Post-treatment Care of Breast Cancer Survivors

Study Overview
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Brief Summary
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The overall goal of this proposal is to improve the post-treatment care of breast cancer survivors and to understand the barriers to optimal post-treatment care in Latina and Non-Hispanic women.

Detailed Description
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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. Patients will be recruited within 6 weeks of completing their last definitive breast cancer therapy (radiation or chemotherapy). Patients will complete self administered baseline and follow-up questionnaires. Following baseline evaluation patients will be randomized to receiving either written information for follow-up care of cancer survivors published by the National Cancer Institute (Facing Forward), or the Survivorship Intervention. Patients will not be aware that they are participating in a randomized intervention. After verbally agreeing to participate they will be randomized to group A or B and will receive the corresponding consent. Patients will be re-assessed 3 and 6 months after enrollment.

Official Title
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Post-treatment Care of Breast Cancer Survivors

Conditions
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Breast Neoplasm

Intervention / Treatment
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* Behavioral: Survivorship Intervention
* Behavioral: Facing Forward


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Survivorship Intervention<br>Latina and Caucasian breast cancer survivors treated in an urban academic medical center receiving Survivorship Intervention | Behavioral: Survivorship Intervention<br>* Survivorship Consultation is a one hour consultation in a survivorship clinic. The consultation will be performed by a nurse practitioner under the supervision of a medical oncologist. The consultation will result in a detailed written document outlining the individuals Survivorship Prescription including treatment summary, surveillance recommendations, risk for late-effects, cancer screening recommendations, genetic risk, and life style recommendations. This written document will be provided to the patient and her treating physician. In addition, referrals will be made to appropriate adjunct services as needed (e.g. psychologist, nutritionist, social worker).<br>* Other names: Survivorship Prescription;|
| Active Comparator: Facing Forward<br>Latina and Caucasian breast cancer survivors treated in an urban academic medical center receiving Survivorship Intervention Facing Forward: Life after Cancer Treatment manual | Behavioral: Facing Forward<br>* Facing Forward: Life after Cancer Treatment is a guide for people who were treated for cancer published by the NCI. It is a 24-page manual that summarized many key issues of interest to cancer survivors during the re-entry phase, and contains sections on medical care after treatment, symptoms after treatment, feelings after treatment, social relationships after cancer treatment, and dealing with practical matters such as insurance and employment. The manual is available in English and Spanish. This will be given at the time of registration and the table of contents will be reviewed with the patient.<br>* Other names: Life after Cancer Treatment manual;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FACIT-TS questionnaire score | This is designed to measure change in positive health related behavior. | Baseline, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer survivorship, survivorship prescription, cancer related anxiety