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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01734499
First received: November 21, 2012
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: Coping Class
Behavioral: Standard of Care
Behavioral: FACT-B Quality of Life

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Change Cycle Intervention for Improving Quality of Life in Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: change from Baseline and at 6 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: change from Baseline and at 12 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: change from Baseline and at 18 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: change from Baseline and at 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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." Quality of Life survey completed at 5 time points after informed consent.
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: 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).
Active Comparator: Standard of Care
Standard of Care. Three components of this: (1)Surveillance Program, (2)Local support groups centered at community cancer centers, (3)Comprehensive Postoperative Rehabilitation which offers physical and occupational rehabilitation.Quality of Life surveys completed at 5 time points after informed consent.
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).

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) rehabiliation 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01734499

Locations
United States, Texas
Texas Tech University Health Sciences Center
Amarillo, Texas, United States, 79106
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
Principal Investigator: Rakhshanda L Rahman, MD Texas Tech University Health Sciences Center-Amarillo
  More Information

Additional Information:
Publications:
Borelli B. The assessment, monitoring, and enhancement of treatment fidelity in public health clinical trials. J Pub Health Dent 2011; 71: S52-63
Trotter R. The Mystery of Mastery. Psychology Today 1986; 20(7): 32-8

Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01734499     History of Changes
Other Study ID Numbers: Change Cycle Intervention
Study First Received: November 21, 2012
Last Updated: May 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Tech University Health Sciences Center:
Breast cancer
Survivorship
Coping
Quality of Life

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 01, 2014