Clinical trial NCT06478589: Patient Priorities for Survivorship Care in Older Breast Cancer Survivors
Official title: Patient Priorities for Survivorship Care in Older Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Survivorship
Keywords: Patient priorities
Survivorship Care
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
name: National Institute on Aging (NIA)
First posted: 2024-06-27
Enrollment: 120
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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)

Primary outcomes:
measure: Treatment burden as assessed by the treatment burden questionnaire (TBQ)
timeFrame: baseline
measure: Treatment burden as assessed by the treatment burden questionnaire (TBQ)
timeFrame: 3 months
measure: Treatment burden as assessed by the treatment burden questionnaire (TBQ)
timeFrame: 6 months
measure: Health status as assessed by the Functional Assessment of Cancer Therapy - Breast (FACT-B)
timeFrame: baseline
measure: Health status as assessed by the Functional Assessment of Cancer Therapy - Breast (FACT-B)
timeFrame: 3 months
measure: Health status as assessed by the Functional Assessment of Cancer Therapy - Breast (FACT-B)
timeFrame: 6 months
Secondary outcomes:
measure: Number of participants who adhere to survivorship basic recommendations
timeFrame: from baseline to 12 months
measure: Number of participants who adhere to priorities-driven survivorship recommendations
timeFrame: from baseline to 12 months
Other outcomes:
Locations:
city: Bellaire
country: United States
facility: UT Physicians Center for Healthy Aging Bellaire
state: Texas
city: Houston
country: United States
facility: UT Physicians Family Medicine Bayshore
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Cancer Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Dana E. Giza, MD
role: PRINCIPAL_INVESTIGATOR
References: