Patient Priorities for Survivorship Care in Older Breast Cancer Survivors
- Conditions
- Breast Cancer Survivorship
- Interventions
- Behavioral: Adapted Patient Priorities Care (PPC) approachOther: Usual Care
- Registration Number
- NCT06478589
- 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
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 120
- able to write and speak English
- Stage I/II/III breast cancer diagnosis
- within 3 months of active cancer therapy (including first or second-line treatment chemotherapy, radiation and/or surgery, or multimodal 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
- currently on active cancer therapy (including first or second-line treatment chemotherapy, radiation and/or surgery, or multimodal treatment)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adapted Patient Priorities Care (PPC) approach plus Usual Care Usual Care - Usual Care Usual Care - Adapted Patient Priorities Care (PPC) approach plus Usual Care Adapted Patient Priorities Care (PPC) approach -
- Primary Outcome Measures
Name Time Method Health status as assessed by the Functional Assessment of Cancer Therapy - Breast (FACT-B) 6 months 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.
Treatment burden as assessed by the treatment burden questionnaire (TBQ) 6 months 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.
- Secondary Outcome Measures
Name Time Method Number of participants who adhere to survivorship basic recommendations from baseline to 12 months Survivorship basic recommendations for breast cancer survivors, as recommended by the American Society of Clinical Oncology (ASCO) guidelines, include receiving a detailed cancer-related history and physical examination every 3-6 months for the first 3 years and every 6 to 12 months for the next 2 years, as well as having an annual mammogram (unilateral if for unilateral mastectomies or bilateral for patients with lumpectomies or other breast conserving strategies).
Number of participants who adhere to priorities-driven survivorship recommendations from baseline to 12 months Adherence to priorities-driven survivorship recommendations will focus on adherence to medications, self-management tasks, procedures, tests or referrals recommended during survivorship care based on patient's priorities.
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States