Recruiting

INSPIRE Intervention

Sponsor:

University of Alabama at Birmingham

Code:

NCT07671937

Conditions

Breast Cancer

Corpus Uteri Cancer

Ovary Cancer

Pancreas Cancer

Other Female Genital Malignant Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

INSPIRE (INtegrating Systematic PatIent-Reported Evaluations)

Capture of patient-reported outcomes

Enhanced Clinician Awareness

Study Details

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.

Conditions

Breast Cancer

Corpus Uteri Cancer

Ovary Cancer

Pancreas Cancer

Other Female Genital Malignant Neoplasms

Study ID

NCT07671937

Start date

Oct 2, 2026

Status verified date

Oct, 2026

Completion date

Jul, 2031

Anticipated

Primary completion date

Jul, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion/Exclusion Criteria: We will include two populations: (1) patients and (2) clinical team members involved in the MDTB.

Inclusion Criteria:

  • Inclusions Criteria- Patients:

1. aged 18 years or older;
2. with suspected or confirmed diagnosis of pancreatic, breast, and gynecologic cancer (all stages) within 8 weeks of diagnosis;
3. intention to be treated at a participating institution;
4. with verbal fluency in English or Spanish; and
5. scheduled to be discussed at MDTB.
  • Inclusion criteria - Clinicians:

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.

Exclusion Criteria:

  • Exclusion criteria - Patients:

Individuals with plans to receive cancer treatment outside the participating institution and inability to speak English or Spanish.

  • Exclusion criteria - Clinician:

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.

Study Design

Enrollment

2748 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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

Interventions

INSPIRE (INtegrating Systematic PatIent-Reported Evaluations)

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

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

Enhanced Clinician Awareness

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Principal Investigator:

Gabrielle B Rocque, MD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Oct 7, 2026

Last verified

Oct, 2026

Keywords

  • PROs
  • Multidiscipinary tumor board
  • INSPIRE intervention
  • Pancreatic Cancer
  • Breast Cancer
  • gynecologic cancers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-10-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.