About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
currently on active cancer therapy (including first or second-line treatment chemotherapy, radiation and/or surgery, or multimodal treatment)
Trial design
Parallel
Treatments tested in this trial
Adapted Patient Priorities Care (PPC) approach
BehavioralStep 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.
Usual Care
Other interventionUsual care for breast cancer survivorship includes regular visits with the oncology provider and yearly mammograms for surveillance.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
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).
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.
Sponsors and contacts
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The University of Texas Health Science Center, Houston
Lead sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator
National Institute on Aging (NIA)
Collaborator