregivers completed surveys at the start of the study, five days after surgery, and one and three months later. The research team tracked deaths in each group.
Patients who have had cancer surgery, caregivers, clinicians, and members of advocacy and professional organizations helped design the study.
What were the limits of the study?
Most patients in the study were White and had a high level of education. Results may have differed if the study had included more patients from other backgrounds.
Future research could look at ways to provide surgical and palliative care for patients from other backgrounds.
How can people use the results?
Clinics can use the results when considering ways to provide palliative care to patients having cancer surgery.
Professional Abstract
Objective
To compare the effectiveness of care managed by a surgical team plus palliative care consultation as needed versus care co-managed by a surgical and palliative care team in improving quality of life among patients who have had surgery for upper gastrointestinal (GI) cancer
Study Design
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 359 patients ages 18 and older and 86 caregivers; patients had undergone surgery intended to cure upper GI cancer, including cholangiocarcinoma or pancreatic, gastric, hepatocellular, or esophageal cancer |
| Interventions/ Comparators |
|
| Outcomes | Primary: patient-reported quality of life Secondary: patient-reported mood, spiritual distress, severity of physical symptoms due to cancer treatment, and views on whether surgery would help them live longer and cure cancer; patient mortality; caregiver-reported mood, spiritual distress, views on whether surgery would help the patient live longer and cure cancer, and burden |
| Timeframe | 3-month follow-up for study outcomes |
This randomized controlled trial compared the effectiveness of care managed by a surgical team plus palliative care team consultation as needed versus care co-managed by a surgical and palliative care team in improving quality of life among patients who have undergone upper GI cancer surgery.
Researchers randomly assigned patients to one of two care strategies:
- Surgical team management with palliative care if needed. Patients and their caregivers received usual care from the surgeon and surgical team before and after surgery. Care provided by the team included psychosocial support, education and communication about the patient’s disease, and management of perioperative symptoms. Surgeons followed guidelines from the National Comprehensive Cancer Network® and could consult with a palliative care team as needed.
- Surgical and palliative care team co-management. Patients and their caregivers received the same surgical team management as described in the first strategy plus palliative care from a palliative care team before and after surgery. The palliative care team included nurses, social workers, pharmacists, and chaplains. The palliative care team assessed patients’ cancer symptoms and counseled and educated patients and their caregivers about the patients’ disease and prognosis, ways to manage cancer symptoms, and treatment options. Patients and their caregivers received palliative care in person or by phone or internet for at least one hour per month.
The study included 359 patients and 86 caregivers. Patients received care at one of five medical centers across the United States after having surgery intended to cure GI cancer. Among patients, 78% were White, 8% were Black, 4% were Asian, 2% were American Indian or Alaska Native, and 8% were more than one race or another race. The average age was 65, and 54% were male.
Patients and their caregivers completed surveys about study outcomes at baseline, five days after surgery, and one and three months after surgery. Researchers tracked mortality in each group.
Patients who had undergone surgery for upper GI cancer, caregivers, clinicians, and representatives from advocacy and professional organizations helped design the study.
Results
After three months, the two strategies did not differ significantly in patient-reported quality of life or other study outcomes.
Limitations
Most of the patients in the study were White and had a high level of education. Results may differ for patients from other backgrounds.
Conclusions and Relevance
In this study, surgical team management with palliative care as needed and surgical and palliative team co-management did not differ in improving quality of life for patients after surgery for upper GI cancer.
Future Research Needs
Future research could examine the effects of care co-management by the surgical and palliative care teams on patients from other racial backgrounds and patients with lower levels of education.
COVID-19-Related Study
Patient, Caregiver, and Clinician Views on the Effects of the COVID-19 Pandemic on Care for People with Cancer
Results Summary
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
What was this COVID-19 study about?
During the COVID-19 pandemic, health systems had to change how they provide care. One change was more use of telehealth. Telehealth provides care to patients remotely using phone or video. Another change was to delay treatment for minor health problems. These changes may affect patients’ health and well-being, especially for patients with illnesses like cancer.
In this study, the research team wanted to learn how COVID-19 affected cancer care and coping during the pandemic for patients, caregivers, and clinicians, like doctors and nurses. To find out, the team used surveys and interviews as part of a cancer care study. Their goal was to come up with questions to help patients, caregivers, and clinicians talk about patient care.
