College of Nursing > Faculty Funded Research
Dr. Susan C. McMillan (Principal Investigator)
PATIENT OUTCOMES OF A SELF-CARE MANAGEMENT APPROACH TO CANCER SYMPTOMS: A CLINICAL TRIAL
Start Date: August 1, 2013
End Date: September 30, 2016
Project Summary:
Regardless of the treatments they undergo, cancer patients endure a variety of difficult symptoms throughout their disease experience with averages ranging from seven to 14 symptoms per patient. Cancer-related symptoms, especially when symptoms are very intense, distressing, frequent, or interfere with daily activities, can lead to depression, anxiety, and diminished quality of life. Improving cancer patients’ ability to self-manage difficult symptoms has the potential to diminish patient suffering, improve quality of life, and decrease emergency room visits and associated healthcare costs.
We propose to test a brief and effective intervention with patients seen in a cancer center, with the goal of teaching patients symptom management skills for self-identified symptoms of highest priority to patients. The proposed randomized clinical trial will test the efficacy of the COPE intervention with patients with symptoms of moderate to high intensity, distress, frequency, or interference with their lives as a result of their cancer. We will include 300 patients from a large comprehensive cancer center with large numbers of outpatients with breast, colorectal, lung, and prostate cancers. After consenting, patients will be randomly assigned to one of three groups. Group III will receive the COPE intervention plus usual care. This group will receive three individual intervention sessions.
During the first intervention visit at the cancer center, this group will be taught the COPE intervention in a session focusing on the patient's self-identified most bothersome symptom. Role modeling and additional instruction will be provided via video, and patients will receive the Home Care Guide for Cancer and a copy of the video to take home. Two subsequent visits with the patient during regularly scheduled clinic visits will reinforce the principles of COPE and the use of the home care guide, and will help patients apply this approach to managing other symptoms.
In addition, they will get two phone calls encouraging them to apply COPE principles. Group II will receive three supportive visits from the research team at the cancer center and subsequent meetings during clinic visits, plus two subsequent supportive telephone calls, matched for time with the COPE group. Group I, the control group receiving usual care, will receive no additional attention from our interventionists. Data will be collected weekly for nine weeks about symptoms (intensity, frequency, interference, appraisal of distress), beliefs in their ability to self-manage symptoms, and barriers to self-management. Quality of life, anxiety, and depression will be assessed at baseline and weeks 4, 8, and 12. We predict that the COPE group will show significant improvement in depression, anxiety, quality of life, symptom intensity, distress, frequency and interference, self-management, and perceived barriers to care, as well as decreased use of healthcare resources, such as the emergency room, compared with the two control groups.