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Starting soon Not applicable

Multidisciplinary Decision-Making in Oncology

NCT07838103 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2027-01-10
Last updated
2026-10-06

Condition(s) studied

Solid Tumor Cancer

Investigational drug(s) / intervention(s)

CMAT-Supported Multidisciplinary Assessment PathwayStandard Multidisciplinary Assessment

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

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.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Proportion of Participants With a Clinically Meaningful Change in the Treatment Plan — 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.

Trial sites (1)

FacilityCityRegionStatus
Mugla Education and Research Hospital Muğla Menteşe
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07838103 on ClinicalTrials.gov ↗ ← All trials in Turkey