Post-treatment Care of Breast Cancer Survivors

Columbia University

Status: Completed

Conditions: Breast Neoplasm

Treatments: Behavioral: Survivorship Intervention; Behavioral: Facing Forward

Study type: Interventional

Funder types: Other

Identifiers

NCT00821288

DISP0706868 (Other Grant/Funding Number)

AAAC5741

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 140 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Survivorship Intervention

Experimental group

Description:

Latina and Caucasian breast cancer survivors treated in an urban academic medical center receiving Survivorship Intervention

Treatment:

Behavioral: Survivorship Intervention

Facing Forward

Active Comparator group

Description:

Latina and Caucasian breast cancer survivors treated in an urban academic medical center receiving Survivorship Intervention Facing Forward: Life after Cancer Treatment manual

Treatment:

Behavioral: Facing Forward