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Purpose

This clinical trial studies whether a navigation program improves survivorship support service participation among survivors of breast cancer that has not spread from where it first started (primary site) to other places in the body (non-metastatic). Advances in treatment have caused the number of breast cancer survivors to grow. As this number increases, there are reported unmet supportive care needs in this population, including psychological distress and limitations in physical functioning. To address these needs, many cancer centers offer programming on a variety of topics including psychological services, exercise counseling, and nutrition counseling. Research has shown that while interest in these survivorship programs is high, participation remains low, especially among minority women. Navigation is a healthcare service that is designed to guide a patient through the healthcare system and reduce barriers to timely screening, follow-up, diagnosis, treatment, and supportive care. The navigation program in this trial is specifically focused on helping breast cancer survivors schedule and attend survivorship consultation appointments as well as providing additional support to underserved/vulnerable patients. A navigation program may be effective in improving survivorship support service participation among non-metastatic breast cancer survivors.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • GENERAL INCLUSION (PRIMARY OBJECTIVE): Ages 18+ - GENERAL INCLUSION (PRIMARY OBJECTIVE): Diagnosed with non-metastatic breast cancer - GENERAL INCLUSION (PRIMARY OBJECTIVE): Received care at Stefanie Spielman Breast Center - COACHING INCLUSION (SECONDARY OBJECTIVE): Referred patients who fall under any of the following: - Black and/or Hispanic - Ages ≥ 70 - Reside in a ZIP code classified as rural by United States Department of Agriculture (USDA) Rural-Urban Commuting Area (RUCA) codes

Exclusion Criteria

  • Metastatic breast cancer at time of referral - Prisoners or individuals unable to consent - Non-English and non-Spanish speakers

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Supportive care (breast cancer survivor navigation program) 		Patients receive a referral to survivorship at James Cancer Supportive Care Clinic and attend a survivorship consultation visit consisting of standard survivorship care and referrals at baseline. Patients who do not schedule or cancel the survivorship consultation visit receive patient navigator support to help with scheduling. Following survivorship consult, underserved/vulnerable patients may attend five patient navigator coaching sessions over 90 days.
  • Other: Best Practice
    Attend survivorship consultation
    Other names:
    • standard of care
    • standard therapy
  • Behavioral: Patient Navigation
    Receive patient navigator scheduling support
    Other names:
    • Patient Navigator Program
  • Behavioral: Patient Navigation
    Attend patient navigator coaching sessions
    Other names:
    • Patient Navigator Program
  • Other: Referral
    Receive survivorship referral
    Other names:
    • Referred
  • Other: Survey Administration
    Ancillary studies

Recruiting Locations

Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Contact:
Bridget A. Oppong, MD, MPH
614-293-6408
bridget.oppong@osumc.edu

More Details

Status
Recruiting
Sponsor
Ohio State University Comprehensive Cancer Center

Study Contact

The Ohio State University Comprehensive Cancer Center
1-800-293-5066
OSUCCCClinicaltrials@osumc.edu

Detailed Description

PRIMARY OBJECTIVES: I. Increase the rate of referrals to survivorship support services among eligible breast cancer survivors by 50% within 12 months following implementation of a structured navigation program. (Aim 1) II. Reduce the rate of non-scheduled survivorship visits (defined as no appointment made within 30 days of referral) by 50% and increase the re-scheduling success rate among patients who initially cancel. (Aim 2) SECONDARY OBJECTIVE: I. Among patients identified as at-risk (minority race/ethnicity, rural residence, age ≥ 70), assess the uptake of coaching, and evaluate changes in self-efficacy scores before and after a 90-day navigation-based coaching intervention. (Aim 3) OUTLINE: Patients receive a referral to survivorship at James Cancer Supportive Care Clinic and attend a survivorship consultation visit consisting of standard survivorship care and referrals at baseline. Patients who do not schedule or cancel the survivorship consultation visit receive patient navigator support to help with scheduling. Following survivorship consult, underserved/vulnerable patients may attend five patient navigator coaching sessions over 90 days.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.