Clinical trial · Interventional
Common Multidimensional Assessment Tool Pilot Study (CMAT Protocol)
Common Multidimensional Assessment for Multidisciplinary Decision-Making in Oncology: Protocol for a Single-Centre Randomised Pilot Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CMAT-Supported Multidisciplinary Assessment Pathway | Other | — | UNRESOLVED |
| Standard Multidisciplinary Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control (Standard Multidisciplinary Assessment)
- description
- Standard Multidisciplinary Assessment
- interventionNames
- Other: Standard Multidisciplinary Assessment
- type
- EXPERIMENTAL
- label
- Intervention:
- description
- CMAT-Supported Multidisciplinary Assessment
- interventionNames
- Other: CMAT-Supported Multidisciplinary Assessment Pathway
Primary outcomes (1)
- measure
- Proportion of Participants With a Clinically Meaningful Change in the Treatment Plan
- timeFrame
- From baseline assessment to final treatment plan, before the first administration of systemic anticancer treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available