Multidisciplinary Decision-Making in Oncology (CMAT Protocol)
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.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
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.
Typ studie
Typ studie
Zápis (Odhadovaný)
Zápis
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
Studijní kontakt
- Jméno: Ozgur Tanriverdi, Prof. Dr. Dr. (PhD, MD)
- Telefonní číslo: 90252 211 5166
- E-mail: dr.ozgur.tanriverdi@gmail.com
Studijní místa
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Menteşe
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Muğla, Menteşe, Turecko (Türkiye), 48000
- Mugla Education and Research Hospital
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Kontakt:
- Ethem Acar, Prof. Dr. (MD)
- Telefonní číslo: +90 252 214 13 23
- E-mail: ethemacar@mu.edu.tr
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Vrchní vyšetřovatel:
- Ozgur Tanriverdi, Prof. Dr. (Medical Oncology)
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
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Aktivní komparátor: Control (Standard Multidisciplinary Assessment)
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. |
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Experimentální: Intervention:
CMAT-Supported Multidisciplinary Assessment |
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 |
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Proportion of Participants With a Clinically Meaningful Change in the Treatment Plan
Časové okno: From baseline assessment to final treatment plan, before the first administration of systemic anticancer treatment
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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
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Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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CMAT Completion Rate
Časové okno: From randomization to completion of the pre-treatment multidisciplinary assessment, before the first administration of systemic anticancer treatment
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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
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CMAT Completion Time
Časové okno: During the pre-treatment multidisciplinary assessment, before the first administration of systemic anticancer treatment
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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
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Proportion of Multidisciplinary Assessments Completed Within the Planned Timeframe
Časové okno: From randomization to the first administration of systemic anticancer treatment, with assessments planned within 3 working days where possible
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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
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Participant Acceptability of the Assessment Process
Časové okno: Day 0, immediately after the pre-treatment multidisciplinary assessment and before the first treatment dose
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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
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Healthcare Professional Acceptability of the CMAT-Supported Pathway
Časové okno: Through study completion, an average of 18 months
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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
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Inter-professional Agreement in CMAT Domain Ratings
Časové okno: During the pre-treatment multidisciplinary assessment, before the final treatment plan is documented
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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
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Proportion of Triggered Multidisciplinary Discussions Completed
Časové okno: From completion of CMAT assessments to documentation of the final treatment plan, before systemic anticancer treatment begins
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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
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Proportion of Participants With Grade 3 or Higher Treatment-Related Toxicity
Časové okno: 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
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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
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Proportion of Participants With an Unplanned Emergency Department Visit
Časové okno: 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
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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
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Proportion of Participants With an Unplanned Hospital Admission
Časové okno: 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
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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
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Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Začátek studia
Primární dokončení (Odhadovaný)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
Další identifikační čísla studie
- CMAT-RCT-P001
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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.
Časový rámec sdílení IPD
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.
Kritéria přístupu pro sdílení IPD
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.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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