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

NCT01734499 | Completed

• 1 other identifier: A12-3719
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast cancer; Survivorship; Coping; Quality of Life

Outcome Measures

Primary Outcomes (5)

• Quality of Life Questionnaire

  Baseline

• Quality of Life Questionnaire

  change from Baseline and at 6 months

• Quality of Life Questionnaire

  change from Baseline and at 12 months

• Quality of Life Questionnaire

  change from Baseline and at 18 months

• Quality of Life Questionnaire

  change from Baseline and at 24 months

Study Arms (2)

Coping Class

EXPERIMENTAL

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; Behavioral: FACT-B Quality of Life

Standard of Care

ACTIVE COMPARATOR

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; Behavioral: FACT-B Quality of Life

Interventions

Coping Class BEHAVIORAL

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.

Coping Class

Standard of Care BEHAVIORAL

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.

Standard of Care

FACT-B Quality of Life BEHAVIORAL

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).

Coping Class; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Amarillo, Texas, 79106, United States

Location

Related Publications (31)

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Related Links

• United States Cancer Statistics: 1999-2005 Incidence and Mortality Web-based Report.
• Change Cycle

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Rakhshanda L Rahman, MD

  Texas Tech University Health Sciences Center-Amarillo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2012
• First Posted: November 27, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 21, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)