Recruiting
Phase 2

Patient Priorities Care

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06478589

Conditions

Breast Cancer Survivorship

Eligibility Criteria

Sex: Female

Age: 65 - 70+

Healthy Volunteers: Not accepted

Interventions

Adapted Patient Priorities Care (PPC) approach

Usual Care

Study Details

Brief summary:

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.

Conditions

Breast Cancer Survivorship

Study ID

NCT06478589

Start date

Jan 2, 2025

Status verified date

Aug, 2025

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 65 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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

active comparator: Usual Care

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

Interventions

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.

Usual Care

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Dana E. Giza, MD

(713) 500-6087Dana.E.Giza@uth.tmc.edu

Locations

UT Physicians Center for Healthy Aging Bellaire

Recruiting

Bellaire, Texas, United States, 77401

Contacts

Justun Holder

713-500-9438Justun.B.Holder@uth.tmc.edu

UT Physicians Family Medicine Bayshore

Recruiting

Houston, Texas, United States, 77006

Contacts

Justun Holder, RC III

713-500-9438Justun.B.Holder@uth.tmc.edu

Principal Investigator:

Dana E Giza, MD

Memorial Hermann Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Justun Holder, RC III

713-500-9438Justun.B.Holder@uth.tmc.edu

Principal Investigator:

Dana E Giza, MD

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Aug 12, 2025

Last verified

Aug, 2025

Keywords

  • Patient priorities
  • Survivorship Care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-08-12.