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Survivorship Care Planning for At Risk Breast Cancer Survivors: A Focus on Latina-, Asian- and European Americans


N/A
N/A
N/A
Not Enrolling
Female
Breast Cancer, Cancer Survivor

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Trial Information

Survivorship Care Planning for At Risk Breast Cancer Survivors: A Focus on Latina-, Asian- and European Americans


PRIMARY OBJECTIVES:

I. Test the effectiveness of the navigation intervention and survivorship care plan
(SCP)-breast cancer survivors (BCS) template booklet on accessing and adhering to SCP-BCS
guidelines compared to the control group receiving usual care and the SCP-BCS template
booklet.

SECONDARY OBJECTIVES:

I. Develop a clinically and psychosocially responsive SCP-breast cancer survivors (SCP-BCS)
template in English and English-Spanish adopted from American Society of Clinical Oncology
(ASCO)-SCP.

II. Assess the acceptability, utility and format preference (electronic vs paper) of the
SCP-BCS template.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive SCP-BCS template booklet and receive counseling sessions with a
patient navigator for 40 minutes twice weekly for 4 sessions.

ARM II: Participants receive SCP-BCS template booklet and receive standard follow-up care.

After completion so study treatment, participants are followed up at 6 and 12 months.


Inclusion Criteria:



- BCS who are 6-18 months post diagnosis (near active treatment completion) residing in
Southern California

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Proportion of BCS accessing a SCP from their oncology provider

Outcome Description:

Logistic regression will be used to compared the proportion between the treatment groups, by adjusting for demographic and medical covariates, and treatment site.

Outcome Time Frame:

Up to 12 months

Safety Issue:

No

Principal Investigator

Kimlin Ashing-Giwa

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center

Authority:

United States: Federal Government

Study ID:

12383

NCT ID:

NCT01824745

Start Date:

September 2013

Completion Date:

Related Keywords:

  • Breast Cancer
  • Cancer Survivor
  • Breast Neoplasms

Name

Location

City of Hope Medical CenterDuarte, California  91010