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Trial Title:
Patient Priorities for Survivorship Care in Older Breast Cancer Survivors
NCT ID:
NCT06478589
Condition:
Breast Cancer Survivorship
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Patient priorities
Survivorship Care
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Adapted Patient Priorities Care (PPC) approach
Description:
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.
Arm group label:
Adapted Patient Priorities Care (PPC) approach plus Usual Care
Intervention type:
Other
Intervention name:
Usual Care
Description:
Usual care for breast cancer survivorship includes regular visits with the oncology
provider and yearly mammograms for surveillance.
Arm group label:
Adapted Patient Priorities Care (PPC) approach plus Usual Care
Arm group label:
Usual Care
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- currently on active cancer therapy (including first or second-line treatment
chemotherapy, radiation and/or surgery, or multimodal treatment)
Gender:
Female
Minimum age:
65 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The University of Texas Health Science Center at Houston
Address:
City:
Houston
Zip:
77006
Country:
United States
Contact:
Last name:
Dana E. Giza, MD
Phone:
713-500-6087
Email:
Dana.E.Giza@uth.tmc.edu
Start date:
October 1, 2024
Completion date:
June 1, 2027
Lead sponsor:
Agency:
The University of Texas Health Science Center, Houston
Agency class:
Other
Collaborator:
Agency:
National Center for Advancing Translational Sciences (NCATS)
Agency class:
NIH
Source:
The University of Texas Health Science Center, Houston
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06478589
