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

Breast Cancer Clinical Trial

— CCIP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01734499
• Other study ID #: A12-3719
• Status: Completed
• Phase: N/A
• First received: November 21, 2012
• Last updated: April 19, 2016
• Start date: October 2012
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Texas Tech University Health Sciences Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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.
• 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).

Locations

Country	Name	City	State
United States	Texas Tech University Health Sciences Center	Amarillo	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center

Country where clinical trial is conducted

United States, 

References & Publications (31)

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www.changecycle.com

* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life Questionnaire		Baseline	No
Primary	Quality of Life Questionnaire		change from Baseline and at 6 months	No
Primary	Quality of Life Questionnaire		change from Baseline and at 12 months	No
Primary	Quality of Life Questionnaire		change from Baseline and at 18 months	No
Primary	Quality of Life Questionnaire		change from Baseline and at 24 months	No

External Links

•   Research Cancer Facts and Figures
•   State Cancer Profiles
•   United States Cancer Statistics: 1999-2005 Incidence and Mortality Web-based Report.