Patient Priorities for Survivorship Care in Older Breast Cancer Survivors

NCT ID: NCT06478589

Last Updated: 2025-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-02

Study Completion Date

2027-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer Survivorship

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Adapted Patient Priorities Care (PPC) approach plus Usual Care

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

Group Type EXPERIMENTAL

Adapted Patient Priorities Care (PPC) approach

Intervention Type 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.

Usual Care

Intervention Type OTHER

Usual care for breast cancer survivorship includes regular visits with the oncology provider and yearly mammograms for surveillance.

Usual Care

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

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Usual care for breast cancer survivorship includes regular visits with the oncology provider and yearly mammograms for surveillance.

Interventions

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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 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.

Intervention Type BEHAVIORAL

Usual Care

Usual care for breast cancer survivorship includes regular visits with the oncology provider and yearly mammograms for surveillance.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Dana Giza

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dana E. Giza, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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UT Physicians Center for Healthy Aging Bellaire

Bellaire, Texas, United States

Site Status RECRUITING

UT Physicians Family Medicine Bayshore

Houston, Texas, United States

Site Status RECRUITING

Memorial Hermann Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Dana E. Giza, MD

Role: CONTACT

(713) 500-6087

Facility Contacts

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Justun Holder

Role: primary

713-500-9438

Justun Holder, RC III

Role: primary

713-500-9438

Justun Holder, RC III

Role: primary

713-500-9438

Other Identifiers

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K12TR004908-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R03AG089057-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC-MS-23-0591

Identifier Type: -

Identifier Source: org_study_id

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