Multidisciplinary Decision-Making in Oncology (CMAT Protocol)

October 2, 2026 updated by: Ozgur Tanriverdi, Muğla Sıtkı Koçman University

Common Multidimensional Assessment for Multidisciplinary Decision-Making in Oncology: Protocol for a Single-Centre Randomised Pilot Trial

This pilot randomized study will evaluate whether adding a brief, structured multidimensional risk-recognition tool to standard multidisciplinary assessment can improve treatment planning for adults who are about to start first-line systemic anticancer treatment for a solid tumor.

Before systemic anticancer treatment begins, patients may have medical, symptom-related, nutritional, psychological, social, or functional problems that can affect treatment safety, feasibility, and continuity. In routine multidisciplinary care, these issues are usually assessed by different health care professionals using discipline-specific approaches. However, risks identified in different areas may not always be considered together in a standardized way.

Participants will be randomly assigned to one of two groups. Both groups will receive the institution's standard multidisciplinary pre-treatment assessment and usual clinical care. In the intervention group, health care professionals will additionally complete the Common Multidimensional Assessment Tool (CMAT), which evaluates six areas: oncological/medical feasibility, symptom burden, nutritional risk, psychological risk, social risk, and functional/geriatric risk. Predefined criteria will be used to identify situations that require additional multidisciplinary discussion before the final treatment plan is documented.

The main outcome of the study is whether the final treatment plan differs in a clinically meaningful way from the provisional treatment plan recorded before multidisciplinary assessment. Such changes may include modifications to the anticancer treatment regimen, dose, treatment timing, frequency or route, as well as the addition of supportive, nutritional, psychological, social, or geriatric interventions.

The study will also evaluate whether the CMAT-supported approach is feasible and acceptable in routine clinical practice, how consistently different professionals identify patient risks, and whether the approach is associated with differences in early treatment-related outcomes such as severe toxicity, treatment delays or dose modifications, emergency department visits, hospital admissions, treatment discontinuation, and adherence problems.

Approximately 60 participants will be enrolled, with about 30 participants in each study group. As a pilot study, the trial is intended primarily to assess feasibility, implementation, and preliminary effect estimates to inform the design of a future larger multicenter study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study evaluates an organizational and decision-support approach designed to improve how information from different professional assessments is integrated before systemic anticancer treatment begins. The study does not compare multidisciplinary care with single-discipline care. Instead, it examines whether adding a common multidimensional risk-recognition and response pathway to an existing multidisciplinary assessment process changes how clinically relevant risks are identified, communicated, and incorporated into treatment planning.

In routine care, members of the multidisciplinary team perform assessments within their respective professional scopes. Although these discipline-specific assessments provide detailed information, clinically important relationships between medical, symptom-related, nutritional, psychological, social, and functional factors may not always be recognized or communicated using a common framework. The Common Multidimensional Assessment Tool (CMAT) is intended to provide an additional shared assessment layer while preserving existing discipline-specific evaluations and clinical responsibilities.

In the CMAT-supported pathway, participating professionals first complete their usual discipline-specific assessments. Each professional then independently completes CMAT before viewing the CMAT responses of other professionals. CMAT assesses six domains: oncological/medical feasibility, symptom burden, nutritional risk, psychological risk, social risk, and functional/geriatric risk. Each domain is rated using a common risk scale, with an additional "not determined" option when a clinically defensible judgment cannot be made.

CMAT responses are interpreted using predefined trigger criteria. A multidisciplinary discussion is recommended when any domain is rated as high priority; significant risks are identified in multiple domains; substantial disagreement exists between professionals regarding the same domain; a psychological, nutritional, social, functional, or geriatric problem directly affects treatment feasibility or safety; or any participating professional explicitly recommends team discussion.

When a trigger criterion is met, the relevant findings are reviewed through a brief multidisciplinary discussion. Following review of the available assessments and any indicated discussion, the medical oncologist documents the final treatment and supportive-care plan. Potential responses may include additional supportive care, psychological, nutritional, social-work, or geriatric intervention, or modification of treatment-related decisions when clinically appropriate. The medical oncologist retains responsibility for all clinical treatment decisions.

CMAT is not intended to replace validated discipline-specific instruments, establish diagnoses, or independently determine anticancer treatment. The active intervention is the complete CMAT-supported pathway, consisting of independent assessment using shared terminology, predefined interpretation criteria, trigger-based multidisciplinary discussion, and structured documentation of how the integrated assessment relates to the final treatment plan.

