- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07645716
Evaluation of Interactions and Group Processes in Multidisciplinary Tumor Boards in Gynecologic Oncology (GOLD)
Group Dynamics Evaluation in ginecOlogic muLtidisciplinary Tumor boarDs
Study Title Group Dynamics Evaluation in Gynecologic Multidisciplinary Tumor Boards - GOLD Study
Background and Rationale Multidisciplinary Tumor Boards are central to complex oncologic decision-making. In gynecologic oncology, clinical decisions often require the integration of knowledge from different specialties, including surgery, medical oncology, radiology, pathology, radiation oncology, and other relevant disciplines. These teams function not only as groups of specialists but also as collective decision-making systems, where communication, collaboration, information sharing, psychological safety, and group dynamics may influence the quality of clinical discussion and final recommendations.
Study Objective The GOLD Study aims to investigate the decision-making process and group dynamics within ovarian and uterine cancer Multidisciplinary Tumor Boards. The study will assess how communication patterns, collaboration, minority dissent, team cohesion, team learning, task interdependence, collective information processing, individual information processing, and psychological safety contribute to Tumor Board performance.
Study Design This is a single-center, prospective, longitudinal observational study involving physicians participating in ovarian and uterine cancer Multidisciplinary Tumor Boards, either in person or online.
Methods At the end of each Tumor Board meeting, participating physicians will complete an online survey using Microsoft Forms. The questionnaire was developed within a scientific collaboration with the Department of Business and Management of LUISS Guido Carli University and includes validated measurement scales derived from the literature. In addition, data on team composition and participation will be collected for each meeting.
Statistical Analysis Survey data and participation data will be analyzed using descriptive statistics, inferential methods, and social network analysis. Network measures such as density and centralization indices will be used to evaluate the structure of interactions and participation over time. Statistical analyses will be performed using Stata, R, and UCINET where appropriate.
Target Population and Sample Size The target population includes physicians involved in the clinical decision-making process during ovarian and uterine cancer Tumor Boards. A total of approximately 400 questionnaires is planned, based on the rule of thumb of at least 10 respondents per questionnaire variable.
Study Duration The expected study duration is six months.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Title Group Dynamics Evaluation in Gynecologic Multidisciplinary Tumor Boards - GOLD Study
Sponsor The study is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Background and Rationale Teams are commonly defined as stable or dynamic groups of individuals who may participate either temporarily or permanently and who share responsibility for achieving a final outcome. In complex organizational and clinical settings, teams are increasingly regarded as systems capable of developing collective intelligence. This collective intelligence reflects the ability of a group to process information, adapt to changing conditions, and operate effectively in environments characterized by complexity, uncertainty, and high information density.
In oncology, decision-making is often too complex to be managed by a single professional perspective. For this reason, Multidisciplinary Tumor Boards have become an essential model for clinical decision-making. These boards bring together specialists from different departments and disciplines, each contributing distinct knowledge, expertise, clinical experience, and interpretative frameworks.
Gynecologic oncology Tumor Boards, particularly those focused on ovarian and uterine cancers, represent a relevant setting in which to study the role of group dynamics. The quality of discussion, the integration of available information, the degree of participation among members, and the way disagreement is expressed and managed may all affect the final clinical recommendation.
The GOLD Study is designed to explore organizational factors and group dynamics within ovarian and uterine cancer Multidisciplinary Tumor Boards. Specifically, it will evaluate how communication, collaboration, decision-making processes, and interaction patterns contribute to team performance.
Primary Objective The primary objective is to investigate in depth the decision-making process and group dynamics of ovarian and uterine cancer Multidisciplinary Tumor Boards and to understand how these dynamics influence the discussion of each clinical case and the final clinical decision.
Secondary Objective The secondary objective is to evaluate the impact of group dynamics on Tumor Board performance using social network analysis. This approach allows the study of interactions among participants, the structure of communication, and the degree of joint participation in meetings over time.
Primary Endpoint The primary endpoint will be assessed through an online survey administered at the end of each ovarian and uterine cancer Tumor Board meeting. The survey will be completed by participating members involved in the clinical decision-making process, including both in-person and online participants. The aim is to capture individual and collective perceptions of the decision-making process and group dynamics after each meeting.
Secondary Endpoint The secondary endpoint will be assessed using social network analysis, including measures such as network density and centralization indices. These measures will allow the study team to map participation, interaction structures, and group decision-making characteristics across repeated Tumor Board meetings.
Study Design This is a single-center, prospective, longitudinal observational study. The object of investigation is not the individual patient but the functioning of the ovarian and uterine cancer Multidisciplinary Tumor Board teams. The study will observe team processes over time without assigning interventions or modifying clinical care pathways.
