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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Pancreas Cancer; Ovary Cancer; Corpus Uteri Cancer; Other Female Genital Malignant Neoplasms
• Intervention / Treatment: Behavioral: Capture of patient-reported outcomes; Behavioral: Enhanced Clinician Awareness; Behavioral: INSPIRE (INtegrating Systematic PatIent-Reported Evaluations)

Detailed Description

Study Type/Design This multi-methods study will include two participant groups: patient participants and clinician/provider participants. The patient portion includes an initial prospective observational cohort followed by a randomized controlled trial of the INSPIRE intervention, which involves inclusion of electronic patient-reported outcomes in tumor board discussions. The clinician/provider portion includes audio recording of multidisciplinary tumor board discussions and an optional post-study semi-structured interview with clinicians/providers to understand experiences with the INSPIRE intervention, including feasibility, usefulness, workflow considerations, and implementation challenges.

Patient Participants Patients who agree to participate will complete patient-reported questionnaires at baseline, 3 months, and 6 months. Questionnaires may be completed online by text or email, by phone with responses entered by a research assistant, in person on a tablet, or on paper, based on patient preference. The baseline questionnaire will include questions about health, daily function, quality of life, nutrition, cognition, social support, caregiver support, treatment preferences, and decision-making preferences. At UAB, some of these electronic patient-reported outcomes may already be collected as part of standard clinical care. If a patient has already completed overlapping questionnaires as part of standard care, the patient will not be asked to repeat those questions. Instead, the study team will abstract the relevant information from the electronic medical record or electronic patient-reported outcomes system for research purposes. If the patient has not completed the standard-of-care questionnaires, the patient will complete the study-specific REDCap questionnaire in English or Spanish.

For patients in the initial observational cohort, baseline questionnaire completion may occur within 2 weeks of enrollment. If patients do not complete more than 50% of the questionnaires within 2 weeks, they will be excluded from the study. For patients in the randomized intervention component, completion of the baseline questionnaire will be required before tumor board presentation. The study team will document patients who are unable to complete the questionnaire and the reason. Participants will also complete follow-up questionnaires at approximately 3 months and 6 months after enrollment. These follow-up questionnaires may be completed electronically, by phone, or on paper and will be entered into REDCap. If a patient does not complete a follow-up questionnaire, the research coordinator will make up to three attempts to contact the patient to encourage completion. These contacts may occur by phone, patient portal, or in person during clinic.

The baseline questionnaire is expected to take approximately 40 minutes if the full study questionnaire is completed. If the patient has already completed some electronic patient-reported outcomes as part of standard care, the abbreviated questionnaire is expected to take approximately 20 minutes. The 3-month and 6-month questionnaires are expected to take approximately 10 minutes each. Patients will not be asked to complete any additional clinic visits or study-specific medical procedures.

Use of Patient Questionnaire Information in Tumor Board

After a patient completes the baseline questionnaire, the research coordinator will review the responses and, for patients assigned to the INSPIRE intervention group, create a single PowerPoint slide for tumor board presentation. The slide may include patient frailty or fitness status, frailty components, treatment preferences, decision-making style, and a map showing travel distance from the patient's home to the cancer center. For patients randomized to the intervention group, the slide will be shared during tumor board. The slide will be sent by secure email or secure file transfer to the clinician presenting the case. If the clinician is not available, a research team member or research assistant may present the slide during tumor board. For patients not randomized to the formal INSPIRE presentation group, questionnaire information may still be available to the care team through clinical or study-related workflows, but it will not be formally presented during tumor board as part of the intervention.

Medical Record Review for Patient Participants

Study staff will review patient medical records at baseline to collect information such as demographics, cancer diagnosis and stage, treatment history, prior visits with geriatrics or palliative care, prior cancer history, performance status, medical comorbidities, medications, laboratory results, imaging results, and other information relevant to cancer care. At approximately 6 months, study staff will review the medical record again to collect information about treatment recommendations, treatments received, treatment modifications or delays, complications, health care utilization, palliative care, hospice care, and survival status. Information that cannot be obtained from discrete electronic medical record fields will be entered into REDCap by trained study staff. If a patient withdraws from the study, the study team will ask whether the patient will allow continued medical record review. If the patient declines continued medical record review, the patient's data will be censored at the time of withdrawal.

Tumor Board Recording Procedures

Data from multidisciplinary tumor board presentations on individual patients will be captured by a research coordinator and entered into a REDCap database. This will include HIPPA-protected information, including the MRN. Only the study team will have access to the REDCap database, which will allow them to link individual patient demographics, treatment information, survey responses, and presentation details.

