Clinical trial NCT01734499: The Change Cycle Intervention for Improving Quality of Life in Breast Cancer Survivors
Official title: The Change Cycle Intervention for Improving Quality of Life in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Survivorship
Coping
Quality of Life
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

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

Primary outcomes:
measure: Quality of Life Questionnaire
timeFrame: Baseline
measure: Quality of Life Questionnaire
timeFrame: change from Baseline and at 6 months
measure: Quality of Life Questionnaire
timeFrame: change from Baseline and at 12 months
measure: Quality of Life Questionnaire
timeFrame: change from Baseline and at 18 months
measure: Quality of Life Questionnaire
timeFrame: change from Baseline and at 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amarillo
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center-Amarillo
name: Rakhshanda L Rahman, MD
role: PRINCIPAL_INVESTIGATOR
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