An interventional study of T-PAT and Surveys in Advanced Breast Cancer, Stage 4 Breast Cancer and Recurrent Breast Cancer, sponsored by Case Comprehensive Cancer Center. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-26.
Sponsored by Case Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care
This research study will examine how patients with advanced breast cancer and their oncology team communicate and plan ongoing care.The purpose of this study is to find out more about care planning during advanced breast cancer. The study will see if certain aspects of communication make a difference in how patients understand their illness.
The new communication practice (T-PAT) is a team approach for discussing prognosis and treatment goals. T-PAT is specifically designed to a) increase understanding of the prognosis and treatment goal, b) decrease illness uncertainty, and c) help the patient preserve hope for the future.This dedicated clinical visit features a structured discussion of prognosis, treatment goals and options, and end of life concerns. The planned team discussion will include information contributions for the treating medical oncologist, an oncology nurse and social worker who currently work together to provide breast cancer care.
Primary Objectives:
Compare the effects of T-PAT vs. usual care on pertinent patient reported outcomes including: a) understanding of the prognosis and treatment goal, b) illness uncertainty, and c) hope.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 29 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Case Comprehensive Cancer Center is the lead sponsor of 484 studies on the registry; 59 are open to participants now.
Of its 74 completed or terminated interventional studies of FDA-regulated products, 45 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Prognosis discussion intervention with study team.
Other: T-PAT · Other: Surveys
Usual care appointment
Other: Surveys
Pre-test and posttest surveys and questionnaires
Also known as: State Hope Scale, Tolerate Adverse States Survey, Physical Functioning Measure (MOS-PF), Beleif in CUrability (BIC), Illness Uncertainty Survey, Treatment Goal Preference Questionnaire
Feasibility of Implementing the T-PAT Prognosis Discussion Intervention
Accuracy and completion rate of the planned intervention components will be observed.
Time frame: 8 months
Patient Recorded Measures: Hope
Using the Snyder et al.'s State Hope Scale
Time frame: 8 months
Patient Recorded Measures: Willingness to Tolerate Adverse States
Six-Item scale that measures motivation to endure burden associated with aggressive care. Higher scores indicate a greater willingness to tolerate adverse states.
Time frame: 8 months
Patient Recorded Measures: Medical Outcomes Study-Physical Functioning Measure (MOS-PF)
Assess patient physical function
Time frame: 8 months
Patient Recorded Measures: Belief in Curability (BIC)
Assess patients perceptions about prognosis independent of what they recall being told by their doctor.
Time frame: 8 months
Patient Recorded Measures: Illness Uncertainty
16-item scale tapping patient uncertainty about symptoms, diagnosis, treatment, and future plans.
Time frame: 8 months
Patient Recorded Measures: Treatment Goal Preference
Patients will be asked to report their preference for aggressive care.
Time frame: 8 months
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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