NCT01734499

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Texas Tech University Health Sciences Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Coping Class	A 4-hour structured program which will be offered once a month as the "Coping Class" by a certified facilitator of "The Change Cycle." The coping class uses standardized materials and skills training. Standardized materials for the intervention arm will include "Change Moves Me" Participant's Guide/Journal, Locator Assessment Profile, The Change Cycle Color Model, and class evaluation. The structure of the class includes a profile of each stage to gain perspective and understanding, teaching personal change skills for each stage and a primary focus for movement to the next stage. The overall design follows an "act as if" philosophy, guiding participants through each stage of The Change Cycle, irrespective of which stage they are actually in.
BEHAVIORAL	Standard of Care	Standard of Care. Three components of this: (1)Surveillance Program: all patients diagnosed with breast cancer are seen every six months for the first two years and yearly thereafter to rule out disease recurrence by history and physical exam at each visit in addition to the annual mammogram. (2)Local support groups centered at community cancer centers. These are generally attended by 12-16 women monthly; all breast cancer patients receive the information about these groups. Associated with these programs, some classes are offered sporadically in nutrition, and exercise. (3)Comprehensive Postoperative Rehabilitation which offers physical and occupational rehabilitation to all women, thus provides prevention and treatment of lymphedema and monitored shoulder range of motion.
BEHAVIORAL	FACT-B Quality of Life	The FACT-B Quality of Life is a 44-item instrument that was developed by combining nine breast cancer-specific QL items with the FACT general QL instrument. The FACT-B consists of the following subscales: physical wellbeing (PWB), functional wellbeing (FWB), emotional wellbeing (EWB), social/family wellbeing (SWB), and breast cancer specific concerns (BCS).

Timeline

• Start date: 2012-10-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2012-11-27
• Last updated: 2016-04-21

Locations

1 site across 1 country: United States