Breast Cancer Clinical Trial

The Change Cycle Intervention for Improving Quality of Life in Breast Cancer Survivors

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.

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Full 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 survivors.Consequently, 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: (1)clinical 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.

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Eligibility Criteria

Inclusion Criteria:

female
18 years old or older
established diagnosis of breast cancer
diagnosis from January 2010 onward
must be patient of Texas Tech University Health Sciences Center-Breast Center of Excellence
must agree to participate in study structure of randomization

Exclusion Criteria:

those who do not accept randomization
women with medical conditions that preclude them from attending the coping class
women with personal issues that preclude them from attending the coping class

Study is for people with:

Breast Cancer

Estimated Enrollment:

120

Study ID:

NCT01734499

Recruitment Status:

Completed

Sponsor:

Texas Tech University Health Sciences Center

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There is 1 Location for this study

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Texas Tech University Health Sciences Center
Amarillo Texas, 79106, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

120

Study ID:

NCT01734499

Recruitment Status:

Completed

Sponsor:


Texas Tech University Health Sciences Center

How clear is this clinincal trial information?

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