Ignite Creation Date:
2024-05-06 @ 1:08 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01734499
Status:
COMPLETED
Last Update Posted:
2016-04-21
First Post:
2012-11-21
Brief Title:
The Change Cycle Intervention for Improving Quality of Life in Breast Cancer Survivors
Sponsor:
Texas Tech University Health Sciences Center
Organization:
Texas Tech University Health Sciences Center
Study Overview
Official Title:
The Change Cycle Intervention for Improving Quality of Life in Breast Cancer Survivors
Status:
COMPLETED
Status Verified Date:
2016-04
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:
CCIP
Brief Summary:
This study is proposed to assess long-term Quality of Life issues in breast cancer survivors by measuring the impact on the quality of life made by the structured Change Cycle Work Shop coping class as compared to current local standard of care programs It has been shown that breast cancer treatment can have long-term bio-psychosocial consequences Specific evidence-based interventions are needed to address Quality of Life concerns in order to improve the overall outcome of breast cancer and its treatment beyond the focus on mortality rate
Detailed Description:
Breast cancer is the most common cancer among North American women A combination of screening mammography and improvements in treatment has resulted in a substantial decrease in mortality which explains why more women diagnosed at a younger age are becoming long-term survivorsConsequently quality of life QL issues have become increasingly important in the contemporary multidisciplinary management of breast cancer Standard of car survivorship program has evolved over several years to include 3 facets 1clinical surveillance program to include routine follow up exams 2 local support group programs and 3 rehabilitation program offering physical and occupational rehab along with lymphedema prevention and treatment
Many studies have reported on successful interventions listed in our references with improvements in quality of life however the effects did not last long after intervention This has brought into question the real value of such interventions The proposed class will focus on teaching life skills that have shown long-lasting effect in the corporate world of change Thus our goal is to determine if the impact of the class will be similar in the healthcare arena specifically cancer survivorship Our last study on assessing quality of life revealed that patients were suffering deficits in quality of life specifically with regard to the emotional scale despite the standard of care approach available We therefore propose this intervention to be studied as proof of concept so that depending on the results of the proposed trial this class can become a routine part of the survivorship program
Many studies have reported on successful interventions listed in our references with improvements in quality of life however the effects did not last long after intervention This has brought into question the real value of such interventions The proposed class will focus on teaching life skills that have shown long-lasting effect in the corporate world of change Thus our goal is to determine if the impact of the class will be similar in the healthcare arena specifically cancer survivorship Our last study on assessing quality of life revealed that patients were suffering deficits in quality of life specifically with regard to the emotional scale despite the standard of care approach available We therefore propose this intervention to be studied as proof of concept so that depending on the results of the proposed trial this class can become a routine part of the survivorship program
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