Common Multidimensional Assessment for Multidisciplinary Decision-Making in Oncology: Protocol for a Single-Centre Randomised Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of Participants With a Clinically Meaningful Change in the Treatment Plan
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control (Standard Multidisciplinary Assessment)
Standard Multidisciplinary Assessment
干预措施: Standard Multidisciplinary Assessment (Other)
Intervention:
CMAT-Supported Multidisciplinary Assessment
干预措施: CMAT-Supported Multidisciplinary Assessment Pathway (Other)
结局指标
主要结局
Proportion of Participants With a Clinically Meaningful Change in the Treatment Plan
时间窗: 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.
次要结局
- 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)
- Inter-professional Agreement in CMAT Domain Ratings(During the pre-treatment multidisciplinary assessment, before the final treatment plan is documented)
- Proportion of Triggered Multidisciplinary Discussions Completed(From completion of CMAT assessments to documentation of the final treatment plan, before systemic anticancer treatment begins)
- Proportion of Participants With Grade 3 or Higher 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)
- Proportion of Participants With an Unplanned Emergency Department Visit(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)
- Proportion of Participants With an Unplanned Hospital Admission(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)
研究者
Ozgur Tanriverdi
Prof. Dr. Dr.
Muğla Sıtkı Koçman University