Target Population The target population includes physicians participating in ovarian and uterine cancer Multidisciplinary Tumor Boards during the study period, either in person or online. Eligible participants must be involved in the clinical decision-making process and represent relevant specialties or roles within the Tumor Board.
Inclusion Criteria Participants will be eligible if they are involved in the clinical decision-making process within ovarian and uterine cancer Multidisciplinary Tumor Boards, participate in the full Tumor Board session, attend either in person or online, and represent at least one relevant specialty or role within the decision-making process.
Exclusion Criteria Participants will be excluded if they attend only part of the Tumor Board session, are trainees or other attendees not directly involved in clinical decision-making, provide only occasional specialty consultation for less than 50% of the study period, submit incomplete surveys, or represent a duplicate specialty or role where another participant with the same role has contributed more consistently to the decision-making process.
Study Procedures At the end of each ovarian and uterine cancer Tumor Board meeting, an online survey will be administered using Microsoft Forms. The survey was developed as part of a scientific collaboration with the Department of Business and Management of LUISS Guido Carli University.
The questionnaire was designed to measure key constructs related to decision-making and team dynamics. These constructs were selected from the scientific literature following an in-depth review and include team cohesion, minority dissent, team learning, task interdependence, collective information processing, team communication, individual information processing, and team psychological safety.
In addition to survey responses, data will be collected on Tumor Board participation and team composition for each meeting. These data will make it possible to examine how different professional roles participate in the discussion and how interaction patterns evolve over time.
Variables and Constructs Assessed
The study will assess several dimensions of group functioning within the Tumor Board setting. These include:
Team cohesion: the extent to which members perceive themselves as part of an integrated and collaborative team.
Minority dissent: the degree to which alternative or dissenting opinions are expressed and considered during the discussion.
Team learning: the ability of the group to reflect, adapt, and improve its decision-making process over time.
Task interdependence: the extent to which participants depend on one another's expertise to reach a clinical recommendation.
Collective information processing: the ability of the team to integrate information from different specialties and sources.
Team communication: the quality, clarity, and effectiveness of exchanges among Tumor Board members.
Individual information processing: the way each participant evaluates and contributes relevant clinical information.
Psychological safety: the extent to which participants feel able to speak openly, raise concerns, and contribute without fear of negative consequences.
Statistical Analysis The analysis will include descriptive statistics, inferential statistics, and social network analysis.
Descriptive statistics will be used to summarize the survey responses. Categorical variables will be reported as absolute frequencies and percentages. Continuous variables and questionnaire scale scores will be reported as means and standard deviations when normally distributed, or as medians and quartiles when the assumption of normality is not met.
Social network analysis will be used to evaluate relationships and interaction patterns among Tumor Board participants. Network density and centralization indices will be calculated to assess how participation and communication are distributed across team members. This approach will help identify whether decision-making is broadly distributed or concentrated around specific roles or individuals.
Inferential analyses, including multiple regression models where appropriate, will be used to evaluate associations between group dynamics, team composition, participation patterns, and Tumor Board performance-related outcomes.
Statistical analyses will be conducted using Stata version 19 and R. UCINET or R may be used for social network analysis.
Sample Size As this is a novel study design and no directly comparable studies are available in the literature, a formal sample size calculation based on previous effect estimates is not feasible. The planned sample size is based on the rule of thumb requiring at least 10 respondents per questionnaire variable. Given that the questionnaire includes 40 items, the study aims to collect approximately 400 questionnaires.
Study Duration The planned duration of the study is six months.
Expected Relevance The GOLD Study may provide insight into how multidisciplinary clinical teams function during gynecologic oncology decision-making. By combining survey-based assessment with social network analysis, the study may help clarify how communication, participation, psychological safety, dissent, and information sharing contribute to the quality of Tumor Board performance. These findings may support future strategies to improve multidisciplinary decision-making in oncology.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Carmine Conte, Dr.
- Phone Number: +393290275147
- Email: armine.conte@policlinicogemelli.it
Study Contact Backup
- Name: Andrea Rosati, Dr.
- Phone Number: +393385054943
- Email: andrea.rosati@policlinicogemelli.it
Study Locations
-
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Roma
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Roma, Roma, Italy, 00168
- Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ginecologia Oncologica
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Sub-Investigator:
- Francesco Fanfani, Prof
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Contact:
- Andrea Rosati, Dr.
- Phone Number: +393385054943
- Email: andrea.rosati@policlinicogemelli.it
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Contact:
- Carmine Conte, Dr
- Phone Number: +393290275147
- Email: carmine.conte@policlinicogemelli.it
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Principal Investigator:
- Anna Fagotti, Prof.
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Sub-Investigator:
- Carmine Conte, Dr.
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Sub-Investigator:
- Andrea Rosati, Dr.
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Sub-Investigator:
- Chiara Cantarini, Dr.