What were the results?
In surveys and interviews, patients and caregivers said they were coping well with cancer care during the pandemic. Most said that the pandemic didn’t change patients’ cancer care. But in interviews, clinicians said that the pandemic led to widespread changes in cancer care. They also reported feeling anxiety, fatigue, and distress about these changes.
In 61 percent of surveys, patients and caregivers said they had a telehealth visit for cancer care and liked it. Among patients, 32 percent preferred telehealth, 26 percent preferred in-person care, and 42 percent were neutral. Clinicians said that telehealth visits were useful for healthy patients. But they preferred in-person visits for patients who were ill or frail.
Based on these results, the research team created six questions to use during cancer care visits. These questions can help patients, caregivers, and clinicians talk about coping, changes to cancer care due to the pandemic, and telehealth preferences.
What did the research team do?
The research team sent surveys to patients and caregivers five times during the study. The team collected 424 surveys from 181 patients and 67 surveys from 26 caregivers. All patients had surgery to treat cancer of the pancreas, stomach, esophagus, liver, or gallbladder. Of these, 82 percent were White, 6 percent were Asian, and 3 percent were Black. Also, 1 percent were American Indian or Alaska Native, 2 percent were more than one race, and 7 percent were another race; 11 percent were Hispanic. In addition, 55 percent were men. All received care at one of four hospitals in four states.
The research team also interviewed 48 patients, six caregivers, and 19 clinicians.
Patients with cancer, caregivers, clinicians, and professional and advocacy group members provided input during the study.
What were the limits of the study?
Most patients and caregivers were White. Results may differ for people of other racial backgrounds. Because hospitals limited visits due to COVID-19, fewer caregivers than planned joined the study. Results may have differed if more caregivers were in the study.
How can people use the results?
Health systems can use the results to help patients with cancer, caregivers, and clinicians communicate about cancer care during the pandemic.
Professional Abstract
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
Background
People with cancer face special challenges related to the COVID-19 pandemic. Delays in receiving potentially life-prolonging cancer treatments, fear of COVID-19, and social distancing policies related to the COVID-19 pandemic may negatively affect patients’ health and well-being.
Objective
To explore the impact of the COVID-19 pandemic on coping, telehealth use, and cancer treatment among patients with cancer, their caregivers, and clinicians to develop questions to help facilitate communication between patients and clinicians
Study Design
| Design Element | Description |
|---|---|
| Design | Mixed methods (surveys and interviews) |
| Population | Survey: 181 patients who had surgery to treat upper gastrointestinal cancer and who were enrolled in an ongoing randomized controlled trial examining palliative care and 26 family caregivers, across four study sites Interviews: 48 patients who had surgery to treat cancer, 4 family caregivers, and 19 cancer clinicians |
| Outcomes | Coping with COVID-19 pandemic, coping with cancer, telehealth use, pandemic-related treatment delays, and changes in cancer treatments Development of a question set asking about changes to cancer care during the pandemic, concerns about cancer care during the pandemic, and preferences for telehealth and in-person visits |
| Data Collection Timeframe | Survey: October 2020–August 2021 Interviews: August 2020–July 2021 |
This study explored how cancer treatment and coping among patients, family caregivers, and clinicians was affected by the COVID-19 pandemic. Patients and caregivers were enrolled in an ongoing clinical trial on palliative care.
Patients and caregivers completed surveys about cancer treatment and coping at enrollment and then one week, one month, three months, and six months post-surgery. Patients who had surgery more than six months prior and their caregivers were reenrolled in the study and completed surveys every three months. Researchers collected 424 surveys from 181 patients and 67 surveys from 26 caregivers. Among patients, 82% were White, 6% were Asian, 3% were Black, 1% were American Indian or Alaska Native, 2% were multiracial, and 7% were another race; 11% were Hispanic. Also, 55% were male. Patients received care at one of four hospitals located in four states.
Researchers also conducted interviews about coping and cancer treatment with 48 patients, six caregivers, and 19 clinicians.
Patients with cancer, family caregivers, clinicians, and representatives from professional and advocacy groups provided input throughout the study.
