Patient Priorities for Survivorship Care in Older Breast Cancer Survivors
NCT Number: NCT06478589
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Breast Cancer Survivorship
Interventions: BEHAVIORAL: Adapted Patient Priorities Care (PPC) approach|OTHER: Usual Care
Sponsor: The University of Texas Health Science Center, Houston
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Sex: FEMALE
Age: OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10-01
Completion Date: 2027-06-01
Locations: The University of Texas Health Science Center at Houston, Houston, Texas, 77006, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Number of participants who adhere to survivorship basic recommendations, 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)., from baseline to 12 months|Number of participants who adhere to priorities-driven survivorship recommendations, 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., from baseline to 12 months