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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07671937
Status
Not Yet Recruiting

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Conditions

  • Breast Cancer
  • Corpus Uteri Cancer
  • Other Female Genital Malignant Neoplasms
  • Ovary Cancer
  • Pancreas Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2030
Completion
Jul 31, 2031

Study Design

Enrollment
2,748 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Group A- Enhanced Usual Care
    Patient-reported outcomes captured; no data presented in any multidisciplinary tumor board. This group is a historical control.
  • Active Comparator: Group B- Enhanced Clinician Awareness
    Patient-reported outcomes (PROs) captured with no personal data presented to multidisciplinary tumor board; other patient's PROs may be presented. This groups is a contemporary control.
  • Experimental: Group C- INSPIRE intervention
    Patient-reported outcomes presented to multidisciplinary tumor board

Primary Outcome Measure

Treatment modifications [ Time Frame: Tumor board presentation to 3 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Gabrielle OAA Rocque, MD
[email protected]
(205) 975-2914
Margaret A Thomas, MPH
[email protected]
2058421632
Gabrielle B Rocque, MD (PRINCIPAL_INVESTIGATOR)
Courtney Williams, DrPH (SUB_INVESTIGATOR)
Nicole Henderson, PhD (SUB_INVESTIGATOR)
Andres Azuero, PhD (SUB_INVESTIGATOR)
Rebecca Arend, MD (SUB_INVESTIGATOR)
Teresa Boitano, MD (SUB_INVESTIGATOR)
Qasim Hussaini, MD (SUB_INVESTIGATOR)
Bart Rose, MD (SUB_INVESTIGATOR)
Joud El Dick, MD (SUB_INVESTIGATOR)
University of California Los Angeles (UCLA)Los AngelesCalifornia90404
Mina Sedrak, MD, MS
Emily Martin, MD (SUB_INVESTIGATOR)
Mina Sedrak, MD (PRINCIPAL_INVESTIGATOR)
University of Oklahoma (OU) Health CampusOklahoma CityOklahoma73126-0901
Ryan Nipp, MD
Ryan Nipp, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

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