NCT00821288

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

June 19, 2017

Status Verified

June 1, 2017

Enrollment Period

4.3 years

First QC Date

January 12, 2009

Last Update Submit

June 15, 2017

Conditions

Breast Neoplasm

Keywords

cancer survivorshipsurvivorship prescriptioncancer related anxiety

Outcome Measures

Primary Outcomes (1)

  • Change in FACIT-TS questionnaire score

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

    Baseline, 6 months

Study Arms (2)

Survivorship Intervention

EXPERIMENTAL

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

Behavioral: Survivorship Intervention

Facing Forward

ACTIVE COMPARATOR

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

Interventions

Survivorship InterventionBEHAVIORAL

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).

Also known as: Survivorship Prescription
Survivorship Intervention
Facing ForwardBEHAVIORAL

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.

Also known as: Life after Cancer Treatment manual
Facing Forward

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia Unviersity Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

  • 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.

    PMID: 23542954DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Dawn L Hershman, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine & Epidemiology

Study Record Dates

First Submitted

January 12, 2009

First Posted

January 13, 2009

Study Start

July 1, 2007

Primary Completion

October 1, 2011

Study Completion

May 1, 2013

Last Updated

June 19, 2017

Record last verified: 2017-06

Locations

US(1)