About this trial
The purpose of the study is to characterize baseline multidisciplinary tumor board (MDTB) context and variability, evaluate the relationship between baseline fitness of patients with cancer and initial treatment recommendations, and assess the impact of the INSPIRE intervention, which involves including electronic patient reported outcomes (ePROs) within MDTB on MDTB discussion content, provider burden, treatment recommended and received, healthcare utilization, and patient-reported outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
aged 18 years or older;
with suspected or confirmed diagnosis of pancreatic, breast, and gynecologic cancer (all stages) within 8 weeks of diagnosis;
intention to be treated at a participating institution;
with verbal fluency in English or Spanish; and
Trial design
Parallel
Treatments tested in this trial
INSPIRE (INtegrating Systematic PatIent-Reported Evaluations)
BehavioralThe INSPIRE intervention is the systematic capture and presentation of patient-reported outcomes (geriatric assessment, patient preferences, and distance to care) within multi-disciplinary tumor boards
Capture of patient-reported outcomes
BehavioralCapture of patient-reported outcomes including geriatric assessment and patient preferences
Enhanced Clinician Awareness
BehavioralInclusion of patients within tumor board that may have patient-reported outcomes
Treatment groups
Trial outcomes
Primary outcomes
Treatment modifications
Any dose reduction or delay during treatment.
Secondary outcomes
Treatment Modifications (2)
Treatment dose reduction or delay
Symptom Experience
Composite and Individual component scores on Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) assessment for frequency, severity, and interference of nausea, vomiting, diarrhea, shortness of breath, hair loss, concentration, fatigue, numbness and tingling, pain
Symptom Experience (1)
Composite score and individual components on Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) assessment for frequency, severity, and interference of nausea, vomiting, diarrhea, shortness of breath, hair loss, concentration, fatigue, numbness and tingling, pain
Treatment alignment
Concordance between (1) treatment received and GA status.
Other outcomes
Tumor board context
Average number of participants; average number of cases presented; discipline of team members present; role of person typically presenting cases; length of average case; baseline presentation of frailty, comorbid conditions, preferences
Fitness discussed
Proportion of cases in which clinical team specifically discussed fitness within MDTB
Preferences Discussed
Proportion of cases in which clinical team specifically discussed preferences within tumor board
Comorbid conditions discussed
Proportion of cases in which clinical team specifically discussed comorbid conditions within MDTB
Sponsors and contacts
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University of Alabama at Birmingham
Lead sponsor
University of Oklahoma
Collaborator
University of California, Los Angeles
Collaborator
Canopy Cancer Collective, LLC
Collaborator