NCT07671937

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,748

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
58mo left

Started Sep 2026

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Sep 2026Jul 2031

First Submitted

Initial submission to the registry

June 22, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2031

Last Updated

July 2, 2026

Status Verified

June 1, 2026

Enrollment Period

3.8 years

First QC Date

June 22, 2026

Last Update Submit

June 30, 2026

Conditions

Keywords

PROsMultidiscipinary tumor boardINSPIRE interventionPancreatic CancerBreast Cancergynecologic cancers

Outcome Measures

Primary Outcomes (1)

  • Treatment modifications

    Any dose reduction or delay during treatment.

    Tumor board presentation to 3 months

Secondary Outcomes (28)

  • Treatment Modifications (2)

    Tumor board presentation to 6 months

  • Symptom Experience

    Tumor board to 6 months

  • Symptom Experience (1)

    Tumor board to 3 months

  • Treatment alignment

    Tumor board presentation to 3 months

  • Treatment Intensity

    Tumor board presentation to 3 months

  • +23 more secondary outcomes

Other Outcomes (4)

  • Tumor board context

    During tumor board discussion

  • Fitness discussed

    During tumor board and/or initial clinic note

  • Preferences Discussed

    during tumor board and/or initial clinic note

  • +1 more other outcomes

Study Arms (3)

Group A- Enhanced Usual Care

ACTIVE COMPARATOR

Patient-reported outcomes captured; no data presented in any multidisciplinary tumor board. This group is a historical control.

Behavioral: Capture of patient-reported outcomes

Group B- Enhanced Clinician Awareness

ACTIVE COMPARATOR

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.

Behavioral: Capture of patient-reported outcomesBehavioral: Enhanced Clinician Awareness

Group C- INSPIRE intervention

EXPERIMENTAL

Patient-reported outcomes presented to multidisciplinary tumor board

Behavioral: INSPIRE (INtegrating Systematic PatIent-Reported Evaluations)Behavioral: Capture of patient-reported outcomesBehavioral: Enhanced Clinician Awareness

Interventions

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

Group C- INSPIRE intervention

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

Group A- Enhanced Usual CareGroup B- Enhanced Clinician AwarenessGroup C- INSPIRE intervention

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

Group B- Enhanced Clinician AwarenessGroup C- INSPIRE intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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
  • scheduled to be discussed at MDTB.
  • All clinical team members participating in the pancreatic, breast, or gynecologic MDTB at a participating site will be included and have pre-emptively agreed to participation.
  • Individuals with plans to receive cancer treatment outside the participating institution and inability to speak English or Spanish.
  • Clinicians will retain the opportunity to opt-out of participation, in which case their portions of the discussion will not be included in the analysis; however, this is not anticipated based on pilot data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California Los Angeles (UCLA)

Los Angeles, California, 90404, United States

Location

University of Oklahoma (OU) Health Campus

Oklahoma City, Oklahoma, 73126-0901, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsOvarian NeoplasmsPancreatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersDigestive System NeoplasmsDigestive System DiseasesPancreatic Diseases

Study Officials

  • Gabrielle B Rocque, MD

    The University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabrielle B Rocque, MD

CONTACT

Margaret A Thomas, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 22, 2026

First Posted

June 26, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2031

Last Updated

July 2, 2026

Record last verified: 2026-06

Locations