Results Summary

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.

Final Research Report

View this project's final research report.

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. 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

Project Information

Susan McMillan, NP, PhD
University of South Florida
Patient Outcomes of a Self-Care Management Approach to Cancer Symptoms: A Clinical Trial

Key Dates

May 2013
December 2018

Study Registration Information


Has Results
Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: April 11, 2024