Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06478589

Patient Priorities for Survivorship Care in Older Breast Cancer Survivors

Status
Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
120 (estimated)
Sponsor
The University of Texas Health Science Center, Houston · Academic / Other
Sex
Female
Age
65 Years – 100 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALAdapted Patient Priorities Care (PPC) approachStep 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.
OTHERUsual CareUsual care for breast cancer survivorship includes regular visits with the oncology provider and yearly mammograms for surveillance.

Timeline

Start date
2025-01-02
Primary completion
2026-12-01
Completion
2027-06-01
First posted
2024-06-27
Last updated
2025-08-12

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT06478589. Inclusion in this directory is not an endorsement.