Results
Across surveys and interviews, patients and caregivers reported coping well with cancer treatments during the pandemic. They also reported that the pandemic did not substantially change their cancer care. In contrast, clinician interviewees described widespread pandemic-related changes to cancer care. They also reported anxiety, fatigue, and moral distress about these changes.
In 61% of surveys, patients and caregivers reported having a telehealth visit for cancer care, with 69% of respondents reporting that they liked telehealth visits for cancer care. Among patients, 32% preferred telehealth, 26% preferred in-person visits, and 42% were neutral. Clinicians reported that telehealth visits were useful for healthy patients, but they preferred in-person visits for patients who were ill or frail.
Based on these results, the research team developed six questions to improve communication between patients, caregivers, and clinicians. The questions ask about pandemic-related care changes and concerns, coping, and preferences for telehealth.
Limitations
Demographics varied by site; most patients and caregivers were White. Findings may not be generalizable to other locations or populations. Caregiver recruitment was lower than expected due to COVID-19 visitor restrictions, which may have affected study results.
Conclusions and Relevance
In this study, patients and caregivers felt supported during pandemic-related changes to their cancer care, whereas clinicians expressed feelings of anxiety, fatigue, and distress. Health systems can use the results to facilitate communication between patients with cancer, caregivers, and clinicians during the COVID-19 pandemic.
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 the researchers to provide a conceptual framework for their qualitative interviews. The researchers explained that while they agree about the importance of using conceptual models, their early work in this area did not identify an appropriate model to use. Therefore, they felt it would be more appropriate to go into the interviews with a more open and exploratory mindset focused on key themes that would help them work towards establishing an appropriate conceptual framework in the future.
- The reviewers questioned whether the study represented shared decision making as referenced in the report because the reviewers did not see the development of an assessment tool to allow patients to voice their feelings regarding telehealth delivery and in-person care during the COVID pandemic as a shared decision making intervention. The researchers agreed, explaining that they initially believed that patients and caregivers would want to participate in shared decision making with their clinicians regarding their cancer treatments. As data were collected the researchers discovered that in fact patients and their caregivers were more comfortable with their medical teams making decisions about their treatments, so the researchers decided to focus on creating a communication tool rather than a shared decision making tool. The researchers revised the report to describe these events more clearly and explain why they changed their original study goals.
- The reviewers requested a clearer explanation of how the researchers used their survey and qualitative interview results to develop their communication tool. The reviewers also asked about the results from survey and interview questions that were not described in the report. The researchers added these additional results to the report and added flow charts to the report to demonstrate how the survey and interview data contributed to the development of the communication tool.
- The reviewers expressed concern about the communication tool adding time to physician visits and asked whether the tool was currently in use anywhere. The researchers said that the tool has not been implemented because they are still collecting stakeholder data. The researchers noted that their study stakeholders were also concerned about the tool adding time to the doctor’s visit, so the researchers added this question to the report’s discussion of future research directions.
- One reviewer asked about modifying this communication tool so it could be used more broadly outside of the COVID-19 environment. The researchers explained that they were focused specifically on developing a tool to use during the pandemic but agreed that the tool could be relevant for understanding general patient preferences regarding their care. They added this idea to their future research directions as well.
Final Enhancement Report
View this COVID-19 study's final enhancement report.
DOI - Digital Object Identifier: 10.25302/03.2023.IHS.160936518-C19
Final Research Report
This project's final research report is expected to be available by August 2024.
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 recommended that the researchers state more explicitly that the study did not identify any significant differences in quality of life between the two study interventions. The authors revised the report conclusion, clarifying that the results of the study did not support an assumption that early integration of palliative care amongst surgical oncology patients pursuing curative-intent surgeries improves patient-reported quality of life or mood symptoms.
- The reviewers asked the researchers to clarify if there was only one session of perioperative palliative care for each patient. The authors added information indicating that patients engaged in multiple palliative care meetings during the study.
- The reviewers asked to describe the researchers’ approach to missing data. The authors explained that the first priority outcome value was that observed at three months, and if it was missing, they imputed it with six months, then two months or one month to obtain a value for follow up. They further explained that if none of these outcomes were observed the patient was excluded from the analysis.
Project Information
Key Dates
Study Registration Information
^This project was originally led by Rebecca A. Aslakson MD, PhD, at Johns Hopkins University in Maryland.