What was the research about?
Patients with cancer often have pain, feel tired, or have other symptoms. These symptoms can be severe or get in the way of daily activities, and negatively affect patients’ lives.
The research team wanted to learn if a program for managing symptoms at home, called COPE, helped people with cancer have better quality of life, feel less depressed and anxious, and improve symptoms. In COPE, patients learned specific problem-solving skills. They met with a trained staff person three times and had two follow-up phone calls. Patients also watched a video and received written information. The team asked patients to keep a symptom diary.
The research team compared a group of patients who had usual care plus the COPE program with a group who had usual care alone and a group who had usual care plus extra support. With usual care, nurses taught patients how to manage their symptoms and whom to call for help. Patients in the group that got extra support had the same number of meetings and calls with trained staff as patients in COPE, but they didn’t learn the skills in the COPE program.
What were the results?
Patients in COPE didn’t have better quality of life or feel less depressed or anxious than patients in the other two groups. The intensity of symptoms decreased more for patients in COPE than patients who had usual care alone, but it was about the same for patients in COPE and patients who had extra support without learning the COPE program. How much patients’ symptoms bothered them and patients’ confidence in managing symptoms didn’t differ among the three groups.
Who was in the study?
The study included 534 patients at a cancer treatment center in Florida. Of these, 89 percent were white. The average age was 58, and 57 percent were women. Patients were starting cancer treatment and had symptoms that upset them or that got in the way of their daily activities.
What did the research team do?
The research team assigned patients to one of the three groups by chance. The team collected study information in person and by phone when the study began, and then every week for 10 weeks. The team asked patients about their quality of life, feelings of depression and anxiety, and symptoms.
A group of patients reviewed the COPE program guide and video and gave input during the study.
What were the limits of the study?
This study didn’t look at how well patients understood or remembered the COPE program. The program may not have worked as expected if people didn’t find the information useful or memorable. Most patients in this study were white and were receiving care at one cancer center. Results might differ in other locations or with other patients.
Future studies could examine other programs to help people with cancer manage symptoms at home. Researchers could also look at ways to make the COPE program more helpful for patients.
How can people use the results?
Cancer treatment centers can use these results when looking at ways to help patients manage symptoms at home.
To evaluate whether an intervention that teaches patients to manage symptoms at home improves quality of life (QOL), anxiety, and depression for patients with cancer versus (1) usual care at a cancer treatment center or (2) usual care plus additional support
|Design||Randomized controlled trial|
|Population||534 patients receiving care at an outpatient cancer center|
Primary: QOL, anxiety, depression
Secondary: symptom intensity, symptom distress, self-efficacy, barriers to managing symptoms
|Timeframe||10-week follow-up for primary outcomes|
This randomized controlled trial examined the effectiveness of the COPE intervention on helping patients with cancer manage symptoms at home. The research team compared patients who received the COPE intervention plus usual care with a group that received usual care plus extra support and also a group that received usual care only. Usual care included nurses teaching patients how to manage symptoms and whom to call if they needed help.
In the intervention group, patients learned the COPE problem-solving method to help assess and manage symptoms at home. To learn the method, patients watched a video, received a COPE manual, and had three individual, in-person sessions and two follow-up phone calls with trained staff. Staff encouraged patients to keep a daily symptom diary.
In the extra support group, patients received the same number of supportive visits and phone calls as the COPE group but did not learn the COPE intervention content. The study included this comparison group to see if differences found were due to the COPE content or the extra support the COPE group received.
The study included 534 patients receiving care at an outpatient cancer center in Florida. Patients were starting cancer treatment and reported at least two cancer symptoms with moderate to severe levels of intensity, distress, or interference with their daily life. Of these patients, 89% were white. The average patient age was 58, and 57% were female.
The research team collected self-reported patient data in person and by phone at baseline and again at 4, 8 and 10 weeks about QOL, depression, and anxiety. The team also collected information about symptoms, self-efficacy, and barriers to managing symptoms weekly for 10 weeks.
An advisory committee of patients and a physician gave input during the study. Patients gave feedback on the COPE materials.
The three groups did not differ significantly in QOL, anxiety, or depression.
Symptom intensity decreased significantly more over time for the COPE group compared with the usual care group (p=0.03), but not significantly more than the extra support group. The three groups did not differ significantly on measures of symptom distress, self-efficacy, or barriers to managing symptoms.
This study did not measure participants’ engagement with, or retention of, the COPE content. Lack of engagement or retention may have affected the results. Most patients in this study were white and all were receiving care at one cancer center, limiting the generalizability of findings.
Conclusions and Relevance
The COPE intervention did not improve patient’s QOL or mental health.
Future Research Needs
Future studies could examine other interventions to help patients with cancer manage symptoms at home, or if changes in the timing or number of COPE sessions could improve its effectiveness.
Final Research Report
View this project's final research report.
Related Journal Citations
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. The comments and responses included the following:
- Reviewers noted that the report referred to subgroup analyses based on cancer types that could not be conducted, due to limited recruitment of patients with certain cancer types. Reviewers asked the researchers to provide additional information about the different cancer types they had planned on including and why. The researchers responded by removing all reference to subgroup analyses by cancer type, saying that these analyses were not in the original study aims.
- The reviewers said data collection time points were not clear and the analyses did not account for varying time points in intervention exposure. The researchers said they delivered interventions in face-to-face meetings during regularly scheduled visits to the cancer center. They stated that they did not collect data about the timing of these visits. They added a limitation to their discussion regarding the inability to adjust for differences in intervention exposure time points.
Conflict of Interest Disclosures
Study Registration Information
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