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


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Quality of Life

Outcome Time Frame:

Baseline

Safety Issue:

No

Principal Investigator

Rakhshanda L Rahman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Texas Tech University Health Sciences Center-Amarillo

Authority:

United States: Institutional Review Board

Study ID:

Change Cycle Intervention

NCT ID:

NCT01734499

Start Date:

October 2012

Completion Date:

December 2014

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Survivorship
  • Coping
  • Quality of Life
  • Breast Neoplasms

Name

Location

Texas Tech University Health Sciences Center Lubbock, Texas  79430