Patient Priorities for Survivorship Care in Older Breast Cancer Survivors

Обзор

The objective of this study is to adapt the Patient Priorities Care (PPC) framework to breast cancer survivorship via a user-centered approach, through an iterative process in which patients and their physicians help to refine and modify the intervention. A second objective is to evaluate the feasibility and effectiveness of the adapted PPC framework in breast cancer survivorship for older adults.

Подробное описание

In the proposed project, we will use a Patient Priorities Care framework to explore older breast cancer survivors' priorities and health care preferences for high-quality breast cancer survivorship. The framework will include two components: (1) a health priorities identification session with a facilitator, and (2) an encounter with the oncology provider to discuss changes in the patient's care plan to align it with his/her priorities. Our overall hypothesis is that prioritizing patients' priorities is feasible and facilitates individualized survivorship care for older women with breast cancer and multiple chronic conditions. An advisory panel composed of oncologists, geriatricians, and patient advocates will provide regular feedback throughout the refinement and adaptation of the Patient Priorities Care framework to the breast cancer survivorship context and engage in an iterative process of development. After incorporating feedback from the stakeholder panel to create an adapted version of the framework, we will carry out a randomized quality improvement project with the objective of evaluating the feasibility of using the framework in the context of breast cancer survivorship and provide empirical estimates of treatment effect sizes by measuring treatment burden and quality of life at 3 months, adherence to basic and priorities driven survivorship care recommendations at 12 months. Ultimately, the results of this project will provide initial direction for intended improvement, which will be verified in a larger, future trial.

Вмешательства

• Поведенческое Adapted Patient Priorities Care (PPC) approach
  Step 1 is a PPC facilitation encounter, at which the facilitator will help the participant identify patient priorities, such as clarifying values (what matters most); setting meaningful, specific, and realistic outcome goals; describing healthcare preferences (care that is helpful and/or burdensome) and tradeoffs; and discussing priorities with clinicians. The participant's healthcare priorities are then documented and transmitted to clinicians, in order to facilitate changes in the patient's ca
• Другое Usual Care
  Usual care for breast cancer survivorship includes regular visits with the oncology provider and yearly mammograms for surveillance.

Первичные конечные точки

• Treatment burden as assessed by the treatment burden questionnaire (TBQ) [Срок оценки: baseline]
• Treatment burden as assessed by the treatment burden questionnaire (TBQ) [Срок оценки: 3 months]
• Treatment burden as assessed by the treatment burden questionnaire (TBQ) [Срок оценки: 6 months]
• Health status as assessed by the Functional Assessment of Cancer Therapy - Breast (FACT-B) [Срок оценки: baseline]
• Health status as assessed by the Functional Assessment of Cancer Therapy - Breast (FACT-B) [Срок оценки: 3 months]
• Health status as assessed by the Functional Assessment of Cancer Therapy - Breast (FACT-B) [Срок оценки: 6 months]

Вторичные конечные точки (2)

• Number of participants who adhere to survivorship basic recommendations [Срок оценки: from baseline to 12 months]
• Number of participants who adhere to priorities-driven survivorship recommendations [Срок оценки: from baseline to 12 months]

Критерии участия

Критерии включения

• able to write and speak English
• Stage DCIS/I/II/III breast cancer diagnosis
• 3 months from active cancer therapy (including first or second-line treatment chemotherapy, radiation and/or surgery, or multimodal treatment) up to 10 years since completing treatment
• ≥3 documented comorbidities by chart review, or taking ≥10 medications, have ≥ 1 hospitalization over the past year, ≥ 2 emergency department visits over the past year, seen by > 2 specialists over the past year
• able to provide consent

Критерии исключения

• currently on active cancer therapy (including first or second-line treatment chemotherapy, radiation and/or surgery, or multimodal treatment)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 3 центра

• UT Physicians Center for Healthy Aging Bellaire — Bellaire
• UT Physicians Family Medicine Bayshore — Houston
• Memorial Hermann Cancer Center — Houston

Идентификаторы

NCT: NCT06478589 · HSC-MS-23-0591 · K12TR004908-02 · 1R03AG089057-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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