Patient Priorities for Survivorship Care in Older Breast Cancer Survivors

The University of Texas System (UT)

Status and phase: Enrolling; Phase 2

Conditions: Breast Cancer Survivorship

Treatments: Behavioral: Adapted Patient Priorities Care (PPC) approach; Other: Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06478589

K12TR004908-02 (Other Grant/Funding Number)

HSC-MS-23-0591

1R03AG089057-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 65 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Adapted Patient Priorities Care (PPC) approach plus Usual Care

Experimental group

Description:

Older adults breast cancer survivors will have a visit with a facilitator to discuss about their health priorities for breast cancer survivorship care prior to their usual visit with the oncology/primary care physicians to discuss about aspects of survivorship care

Treatment:

Other: Usual Care

Behavioral: Adapted Patient Priorities Care (PPC) approach

Usual Care

Active Comparator group

Description:

Older adults breast cancer survivors will have usual healthcare visits with the oncology/primary care physicians to discuss aspects of survivorship care

Treatment:

Other: Usual Care