Clinic Notes Review Related to Tumor Board Decision-Making

To understand how treatment decisions are documented after tumor board, the research coordinator will review clinic notes leading up to the initial treatment recommendation. Relevant note content will be copied into a separate document, de-identified, and uploaded for qualitative analysis. The same general coding approach used for tumor board discussions will be applied to clinic note content.

Clinician/Provider Participants

Tumor Board Recording Procedures

Trained research assistants will audio-record eligible tumor board meetings to document discussion content, workflow, and use of patient-reported information in treatment planning. All providers will be informed that tumor board discussions are being recorded for research purposes. If a provider chooses not to participate, that provider's verbal contributions will not be analyzed. Approximately 600 MDTB meetings will be recorded during the study period. These recordings will include eligible tumor board meetings in which enrolled or potentially eligible patient cases are discussed, and we estimate 4-5 patients per tumor board.

All participating tumor boards are expected to occur in hybrid or virtual formats, such as Zoom, Microsoft Teams, or a similar platform. If the tumor board is recorded as part of standard-of-care, the research team will be provided the recording by the clinical team. If the tumor board is not recorded as part of standard of care, the research assistant will attend the meeting and use a recording device to capture the tumor board discussion. The research assistant will also complete standardized data capture forms about the tumor board context and individual patient case presentations, including information such as meeting length, number of cases presented, attendee roles, and discussion flow. The research assistant will not otherwise participate in the clinical discussion, except when presenting the INSPIRE slide if needed.

Field Notes

At each participating site, the research coordinator will capture field notes related to eligible multidisciplinary tumor board meetings. These field notes will document contextual information that may not be fully captured in the audio recording or structured data collection forms, such as meeting format, attendance patterns, workflow issues, timing or agenda changes, interruptions, technical issues, and whether patient-reported information was presented as planned. The research coordinator may also document observations about how the INSPIRE information was incorporated into the tumor board discussion, including who presented the information, whether the information was visible or accessible to tumor board participants, and any notable questions or discussion related to the geriatric assessment, patient preferences, travel distance, or other patient-reported information. Field notes will not be used to evaluate individual clinicians. Field notes will be uploaded into REDCap and stored with other study data.

Clinician Interviews

Clinicians/providers may also be invited to participate in a one-on-one semi-structured interview. The PIs or lead co-investigators will invite clinicians/providers by email. Interviews will be conducted by trained study staff at a time convenient for the participant. Interviews will be conducted remotely using a secure, HIPAA-compliant videoconferencing platform or by telephone, based on participant preference. Interviews are expected to last approximately 30 to 60 minutes. The interviewer will ask about the participant's role in tumor board discussions and experiences with the INSPIRE intervention, including the feasibility and usefulness of incorporating geriatric assessment and patient preference data into tumor board, how the information was presented, factors that supported or limited use of the information in decision-making, provider burden, and recommendations for refinement and future expansion. With participant permission, interviews will be audio-recorded and professionally transcribed or transcribed by study staff for analysis. Clinician/provider participants may decline to participate in an interview, skip any question, or stop the interview at any time. Clinicians/providers who complete an interview will receive $50 for their participation. Payment will be provided after the interview is completed via Greenphire/ClinCard provided in person or via mail at the participants preference.

Site Survey

Annually, site leads for each tumor type will complete a site survey describing basic information about tumor board structure and electronic patient-reported outcome use. This will include information about how tumor boards are organized and how patient-reported information is used in routine care.

