Post-treatment Care of Breast Cancer Survivors

NCT ID: NCT00821288

Last Updated: 2017-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2013-05-31

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.

Conditions

Breast Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Survivorship Intervention

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

Group Type: EXPERIMENTAL

Survivorship Intervention

Intervention Type: BEHAVIORAL

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).

Facing Forward

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

Group Type: ACTIVE_COMPARATOR

Facing Forward

Intervention Type: BEHAVIORAL

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.

Interventions

Survivorship Intervention

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).

Intervention Type: BEHAVIORAL

Facing Forward

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Survivorship Prescription; Life after Cancer Treatment manual

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Susan G. Komen Breast Cancer Foundation

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Dawn L. Hershman

Associate Professor of Medicine & Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dawn L Hershman, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia Unviersity Medical Center

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23542954 (View on PubMed)

Other Identifiers

DISP0706868

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AAAC5741

Identifier Type: -

Identifier Source: org_study_id