Ignite Creation Date:
2024-05-06 @ 3:25 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02288169
Status:
COMPLETED
Last Update Posted:
2017-01-05
First Post:
2014-11-06
Brief Title:
Patient Outcomes of a Self-care Management Approach to Cancer Symptoms A Clinical Trial
Sponsor:
University of South Florida
Organization:
University of South Florida
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None