Because this is a pilot trial, particular emphasis will be placed on implementation of the pathway in routine clinical workflow. The study will examine completion and timing of assessments, missing or undetermined responses, adherence to the predefined trigger algorithm, completion of indicated multidisciplinary discussions, agreement and disagreement between professionals, protocol deviations, and possible contamination of the control condition. These findings, together with preliminary estimates of treatment-planning and early clinical outcomes, will be used to refine the intervention and inform the design and implementation of a subsequent multicenter trial.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • Menteşe
      • Muğla, Menteşe, Turkey (Türkiye), 48000
        • Mugla Education and Research Hospital
        • Contact:
        • Principal Investigator:
          • Ozgur Tanriverdi, Prof. Dr. (Medical Oncology)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 years or older
  • Histologically confirmed solid tumor
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Planned initiation of first-line systemic anticancer treatment (intravenous cytotoxic chemotherapy, immunotherapy, targeted therapy, oral anticancer treatment, or a combination)
  • Systemic treatment planned to be administered in the outpatient setting
  • Sufficient cognitive and communicative capacity to provide written informed consent

Exclusion Criteria:

  • Clinical condition requiring urgent initiation of systemic anticancer treatment before the multidisciplinary assessment can be completed
  • Systemic anticancer treatment planned to begin during an inpatient admission
  • Severe cognitive impairment or communication difficulty preventing valid informed consent
  • Estimated life expectancy of less than 3 months, as judged by the treating medical oncologist
  • Second-line or subsequent systemic anticancer treatment
  • Concurrent participation in another interventional study likely to directly affect the outcomes of this study
  • Previous enrollment in this trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control (Standard Multidisciplinary Assessment)

Standard Multidisciplinary Assessment
Other: Standard Multidisciplinary Assessment

Participants receive the institution's standard pre-treatment multidisciplinary assessment. The medical oncologist, psychologist, dietitian, social worker, and, where clinically indicated, geriatrician perform their usual discipline-specific evaluations using routine clinical procedures and instruments. Each professional provides discipline-specific findings for treatment planning. No CMAT form, CMAT score, or CMAT-specific trigger algorithm is used.
Experimental: Intervention:

CMAT-Supported Multidisciplinary Assessment
Other: CMAT-Supported Multidisciplinary Assessment Pathway

The CMAT-supported multidisciplinary assessment pathway is an organizational and decision-support intervention added to standard pre-treatment multidisciplinary assessment.

After completing their usual discipline-specific assessment, participating professionals independently complete the Common Multidimensional Assessment Tool (CMAT) before viewing the responses of other professionals. CMAT evaluates six domains: oncological/medical feasibility, symptom burden, nutritional risk, psychological risk, social risk, and functional/geriatric risk. Each domain is rated using a standardized risk scale from 0 to 3, with an additional "not determined" option when a clinically defensible judgment cannot be made.

Predefined trigger criteria are then applied. A brief multidisciplinary discussion is recommended when there is a high-priority risk in any domain, significant risks in multiple domains, substantial disagreement between professionals within the same domain, a non-oncological problem tha

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of Participants With a Clinically Meaningful Change in the Treatment Plan
Time Frame: From baseline assessment to final treatment plan, before the first administration of systemic anticancer treatment

A clinically meaningful change is defined as at least one prespecified change between the provisional treatment plan recorded before multidisciplinary assessment and the final treatment plan. Qualifying changes include modification of the systemic anticancer treatment regimen, dose, treatment start date, treatment frequency, or route of administration; addition of supportive treatment; initiation of psychological, nutritional, social-work, or geriatric support; or another documented intervention intended to improve treatment safety or feasibility. The outcome will be reported as the proportion of participants with at least one such change.
From baseline assessment to final treatment plan, before the first administration of systemic anticancer treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
CMAT Completion Rate
Time Frame: From randomization to completion of the pre-treatment multidisciplinary assessment, before the first administration of systemic anticancer treatment

Among participants allocated to the intervention arm, the CMAT completion rate will be calculated as the proportion of expected CMAT assessments that are completed by participating professionals. Completion will be evaluated according to the prespecified study procedures and will be used as a measure of the feasibility of implementing the CMAT-supported multidisciplinary assessment pathway in routine clinical practice.
From randomization to completion of the pre-treatment multidisciplinary assessment, before the first administration of systemic anticancer treatment
CMAT Completion Time
Time Frame: During the pre-treatment multidisciplinary assessment, before the first administration of systemic anticancer treatment

Among participants allocated to the intervention arm, the time required by participating professionals to complete CMAT will be recorded. Completion time will be summarized descriptively and used to evaluate the operational burden and feasibility of incorporating CMAT into the routine pre-treatment multidisciplinary assessment workflow.
During the pre-treatment multidisciplinary assessment, before the first administration of systemic anticancer treatment
Proportion of Multidisciplinary Assessments Completed Within the Planned Timeframe
Time Frame: From randomization to the first administration of systemic anticancer treatment, with assessments planned within 3 working days where possible

The proportion of participants whose required multidisciplinary assessments are completed within the protocol-defined timeframe will be calculated. Standard discipline-specific assessments are planned to be completed before the first treatment administration and, where possible, within three working days after randomization. This outcome will assess the feasibility of integrating study procedures into routine clinical workflow without delaying clinically appropriate treatment.
From randomization to the first administration of systemic anticancer treatment, with assessments planned within 3 working days where possible
Participant Acceptability of the Assessment Process
Time Frame: Day 0, immediately after the pre-treatment multidisciplinary assessment and before the first treatment dose

