Patient Priorities for Survivorship Care in Older Breast Cancer Survivors

NCT06478589 | Recruiting Phase 2

• 3 other identifiers: HSC-MS-23-0591K12TR004908-021R03AG089057-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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

Keywords

Patient priorities; Survivorship Care

Outcome Measures

Primary Outcomes (6)

• 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.

  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

Secondary Outcomes (2)

• Number of participants who adhere to survivorship basic recommendations

  from baseline to 12 months

• Number of participants who adhere to priorities-driven survivorship recommendations

  from baseline to 12 months

Study Arms (2)

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

Behavioral: Adapted Patient Priorities Care (PPC) approach; Other: Usual Care

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

Other: Usual Care

Interventions

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.

Adapted Patient Priorities Care (PPC) approach plus Usual Care

Usual Care OTHER

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

Adapted Patient Priorities Care (PPC) approach plus Usual Care; Usual Care

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• able to write and speak English
• Stage DCIS/I/II/III breast cancer diagnosis
• 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

You may not qualify if:

• currently on active cancer therapy (including first or second-line treatment chemotherapy, radiation and/or surgery, or multimodal treatment)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (3)

UT Physicians Center for Healthy Aging Bellaire

Bellaire, Texas, 77401, United States

RECRUITING

UT Physicians Family Medicine Bayshore

Houston, Texas, 77006, United States

RECRUITING

Memorial Hermann Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Study Officials

• Dana E. Giza, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana E. Giza, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 22, 2024
• First Posted: June 27, 2024
• Study Start: January 2, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)