Skip to main content
OpenTrials
Completed

NCT Number: NCT00821288

Post-treatment Care of Breast Cancer Survivors

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Columbia Unviersity Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Survivorship Intervention

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).

Other names: Survivorship Prescription

Facing Forward

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.

Other names: Life after Cancer Treatment manual

Primary outcomes

  1. Change in FACIT-TS questionnaire score

    Time frame: Baseline, 6 months

    This is designed to measure change in positive health related behavior.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Susan G. Komen Breast Cancer Foundation

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2013
First posted
Jan 13, 2009
Registry last updated
Jun 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.