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NCT02288169 · ClinicalTrials.gov registry record · NA
Patient Outcomes of a Self-care Management Approach to Cancer Symptoms: A Clinical Trial
A NA study, sponsored by University of South Florida.
- Completed
- Registry status
- NA
- Development phase
- 515
- Enrollment target
NCT02288169 is a NA study that has completed, run by University of South Florida. The registered enrollment target is 515 participants.
The verdict
NCT02288169, a NA study, has completed, sponsored by University of South Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 515 participants
- Enrollment target
Study Summary
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 gr
Interventions
- BEHAVIORAL COPE
- BEHAVIORAL Support/Attention Control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 515 participants |
| Start Date | 2013-09 |
| Est. Completion | 2016-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02288169
The ClinicalTrials.gov registry entry for NCT02288169 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 515 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of South Florida, which has 252 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which COPE is the first listed.
NCT02288169 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02288169 about?
NCT02288169 is a clinical study titled "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 depr...
What is the current status of trial NCT02288169?
This trial is currently completed. It is a NA study. The enrollment target is 515 participants. The study started on 2013-09. Estimated completion is 2016-07.
What interventions are being tested in trial NCT02288169?
The interventions under investigation include: COPE (BEHAVIORAL), Support/Attention Control (BEHAVIORAL).
Who is sponsoring clinical trial NCT02288169?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
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