Patient Outcomes of a Self-care Management Approach to Cancer Symptoms: A Clinical Trial

Regardless of their treatment, cancer patients endure a variety of difficult symptoms during
their disease with averages ranging from 7 to 14 symptoms each. 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 their
ability to self-manage difficult symptoms has the potential to diminish suffering, improve
quality of life and decrease emergency room visits and associated costs. The investigators
propose to test a brief, effective intervention with outpatients in a cancer center, with the
goal of teaching patients symptom management skills for self-identified symptoms of highest
priority to patients. Objective: 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. Method: The
investigators will seek 300 completed subjects, outpatients with breast, colorectal, lung,
and prostate cancers. Patients will be randomized into three groups. Group III, the
experimental group, will receive usual care plus the COPE intervention. This group will
receive 3 individual intervention sessions. During the first intervention visit at the cancer
center, the COPE 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. Three 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 2 phone calls encouraging them to apply COPE. Group II, the attention control
group, will receive supportive visits from the research team at the cancer center and
subsequent meetings during clinic visits plus 2 subsequent supportive telephone calls,
matched for time with COPE participants. Group I, the control group receiving usual care,
will receive no additional attention from our interventionists. Data will be collected weekly
for 9 weeks about symptoms (intensity, frequency, interference, appraisal of distress),
self-efficacy, and barriers to self-management. Patient Outcomes: Quality of life, anxiety
and depression will be assessed at baseline and weeks 4, 8, and 12. The investigators predict
that the COPE group will show significant improvement in depression, anxiety, quality of
life, symptom intensity, distress, frequency and interference, self-efficacy, and perceived
barriers to care, as well as decreased utilization of health care resources compared with the
two control groups. Data will be analyzed using repeated measures multivariate analysis of
variance using a mixed model approach.