• Study Type: Interventional
• Enrollment (Estimated): 2748
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Margaret A Thomas, MPH; Phone Number: 2058421632; Email: margaretathomas@uabmc.edu
• Study Contact Backup: Name: Gabrielle B Rocque, MD; Phone Number: (205) 975-2914; Email: grocque@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
      • Principal Investigator: Gabrielle B Rocque, MD
      • Contact: Margaret A Thomas, MPH; Phone Number: 2058421632; Email: margaretathomas@uabmc.edu
      • Sub-Investigator: Rebecca Arend, MD
      • Contact: Gabrielle OAA Rocque, MD; Phone Number: (205) 975-2914; Email: grocque@uabmc.edu
      • Sub-Investigator: Courtney Williams, DrPH
      • Sub-Investigator: Nicole Henderson, PhD
      • Sub-Investigator: Andres Azuero, PhD
      • Sub-Investigator: Teresa Boitano, MD
      • Sub-Investigator: Qasim Hussaini, MD
      • Sub-Investigator: Bart Rose, MD
      • Sub-Investigator: Joud El Dick, MD
  • California
    • Los Angeles, California, United States, 90404
      • University of California Los Angeles (UCLA)
      • Principal Investigator: Mina Sedrak, MD
      • Contact: Mina Sedrak, MD, MS
      • Sub-Investigator: Emily Martin, MD
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73126-0901
      • University of Oklahoma (OU) Health Campus
      • Principal Investigator: Ryan Nipp, MD
      • Contact: Ryan Nipp, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Capture of patient-reported outcomes; Capture of patient-reported outcomes including geriatric assessment and patient preferences
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.	Behavioral: Capture of patient-reported outcomes; Capture of patient-reported outcomes including geriatric assessment and patient preferences; Behavioral: Enhanced Clinician Awareness; Inclusion of patients within tumor board that may have patient-reported outcomes
Experimental: Group C- INSPIRE intervention; Patient-reported outcomes presented to multidisciplinary tumor board	Behavioral: Capture of patient-reported outcomes; Capture of patient-reported outcomes including geriatric assessment and patient preferences; Behavioral: Enhanced Clinician Awareness; Inclusion of patients within tumor board that may have patient-reported outcomes; Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment modifications	Any dose reduction or delay during treatment.	Tumor board presentation to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Modifications (2)	Treatment dose reduction or delay	Tumor board presentation to 6 months
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	Tumor board to 6 months
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	Tumor board to 3 months
Treatment alignment	Concordance between (1) treatment received and GA status.	Tumor board presentation to 3 months
Treatment Intensity	Relative dose intensity, with doses characterized as full or reduced for initial treatment	Tumor board presentation to 3 months
Surgical Complications	Surgical complications due to cancer surgery using Clavien-Dindo classification for surgical complications	Tumor board presentation to 3 months
Surgical Complications	Surgical complications related to cancer surgery using Clavien-Dindo classification for surgical complications	Tumor board presentation to 6 months
ER visits - Any (1)	Any ER visits	Tumor board presentation to 3 months
ER visits - Any (2)	Any ER visits	Tumor board presentation to 6 months
ER visits - Count (1)	Number of ER visits	Tumor board presentation to 3 months
ER visits - Count (2)	Number of ER visits	Tumor board presentation to 6 months
Hospitalization - Any (1)	Any hospitalization	Tumor board presentation to 3 months
Hospitalization - Any (2)	Any hospitalization during study period	Tumor board presentation to 6 months
Hospitalization - Count (1)	Number of hospitalizations	Tumor board presentation to 3 months
Hospitalizations - Count (2)	Number of hospitalizations in time period	Tumor board presentation to 6 months
ICU - Any (1)	Any ICU admission during time period	Tumor board presentation to 3 months
ICU - Any (2)	Any ICU admission during time period	Tumor board presentation to 6 months
ICU - Count (1)	Number of hospitalization	Tumor board presentation to 3 months
ICU - Count (2)	Number of ICU admissions	Tumor board presentation to 6 months
Perception of Decision-Making Style	Control Preferences Scale; Patient perception that the treatment decision was patient-driven, shared, or provider-driven	3 months from tumor board
Patient Activation (1)	Patient Activation Measure (PAM) scores, which captured patient knowledge, skill, and confidence in self-management	3 months from tumor board
Patient Activation (2)	Patient Activation Measure (PAM) scores that captured patient knowledge, skill, and confidence in self-management	6 months from tumor board
Treatment Satisfaction (1)	Score on Treatment Satisfaction Questionnaire for Medication (TSQM)	3 months from tumor board
Treatment Satisfaction (2)	Questionnaire for Medication (TSQM) score	6 months from tumor board
Decision Regret (1)	Score on Decision Regret Scale	3 months from tumor board
Decision Regret (2)	Score on Decision Regret Scale	6 months from tumor board
Quality of Life (1)	Score on PROMIS-Global scale	3 months from tumor board
Quality of Life (2)	Score on PROMIS-Global scale	6 months from tumor board

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	During tumor board discussion
Fitness discussed	Proportion of cases in which clinical team specifically discussed fitness within MDTB	During tumor board and/or initial clinic note
Preferences Discussed	Proportion of cases in which clinical team specifically discussed preferences within tumor board	during tumor board and/or initial clinic note
Comorbid conditions discussed	Proportion of cases in which clinical team specifically discussed comorbid conditions within MDTB	during tumor board and/or initial clinic note

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: University of California, Los Angeles; University of Oklahoma; Canopy Cancer Collective, LLC
• Investigators: Principal Investigator: Gabrielle B Rocque, MD, The University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2031

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Breast Cancer; Pancreatic Cancer; gynecologic cancers; PROs; Multidiscipinary tumor board; INSPIRE intervention
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Digestive System Neoplasms; Digestive System Diseases; Genital Diseases, Female; Endocrine Gland Neoplasms; Pancreatic Diseases; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Ovarian Neoplasms; Breast Neoplasms; Pancreatic Neoplasms
• Other Study ID Numbers: IRB-300016939

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We would consider data sharing upon reasonable request with appropriate regulatory approvals and support for data abstraction.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No