Multidisciplinary Decision-Making in Oncology
ConditionSolid Tumor Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMuğla Sıtkı Koçman University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
CMAT-Supported Multidisciplinary Assessment Pathway
Other interventionThe 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
Standard Multidisciplinary Assessment
Other interventionParticipants 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Control (Standard Multidisciplinary Assessment)Active comparator 1 intervention
Group B: Intervention:Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of Participants With a Clinically Meaningful Change in the Treatment Plan
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.
Time frame
From baseline assessment to final treatment plan, before the first administration of systemic anticancer treatmentSecondary outcomes
1
CMAT Completion Rate
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.
Time frame
From randomization to completion of the pre-treatment multidisciplinary assessment, before the first administration of systemic anticancer treatment2
CMAT Completion Time
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.
Time frame
During the pre-treatment multidisciplinary assessment, before the first administration of systemic anticancer treatment3
Proportion of Multidisciplinary Assessments Completed Within the Planned Timeframe
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.
Time frame
From randomization to the first administration of systemic anticancer treatment, with assessments planned within 3 working days where possible4
Participant Acceptability of the Assessment Process
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.
Time frame
Day 0, immediately after the pre-treatment multidisciplinary assessment and before the first treatment doseSponsors and contacts
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Source ClinicalTrials.gov
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