INtegrating Systematic PatIent-Reported Evaluations in Multi-Disciplinary Tumor Boards: The INSPIRE Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • INSPIRE (INtegrating Systematic PatIent-Reported Evaluations)

    Behavioral

    The 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

    Behavioral

    Capture of patient-reported outcomes including geriatric assessment and patient preferences

  • Enhanced Clinician Awareness

    Behavioral

    Inclusion of patients within tumor board that may have patient-reported outcomes

Treatment groups

2,748 Participants
are divided into 3 treatment groups
Group A: Group A- Enhanced Usual CareActive comparator 1 intervention
Group B: Group B- Enhanced Clinician AwarenessActive comparator 2 interventions
Group C: Group C- INSPIRE interventionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Treatment modifications

Any dose reduction or delay during treatment.

Time frame
Tumor board presentation to 3 months

Secondary outcomes

1

Treatment Modifications (2)

Treatment dose reduction or delay

Time frame
Tumor board presentation to 6 months
2

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

Time frame
Tumor board to 6 months
3

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

Time frame
Tumor board to 3 months
4

Treatment alignment

Concordance between (1) treatment received and GA status.

Time frame
Tumor board presentation to 3 months

Other outcomes

1

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

Time frame
During tumor board discussion
2

Fitness discussed

Proportion of cases in which clinical team specifically discussed fitness within MDTB

Time frame
During tumor board and/or initial clinic note
3

Preferences Discussed

Proportion of cases in which clinical team specifically discussed preferences within tumor board

Time frame
during tumor board and/or initial clinic note
4

Comorbid conditions discussed

Proportion of cases in which clinical team specifically discussed comorbid conditions within MDTB

Time frame
during tumor board and/or initial clinic note

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

University of Oklahoma

Collaborator

University of California, Los Angeles

Collaborator

Canopy Cancer Collective, LLC

Collaborator