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Post-treatment Care of Breast Cancer Survivors


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Neoplasm

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Trial Information

Post-treatment Care of Breast Cancer Survivors


More than 2 million women living in the United States today are breast cancer survivors.
Limited data exist on the experiences of women during the critical transitional period
between the end of primary treatment and survivorship. Minorities are typically
underrepresented in most studies that examined the quality of life and psychosocial
functioning of cancer survivors, and this is especially true of non-English speaking
minority populations.

The proposed investigation is a randomized prospective evaluation of a Survivorship
Intervention in improving the quality of care, treatment satisfaction and understanding of
care in Latina and Caucasian breast cancer survivors treated in an urban academic medical
center. We will recruit 120 patients (60 Hispanic and 60 non-Hispanic) within 4 weeks of
completing their last definitive breast cancer therapy (radiation therapy or chemotherapy).
Subjects will complete self administered baseline and follow-up questionnaires 3 months
after intervention. Following baseline evaluation, patients will review written information
for follow-up care of cancer survivors - Facing Forward: Life after Cancer Treatment and
undergo a comprehensive consultation in a survivorship clinic where an individualized report
including a treatment summary, surveillance recommendations, risk for late-effects, cancer
screening recommendations, genetic risk, and life style recommendations will be generated
and provided to the patient and physician. Patients will be re-assessed 3 months after the
intervention. Cancer therapy related symptoms, understanding of the recommended treatment
plan, treatment satisfaction, and the psychosocial impact of being a cancer survivor will be
evaluated, and assessed in relation to ethnicity (Hispanic vs non-Hispanic), primary
language, literacy and socioeconomic status. We hypothesize that patients will differ in
rates of cancer therapy related symptoms, understanding of the recommended treatment plan,
treatment satisfaction, and the psychosocial impact of being a cancer survivor in relation
to ethnicity (Hispanic vs non-Hispanic), primary language, literacy and socioeconomic
status.

We also hypothesize that the intervention will improve patents understanding of the
recommended treatment plan, treatment satisfaction and long term risk. We believe in the
long-term this Survivor-ship Intervention will have a positive impact on follow-up and
surveillance guidelines, adherence to standard cancer screening, and understanding of
lifestyle modification recommendations (low fat diet/exercise).


Inclusion Criteria:



- Participants will be screened for the following inclusion criteria:

- Age >18 years

- History of stage 0, I, II, or IIIa breast cancer and no evidence of recurrent disease

- Within 6 weeks of completion of breast cancer therapy (Surgery, Radiation or
Chemotherapy)

- Caucasian and/or Hispanic (English or Spanish-speaking)

- Willing to undergo a 1 hr cancer survivorship evaluation

Exclusion Criteria:

- Patients with the following active conditions or behaviors will be excluded from
participation:

- Evidence of recurrent or metastatic breast cancer

- Patients who have received surgery only with no adjuvant therapy

- Uncontrolled or significant psychiatric illness/social situations that would preclude
completion of questionnaire or follow-up evaluation.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Outcome Measure:

Cancer related anxiety

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Dawn L Hershman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University

Authority:

United States: Institutional Review Board

Study ID:

AAAC5741

NCT ID:

NCT00821288

Start Date:

June 2008

Completion Date:

September 2013

Related Keywords:

  • Breast Neoplasm
  • cancer survivorship
  • survivorship prescription
  • cancer related anxiety
  • Breast Neoplasms
  • Neoplasms

Name

Location

Columbia Unviersity Medical CenterNew York, New York  10032