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| ID | Type | Description | Link |
|---|---|---|---|
| K12TR004908-02 | U.S. NIH Grant/Contract | View source | |
| 1R03AG089057-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adapted Patient Priorities Care (PPC) approach plus Usual Care | Experimental | 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 |
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| Usual Care | Active Comparator | Older adults breast cancer survivors will have usual healthcare visits with the oncology/primary care physicians to discuss aspects of survivorship care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapted Patient Priorities Care (PPC) approach | Behavioral | 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 care plan to align it with his/her priorities. In step 2, the clinician considers patient's priorities and potential healthcare options (options might include starting or stopping treatments; adding or removing medications; ordering more or fewer tests; recommending or removing self-management tasks). In step 3, the clinician discusses care options with the participant, using strategies for aligning care with patient priorities. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment burden as assessed by the treatment burden questionnaire (TBQ) | The treatment burden questionnaire (TBQ) measures perceptions of burden of overall care (for example, medication taking, self monitoring, visits to the provider, tests, tasks to access and coordinate care). Total score ranges from 0 to 150, and a higher score indicates greater perceived burden. | baseline |
| Treatment burden as assessed by the treatment burden questionnaire (TBQ) | The treatment burden questionnaire (TBQ) measures perceptions of burden of overall care (for example, medication taking, self monitoring, visits to the provider, tests, tasks to access and coordinate care). Total score ranges from 0 to 150, and a higher score indicates greater perceived burden. | 3 months |
| Treatment burden as assessed by the treatment burden questionnaire (TBQ) | The treatment burden questionnaire (TBQ) measures perceptions of burden of overall care (for example, medication taking, self monitoring, visits to the provider, tests, tasks to access and coordinate care). Total score ranges from 0 to 150, and a higher score indicates greater perceived burden. | 6 months |
| Health status as assessed by the Functional Assessment of Cancer Therapy - Breast (FACT-B) | The Functional Assessment of Cancer Therapy- Breast (FACT-B) is a standardized approach to objectively evaluate and quantify the overall health status of patients with subscales measuring physical, social, emotional, and functional well-being. Total score ranges from 0 to 148, where a higher score indicates a better outcome. | baseline |
| Health status as assessed by the Functional Assessment of Cancer Therapy - Breast (FACT-B) | The Functional Assessment of Cancer Therapy- Breast (FACT-B) is a standardized approach to objectively evaluate and quantify the overall health status of patients with subscales measuring physical, social, emotional, and functional well-being. Total score ranges from 0 to 148, where a higher score indicates a better outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who adhere to survivorship basic recommendations | Survivorship basic recommendations for breast cancer survivors, as recommended by the American Society of Clinical Oncology (ASCO) guidelines, include receiving a detailed cancer-related history and physical examination every 3-6 months for the first 3 years and every 6 to 12 months for the next 2 years, as well as having an annual mammogram (unilateral if for unilateral mastectomies or bilateral for patients with lumpectomies or other breast conserving strategies). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dana E. Giza, MD | Contact | (713) 500-6087 | Dana.E.Giza@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Dana E. Giza, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Physicians Center for Healthy Aging Bellaire | Recruiting | Bellaire | Texas | 77401 | United States |
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| Usual Care | Other | Usual care for breast cancer survivorship includes regular visits with the oncology provider and yearly mammograms for surveillance. |
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| 3 months |
| Health status as assessed by the Functional Assessment of Cancer Therapy - Breast (FACT-B) | The Functional Assessment of Cancer Therapy- Breast (FACT-B) is a standardized approach to objectively evaluate and quantify the overall health status of patients with subscales measuring physical, social, emotional, and functional well-being. Total score ranges from 0 to 148, where a higher score indicates a better outcome. | 6 months |
| from baseline to 12 months |
| Number of participants who adhere to priorities-driven survivorship recommendations | Adherence to priorities-driven survivorship recommendations will focus on adherence to medications, self-management tasks, procedures, tests or referrals recommended during survivorship care based on patient's priorities. | from baseline to 12 months |
| UT Physicians Family Medicine Bayshore | Recruiting | Houston | Texas | 77006 | United States |
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| Memorial Hermann Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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