INSPIRE: Putting patient-reported info into multidisciplinary tumor boards

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-methods study includes patients and clinicians to see how much MDTB discussions change when patient-reported outcomes are included. It starts with an observational phase and then a randomized trial of the INSPIRE intervention, which captures ePROs and presents them during MDTB deliberations. Clinicians’ experiences are explored through audio recordings and optional interviews to assess feasibility, usefulness, and workflow impacts. Patients complete baseline, 3-month, and 6-month PRO questionnaires in preferred formats, with some data already collected through standard care. The study aims to relate baseline patient fitness to initial treatment recommendations and to evaluate effects on treatment choices, healthcare utilization, and patient-reported outcomes.

Why it matters

Who can join: the full rules

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. This may include diagnosis of a new recurrence. Patients may have had some treatment prior to being seen at a participating institution as long as they are within the 8-week timeframe. Patients may be diagnosed at a participating institution or outside. If there is diagnostic uncertainty and/or patient has not received treatment they will be allowed to participate if they are beyond the 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.

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• University of California Los Angeles (UCLA)
  Los Angeles, California, United States Not yet recruiting
• University of Oklahoma (OU) Health Campus
  Oklahoma City, Oklahoma, United States Not yet recruiting

Study contacts

• Principal investigator: Gabrielle B Rocque, MD — The University of Alabama at Birmingham
• Study coordinator: Gabrielle B Rocque, MD
• Email: grocque@uabmc.edu
• Phone: (205) 975-2914

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.