Access to Fast Transvaginal Ultrasound Through General Practice for Earlier Diagnosis of Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 490
- 试验地点
- 2
- 主要终点
- Indication for fast TVU
研究概览
简要总结
Background
Ovarian cancer (OC) is a disease with a poor prognosis due to diagnosis at late stage. Early-stage OC presents with non-specific and vague symptoms and therefore OC usually is not detected until reaching an advanced stage. From 2008, Danish general practitioners (GPs) could urgently refer patients suspected of having OC to standardized cancer patient pathways (CPPs). The CPP is designed for women presenting specific signs and alarm symptoms, and is supposed to shorten the pathway from suspicion to treatment.
Hypothesis
Direct access to fast transvaginal ultrasound (TVU) through general practice is feasible in earlier diagnosis of OC.
Aim
The aim of this study is to assess the implementation and clinical implications of direct referral access to fast TVU through general practice.
Materials and methods
The study is a feasibility study and GPs from in Central Denmark Region are offered direct access to fast TVU for women aged 40 years or more who present symptoms that could origin from OC, but which are not classified as alarm symptoms. The GPs will receive education about updated knowledge on OC symptoms and the use of the guideline for earlier diagnosis of OC in general practice. The study period is 1 year.
Perspectives
There is a great need to test rational strategies for diagnosing OC at an earlier stage in order to improve survival. For women who do not fulfil access criteria for the CPP, and for whom the main prospect for earlier diagnosis is improved identification of symptomatic OC, this study may provide important new knowledge of how to facilitate the diagnostics of OC in the future and reduce time to diagnosis and improve survival.
详细描述
Background
Around 550 ovarian cancers (OCs) are diagnosed yearly in Denmark. Still, OC is the fourth commonest cause of cancer death amongst women in Denmark. Epithelial ovarian cancers (carcinomas) account for more than 90% of all OCs and Denmark has the second highest incidence in the world (15 per 100.000 women) with a life-time risk around 2%. The mean age at diagnosis is 63 years, and 80% are postmenopausal. In Denmark, 74% are diagnosed in FIGO stage III-IV and therefore at the time of diagnosis have regional or metastatic spread. Five-year survival with FIGO stage I is 83%, stage II 62%, stage III 23% and stage IV 11%. Thus, OC is detected at advanced stages with a very poor prognosis.
In 2008, a national fast-track system for cancer patients was established to ensure fast diagnosis and initiation of treatment. The fast-track system or cancer patient pathway (CPP) implies that patients presenting 'alarm' symptoms of e.g. OC will be referred immediately for diagnostic workup; no more than 14 days must pass from referral to initiation of treatment. Only about one quarter of the women with OC are referred primarily through this route. Therefore, additional accelerated routes are needed for the majority of women with OC.
A possibility could be access to fast TVU through general practice for women presenting with vague and non-specific symptoms that may represent underlying OC.
Aim
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •GPs in the Central Denmark Region
- •Women ≥40 years presenting with vague and non-specific symptoms
排除标准
- •Women who fulfil access criteria for OC fast-track referral.
结局指标
主要结局
Indication for fast TVU
时间窗: one year
GPs refer women to TVU electronically. Information about indications for the investigation, is required in the referral. These informations will be used to evaluate the GPs reasons for referring the women to TVU and will be evaluated descriptively.
Action taken on test results
时间窗: one year
After all TVU investigations, a discharge summary will be send electronically to the referring GP. If indicated, instructions for follow-up investigations is stated in the discharge summary. To evaluate if GPs follow these instructions, data on discharge summary recommended follow-up are compared to data on follow-up referrals made by the GPs. This outcome will be evaluated descriptively.
Frequency of TVU use
时间窗: one year
TVU will be requested electronically through an online referral-system used by Danish GPs. This outcome will be evaluated descriptively by illustrating the relation between time and use of TVU.
Patient-reported symptoms before TVU investigation
时间窗: one year
All women who are referred to TVU will receive a questionnaire prior to investigation, regarding experienced symptoms during the past year.
次要结局
- Findings by TVU on women with vague and non-specific symptoms(one year)
- Ovarian Cancer (OC) stage distribution(one year)