A Comprehensive Education and Navigational Support Program for Advanced Bladder Cancer
Summary
This clinical trial evaluates the impact of an education and navigation support tool (ENST) on patient and caregiver participation in care coordination for bladder cancer that has spread to nearby tissue or lymph nodes (locally advanced), to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Patients with advanced bladder cancer tend to be older, have multiple medical conditions and often have poor access to health care. An ENST may be an effective method to improve participation in treatment decision-making and care planning among patients with locally advanced, metastatic and unresectable bladder cancer and their caregivers.
Detailed description
PRIMARY OBJECTIVES: I. To assess project readiness and barriers and requirements to assure success we will evaluate organizational readiness and implementation climate through stakeholder engagement. II. Development of an ENST to meet the needs of patients and caregivers, the delivery of which is deemed feasible based on such pre-implementation assessment. III. Implementation and delivery of the proposed ENST. IV. Facilitation of enhanced care coordination for patients with advanced bladder cancer who often have complex medical needs, using measures elaborated in the design and methods section. V. Determining the impact of such interventions, in a quantifiable manner, using validated instruments to assess perceptions of care coordination and self-efficacy, as well as monitoring concordance with guideline-recommended care by leveraging data from a network-wide decision support tool that captures systemic therapy selections. OUTLINE: Patients and caregivers receive access to the bladder cancer ENST and patients undergo psychological distress and nutrition screenings and may attend social work, psychology, and/or nutrition consultations as appropriate throughout the study. Patients, caregivers, and providers also attend virtual support group meetings periodically on study.
Arms & interventions
- ProcedureAssessment of Distress
Undergo psychological distress screening
- OtherConsultation Visit
Attend consultations
- OtherNutritional Assessment
Undergo malnutrition screening
- OtherQuestionnaire Administration
Ancillary studies
- OtherSupportive Care
Receive access to bladder cancer ENST
- OtherSupportive Care
Attend virtual support group meetings
Outcome measures
Primary
Organizational readiness for implementing change (ORIC)
A 12 item instrument used to determine how well employees feel they can implement the change in process .. Each item includes a scale from 1 (Disagree ) to 5 (Agree)
Time frame: At baseline and at 6 months post-implementation
Guideline-concordant care at the institutional level
Guideline-concordant care at the institutional level will be calculated as the percentage of all systemic treatment decisions captured in the Clinical Oncology Pathway.
Time frame: At baseline and at 6 months intervals for the study duration
Patient perception of care coordination
Patient perception of care coordination will be measured using Care Coordination Instrument.
Time frame: At baseline and at 3 and 6 months post-implementation
Patient perception of self-efficacy
Patient perception of self-efficacy will be measured using Generalized Self-Efficacy scale. A 10 item psychometric scale with 4 choice responses ranging from 1 (not at all true) to 4 (Exactly true).
Time frame: At baseline and at 3 and 6 months post-implementation
Caregiver perception of care coordination
Caregiver perception of care coordination will be measured using Care Coordination Instrument for Caregivers.
Time frame: At baseline and at 3 and 6 months post-implementation
Eligibility criteria
Study locations (1)
Roswell Park Cancer Institute
Buffalo, New York, 14263