Набор скоро начнётся NCT07699991

A Navigation Program to Improve Survivorship Support Service Participation Among Non-metastatic Breast Cancer Survivors

Без фазы С лечением Anatomic Stage 0 Breast Cancer AJCC v8 Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Best Practice, Patient Navigation, Patient Navigation, Referral.
Кому может быть актуально: Состояния в реестре: Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8. Базовые параметры: от 18 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Implementation of a Navigation Program for Breast Cancer Survivors

Обзор

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.

Подробное описание

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.

Вмешательства

Другое Best Practice
Attend survivorship consultation
Поведенческое Patient Navigation
Receive patient navigator scheduling support
Поведенческое Patient Navigation
Attend patient navigator coaching sessions
Другое Referral
Receive survivorship referral
Другое Survey Administration
Ancillary studies

Первичные конечные точки

Referral rates (Aims 1 & 2) [Срок оценки: From 12 months prior to intervention (baseline) up to 12 months during the program]
Scheduling after referral (Aims 1 & 2) [Срок оценки: From 12 months prior to intervention (baseline) up to 12 months during the program]
Clinic attendance (Aims 1 & 2) [Срок оценки: From 12 months prior to intervention (baseline) up to 12 months during the program]

Вторичные конечные точки (4)

Proportion of eligible patients who consent and initiate sessions (Acceptance) [Срок оценки: Up to 12 months]
Change in patient-reported outcomes (PROMIS-10) [Срок оценки: Baseline to 90 days]
Subgroup referral and uptake patterns [Срок оценки: Up to 12 months]
Change in patient-reported outcomes (BSES) [Срок оценки: Baseline to 90 days]

Критерии участия

Критерии включения

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