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Sub-Investigator:
- Massimo Criscione, Dr.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Physicians participating in the clinical decision-making process within ovarian and uterine cancer multidisciplinary tumor board meetings.
- Participation in the full tumor board session.
- Participation either in person or online.
- Representation of at least one relevant specialty or role involved in the clinical decision-making process.
Exclusion Criteria:
- Partial attendance at the ovarian and uterine cancer multidisciplinary tumor board session.
- Trainees or other attendees not directly involved in the clinical decision-making process.
- Physicians whose specialty contribution consists of occasional consultation for less than 50% of the study period.
- Incomplete survey completion.
- If more than one member represents the same specialty or role, participants with lower participation in the clinical decision-making process may be excluded.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group/Cohort Label: Gynecologic Multidisciplinary Tumor Board Physicians
Physicians involved in clinical decision-making during ovarian and uterine cancer multidisciplinary tumor board meetings.
Participants complete an online survey after each meeting; no intervention is administered.
|
Participants will complete an online survey after each ovarian and uterine cancer multidisciplinary tumor board meeting.
The survey assesses group dynamics and decision-making processes, including team cohesion, minority dissent, team learning, task interdependence, collective information processing, team communication, individual information processing, and psychological safety.
No clinical, pharmacological, diagnostic, surgical, radiation, behavioral, or therapeutic intervention will be administered.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Decision-Making and Group Dynamics in Gynecologic Tumor Boards
Time Frame: 6-month study period
|
Assessment of the decision-making process and group dynamics within ovarian and uterine cancer multidisciplinary tumor board meetings.
The outcome will be measured using an online survey completed by participating physicians at the end of each meeting.
The survey evaluates team cohesion, minority dissent, team learning, task interdependence, collective information processing, team communication, individual information processing, and team psychological safety.
|
6-month study period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tumor Board Interaction Patterns by Social Network Analysis
Time Frame: Over 6 months
|
Evaluation of participation and interaction patterns among ovarian and uterine cancer multidisciplinary tumor board members using social network analysis, including density and centralization indices.
|
Over 6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Anna Fagotti, Fondazione Policlinico Universitario Agostino Gemelli Irccs
Publications and helpful links
General Publications
- Campion, M. A., Medsker, G. J., & Higgs, A. C. (1993). Relations between work group characteristics and effectiveness: Implications for designing effective work groups. Personnel psychology, 46(4), 823-847.
- Mayo, A. T., Woolley, A. W., John, L., March, C., Witchel, S., & Nowalk, A. (2025). Coordination in dynamic teams: Investigating a learning-productivity trade-off. Organization Science, 36(2), 967-992.
- Markulis, P., Jassawalla, A. R., & Sashittal, H. (2006). The impact of leadership modes on team dynamics and performance in undergraduate management classes. Journal of Education for Business, 81(3), 145-150.
- Liberati EG, Gorli M, Scaratti G. Invisible walls within multidisciplinary teams: Disciplinary boundaries and their effects on integrated care. Soc Sci Med. 2016 Feb;150:31-9. doi: 10.1016/j.socscimed.2015.12.002. Epub 2015 Dec 9.
- Kearney E, Gebert D. Managing diversity and enhancing team outcomes: the promise of transformational leadership. J Appl Psychol. 2009 Jan;94(1):77-89. doi: 10.1037/a0013077.
- Hoegl M, Gemuenden HG (2001) Teamwork quality and the success of innovative projects: A theoretical concept and empirical evidence. Organ. Sci. 12(4):435-449.
- Hackman, J. R. (1987). The design of work teams. In J. Lorsch (Ed.), Handbook of Organizational Behavior. (pp. 315-342). Englewood Cliffs, NJ: Prentice Hill
- Edmondson, A. C., & Harvey, J. F. (2025). Team Learning in the Field: An Organizing Framework and Avenues for Future Research. Small Group Research, 10464964251316877.
- Edmondson, A. (1999). Psychological safety and learning behavior in work teams. Administrative science quarterly, 44(2), 350-383.
- De Dreu CK, West MA. Minority dissent and team innovation: the importance of participation in decision making. J Appl Psychol. 2001 Dec;86(6):1191-201. doi: 10.1037/0021-9010.86.6.1191.
- Carson, J. B., Tesluk, P. E., & Marrone, J. A. (2007). Shared leadership in teams: An investigation of antecedent conditions and performance. Academy of management Journal, 50(5), 1217-1234.
- Carless, S. A., & De Paola, C. (2000). The measurement of cohesion in work teams. Small group research, 31(1), 71-88.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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
- Uterine Diseases
- Genital Diseases, Female
- Endocrine Gland Neoplasms
- Ovarian Diseases
- Adnexal Diseases
- Genital Neoplasms, Female
- Gonadal Disorders
- Ovarian Neoplasms
- Uterine Neoplasms
Other Study ID Numbers
- 27221-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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