Clinical trial NCT00821288: Post-treatment Care of Breast Cancer Survivors
Official title: Post-treatment Care of Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm
Keywords: cancer survivorship
survivorship prescription
cancer related anxiety
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Susan G. Komen Breast Cancer Foundation
First posted: 2009-01-13
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in FACIT-TS questionnaire score
timeFrame: Baseline, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia Unviersity Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Dawn L Hershman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hershman DL, Greenlee H, Awad D, Kalinsky K, Maurer M, Kranwinkel G, Brafman L, Jayasena R, Tsai WY, Neugut AI, Crew KD. Randomized controlled trial of a clinic-based survivorship intervention following adjuvant therapy in breast cancer survivors. Breast Cancer Res Treat. 2013 Apr;138(3):795-806. doi: 10.1007/s10549-013-2486-1. Epub 2013 Mar 31.