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Набор по приглашению NCT05400941

Aim 3, Adapting and Implementing Evidence-based Breast Cancer Follow-up in Primary Care

Без фазы С лечением Cancer, Breast Health Care Utilization

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: Practice Led Intervention.
Кому может быть актуально
Состояния в реестре: Cancer, Breast, Health Care Utilization. Базовые параметры: от 21 лет · Все.
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

Adapting and Implementing Evidence-based Breast Cancer Follow-up in Primary Care

Обзор

This mixed methods study evaluates the effectiveness of an organizational intervention to enhance implementation of strategies to increase breast cancer survivorship symptom and risk management.

Подробное описание

Aim 3 is a hybrid type 1 effectiveness-implementation cluster randomized study with a waitlist control in 26 primary care practices. This study uses a tailored combination of practice facilitation, expert consultation, collaborative learning events, and audit and feedback as intervention strategies, and a mixed-methods comparative case study learning evaluation for primary care practices to adapt priority recommendations of evidence-based activities for breast cancer survivorship care. Intervention effectiveness will be assessed in two groups of clinics: 13 cases that will receive the implementation intervention and 13 waitlist controls. Impact of this implementation will be measured using mixed methods to assess Exploration, Preparation, Implementation and Sustainment factors related to how organizational and contextual variables affect adoption, implementation and early sustainability for provision of follow-up care, symptom, and risk management activities at 6 and 12 months post implementation. Aim 3 surveys 20 clinicians and staff members from 26 intervention practices (n=520) and conducts key informant interviews with 5 health care team members (who have participated in the survey; n=130) and 15 breast cancer survivors per practice (n=390; 5 per assessment point at baseline, 6 months and 12 months post intervention). Medical records of 20 patients with a history of breast cancer per practice per assessment point at baseline, 6 months and 12 months post intervention will be randomly selected for review (N=1,560) to assess and compare comprehensive breast cancer follow-up care outcomes. Sustainment will be measured through continued monitoring of the medical records for the 13 initial intervention practices at 18 and 24 months (N=520).

Вмешательства

  • Поведенческое Practice Led Intervention
    This is a quality improvement intervention that includes learning collaboratives, practice facilitation, expert consultation and audit and feedback.

Первичные конечные точки

  • Change in Comprehensive Breast Cancer Follow-up Care [Срок оценки: Repeated measures at baseline, 6 months, 12 months, 18 months and 24 months]

Критерии участия

Критерии включения

  • Self-identification as a staff member or patient who has had breast cancer in a participating practice

Критерии исключения

  • Unable to speak, understand and/or read English
  • Unable to provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • Rutgers University — New Brunswick

Публикации

  • Fadem SJ, Hudson SV, Crabtree BF, Howard J, Hemler JR, Ferrante J, Mikesell L, April-Sanders AK, Bator A, O'Malley DM. Using co-design to develop actionable strategies to identify and follow-up on breast cancer survivors in primary care. BMC Health Serv Res. 2026 Apr 18;26(1):777. doi: 10.1186/s12913-026-14538-7. PMID 42001107
  • Fadem SJ, Maniaci A, Devine KA, O'Malley DM, Hemler JR, Holover G, Hudson SV, Crabtree BF. "I had to work it out for myself": opportunities for primary care to fill a void for early-onset breast cancer survivors. J Cancer Surviv. 2026 Mar 18:10.1007/s11764-026-02001-9. doi: 10.1007/s11764-026-02001-9. Online ahead of print. PMID 41844926
  • Fadem SJ, Crabtree BF, O'Malley DM, Mikesell L, Ferrante JM, Toppmeyer DL, Ohman-Strickland PA, Hemler JR, Howard J, Bator A, April-Sanders A, Kurtzman R, Hudson SV. Adapting and implementing breast cancer follow-up in primary care: protocol for a mixed methods hybrid type 1 effectiveness-implementation cluster randomized study. BMC Prim Care. 2023 Nov 9;24(1):235. doi: 10.1186/s12875-023-02186-3. PMID 37946132

Идентификаторы

NCT: NCT05400941 · Pro2021000838 · R01CA257197

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