ISRCTN15497400已完成未知
CANAssess 2: Cancer Patients' Needs Assessment in Primary Care – A Cluster Randomised Controlled Trial
niversity of Hull0 个研究点目标入组 788 人开始时间: 2020年4月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 788
研究概览
简要总结
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35508352/ (added 05/05/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •GENERAL PRACTICES:
- •1. Willing to be trained and to offer and use the NAT-C, if so allocated, for all recruited patients
- •2. Willing to commit to trial procedures:
- •2.1. Supporting screening and inviting patients to participate
- •2.2. Allowing researchers access to the GP surgery to support the study
- •3. Capacity to recruit approximately 20 patients
- •4. Written informed consent provided by practice manager or deputy
- •1. Adults (aged 18 years and above)
- •2. Diagnosis of active cancer (receiving anti-cancer treatment both with curative or palliative intent; managed with watch and wait”; recurrent or metastatic; or inoperable) Note: anti-cancer treatment includes any treatment designed to modify the growth of the cancer, such as chemotherapy, immunotherapy, hormone therapy, radiotherapy, or surgery
- •3. Willing and able to complete questionnaires at the trial follow-up schedule (able to complete trial measures
- •4. Provision of written or observed verbal informed consent.
- •5. Sufficient knowledge of the English language to provide informed consent and complete trial questionnaires. The use of an appropriate translator/interpreter is allowed
- •1. Adults (aged 18 years and above)
- •2. Nominated by the patient
- •3. Able to complete trial measures
- •4. Written or observed verbal informed consent
- •5. Sufficient knowledge of the English language to provide informed consent and complete trial questionnaires. The use of an appropriate translator/interpreter is allowed
- •PROCESS EVALUATION - CLINICIANS:
- •1. Any clinician who has received NAT-C training (survey 1)
- •2. Any clinician who has delivered the NAT-C intervention (survey 2)
- •3. Any clinician who has received NAT-C training and/or delivered the NAT-C intervention (interview)
- •PROCESS EVALUATION - OTHER GP STAFF:
- •1. Practice management and administrative staff in participating intervention practices
- •PROCESS EVALUATION - KEY STAKEHOLDERS:
- •1. Identified by the research team or clinical experts as having a key role in health policy and commissioning, relevant to cancer care in primary care
排除标准
- •Current exclusion criteria as of 01/03/2022:
- •GP surgeries that do not meet the inclusion criteria will be excluded
- •1. In complete remission (no clinical or radiological evidence of cancer, and at least one-month post anti-cancer treatments)
- •2. With basal cell carcinoma only
- •3. Living in a care home or other institutional setting
- •4. Within 1 month of receiving their initial cancer diagnosis
- •1. Employed to look after the patient
- •PROCESS EVALUATION - CLINICIANS:
- •1. Clinicians on the Usual Care arm of the study
- •PROCESS EVALUATION - OTHER GP STAFF:
- •1. Practice management and administrative staff on the Usual Care arm of the study
- •Previous exclusion criteria:
- •GENERAL PRACTICES:
- •1. Locum GPs who work across general practices and registrars due to leave the practice before the end of the trial will be excluded to avoid potential contamination
- •2. GP surgeries with existing or planned (within the recruitment period of the trial) systematic implementation of cancer care review services/holistic needs assessments, which have the potential to significantly overlap with the NAT-C (as determined by the CI & GP hub leads), will be excluded.
- •1. In complete remission (no clinical or radiological evidence of cancer, and at least 1-month post anti-cancer treatments)
- •2. With basal cell carcinoma
- •3. Living in a care home or other institutional setting
- •4. Within 1 month of receiving their initial cancer diagnosis
- •1. Paid carers
- •PROCESS EVALUATION - CLINICIANS:
- •1. Clinicians on the Usual Care arm of the study
- •PROCESS EVALUATION - OTHER GP STAFF:
- •1. Practice management and administrative staff on the Usual Care arm of the study
研究者
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