Common Multidimensional Assessment Tool Pilot Study (CMAT Protocol)

NCT07838103 | Not Yet Recruiting

• 1 other identifier: CMAT-RCT-P001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumor Cancer

Outcome Measures

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.

  From baseline assessment to final treatment plan, before the first administration of systemic anticancer treatment

Secondary Outcomes (10)

• CMAT Completion Rate

  From randomization to completion of the pre-treatment multidisciplinary assessment, before the first administration of systemic anticancer treatment

• CMAT Completion Time

  During the pre-treatment multidisciplinary assessment, before the first administration of systemic anticancer treatment

• Proportion of Multidisciplinary Assessments Completed Within the Planned Timeframe

  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

  Day 0, immediately after the pre-treatment multidisciplinary assessment and before the first treatment dose

• Healthcare Professional Acceptability of the CMAT-Supported Pathway

  Through study completion, an average of 18 months

Study Arms (2)

Control (Standard Multidisciplinary Assessment)

ACTIVE COMPARATOR

Standard Multidisciplinary Assessment

Other: Standard Multidisciplinary Assessment

Intervention:

EXPERIMENTAL

CMAT-Supported Multidisciplinary Assessment

Other: CMAT-Supported Multidisciplinary Assessment Pathway

Interventions

CMAT-Supported Multidisciplinary Assessment Pathway OTHER

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

Intervention:

Standard Multidisciplinary Assessment OTHER

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.

Control (Standard Multidisciplinary Assessment)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Mugla Education and Research Hospital

Muğla, Menteşe, 48000, Turkey (Türkiye)

Location

Central Study Contacts

Ozgur Tanriverdi, Prof. Dr. Dr. (PhD, MD)

CONTACT

90252 211 5166; dr.ozgur.tanriverdi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and treating multidisciplinary professionals will not be masked to study allocation because of the nature of the intervention. Independent outcome assessors who classify changes between the provisional and final treatment plans will be masked to treatment allocation. Where practicable, assessors of clinical events will also remain masked to allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Dr.

Model Details: Participants are individually randomized in a 1:1 ratio to standard multidisciplinary assessment alone or standard multidisciplinary assessment supplemented by the CMAT-supported pathway.

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 24, 2026
• Study Start (Estimated): January 10, 2027
• Primary Completion (Estimated): April 5, 2028
• Study Completion (Estimated): June 21, 2028
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

TU (1)