Patient Priorities for Survivorship Care in Older Breast Cancer Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adapted Patient Priorities Care (PPC) approach, Usual Care.
- Who it may be relevant to
- Registry conditions: Breast Cancer Survivorship. Basic parameters: 65 years — 100 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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.
Interventions
- Behavioral 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 - Other Usual Care
Usual care for breast cancer survivorship includes regular visits with the oncology provider and yearly mammograms for surveillance.
Primary outcome measures
- Treatment burden as assessed by the treatment burden questionnaire (TBQ) [Time frame: baseline]
- Treatment burden as assessed by the treatment burden questionnaire (TBQ) [Time frame: 3 months]
- Treatment burden as assessed by the treatment burden questionnaire (TBQ) [Time frame: 6 months]
- Health status as assessed by the Functional Assessment of Cancer Therapy - Breast (FACT-B) [Time frame: baseline]
- Health status as assessed by the Functional Assessment of Cancer Therapy - Breast (FACT-B) [Time frame: 3 months]
- Health status as assessed by the Functional Assessment of Cancer Therapy - Breast (FACT-B) [Time frame: 6 months]
Secondary outcome measures (2)
- Number of participants who adhere to survivorship basic recommendations [Time frame: from baseline to 12 months]
- Number of participants who adhere to priorities-driven survivorship recommendations [Time frame: from baseline to 12 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 3 centers
- UT Physicians Center for Healthy Aging Bellaire — Bellaire
- UT Physicians Family Medicine Bayshore — Houston
- Memorial Hermann Cancer Center — Houston
Identifiers
NCT: NCT06478589 · HSC-MS-23-0591 · K12TR004908-02 · 1R03AG089057-01