Acceptability of the pre-treatment assessment process to participants will be assessed using a prespecified 6-item questionnaire administered to each participant in both arms immediately after completion of the multidisciplinary assessment and before the first dose of systemic anticancer treatment. Items address completion burden and perceived usefulness of the assessment process, each rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). The outcome is reported as the proportion of participants responding 4 or 5 on each item, summarized separately by study arm.
Day 0, immediately after the pre-treatment multidisciplinary assessment and before the first treatment dose
Healthcare Professional Acceptability of the CMAT-Supported Pathway
Time Frame: Through study completion, an average of 18 months

Acceptability of the CMAT-supported pathway to participating healthcare professionals will be assessed using a prespecified 6-item questionnaire administered once to each participating professional (medical oncologist, oncology nurse, dietitian, social worker, psychiatrist) after the last intervention-arm participant has completed the pre-treatment multidisciplinary assessment. Items address completion burden and perceived usefulness in routine multidisciplinary practice, each rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). The outcome is reported as the proportion of professionals responding 4 or 5 on each item. Mean CMAT completion time in minutes, recorded on the CMAT form for every intervention-arm participant, is reported alongside as a measure of burden.
Through study completion, an average of 18 months
Inter-professional Agreement in CMAT Domain Ratings
Time Frame: During the pre-treatment multidisciplinary assessment, before the final treatment plan is documented

Among participants in the intervention arm, agreement between participating professionals in the identification and grading of risk across the six CMAT domains will be assessed. Agreement will be evaluated separately by domain using an appropriate agreement statistic according to the number of raters and data structure. Weighted kappa may be used for two raters, while a suitable multi-rater statistic will be used when more than two professionals provide ratings.
During the pre-treatment multidisciplinary assessment, before the final treatment plan is documented
Proportion of Triggered Multidisciplinary Discussions Completed
Time Frame: From completion of CMAT assessments to documentation of the final treatment plan, before systemic anticancer treatment begins

Among participants in the intervention arm for whom at least one predefined CMAT trigger criterion indicates the need for multidisciplinary review, the proportion for whom the indicated multidisciplinary discussion is completed will be calculated. Trigger criteria include high-priority risk, significant risk across multiple domains, substantial inter-professional disagreement, a problem directly affecting treatment feasibility or safety, or an explicit recommendation for team discussion.
From completion of CMAT assessments to documentation of the final treatment plan, before systemic anticancer treatment begins
Proportion of Participants With Grade 3 or Higher Treatment-Related Toxicity
Time Frame: From the first administration of systemic anticancer treatment through Day 60 or completion of the first 2 treatment cycles, according to the prespecified follow-up framework

The proportion of participants experiencing at least one grade 3 or higher treatment-related toxicity will be recorded by study arm. Toxicity will be graded according to the applicable version of the Common Terminology Criteria for Adverse Events (CTCAE). This outcome is exploratory in this pilot trial and will provide a preliminary estimate of early clinically significant treatment-related toxicity.
From the first administration of systemic anticancer treatment through Day 60 or completion of the first 2 treatment cycles, according to the prespecified follow-up framework
Proportion of Participants With an Unplanned Emergency Department Visit
Time Frame: From the first administration of systemic anticancer treatment through Day 60 or completion of the first 2 treatment cycles, according to the prespecified follow-up framework

The proportion of participants with at least one unplanned emergency department visit during the early treatment follow-up period will be recorded and described by study arm. This clinical outcome is exploratory in the pilot trial and will be used to obtain a preliminary estimate for planning a future larger study.
From the first administration of systemic anticancer treatment through Day 60 or completion of the first 2 treatment cycles, according to the prespecified follow-up framework
Proportion of Participants With an Unplanned Hospital Admission
Time Frame: From the first administration of systemic anticancer treatment through Day 60 or completion of the first 2 treatment cycles, according to the prespecified follow-up framework

The proportion of participants with at least one unplanned hospital admission during the early treatment follow-up period will be recorded and described by study arm. This clinical outcome is exploratory in the pilot trial and will be used to obtain a preliminary estimate for planning a future larger study.
From the first administration of systemic anticancer treatment through Day 60 or completion of the first 2 treatment cycles, according to the prespecified follow-up framework

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Muğla Sıtkı Koçman University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 5, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 21, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CMAT-RCT-P001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the results reported in the primary study publication may be shared after completion of the study, subject to applicable ethical and institutional approvals, a data-sharing agreement, and a scientifically justified request. No directly identifying participant information will be shared.

IPD Sharing Time Frame

De-identified IPD and supporting information will become available following publication of the primary study results and will remain available for 5 years after publication.

IPD Sharing Access Criteria

Qualified researchers may request access to de-identified individual participant data underlying the results reported in the primary study publication and the specified supporting documents. Requests must include a scientifically justified research proposal and will be reviewed by the study investigators and, where required, the relevant institutional or ethics authorities. Access will be provided only after approval of the request and completion of an appropriate data-sharing agreement. Data may be used only for the approved research purpose and in accordance with applicable data-protection and ethical requirements. No directly identifying participant information will be shared.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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