跳至主要内容
临床试验/CTRI/2017/08/009358
CTRI/2017/08/009358尚未招募不适用

A prospective observational study to evaluate the value of nurse led telephone based questionnaire in detecting recurrences in patients who have completed curative-intent treatment for oral cancers

Tata Memorial Centre1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2017年1月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
400
试验地点
1
主要终点
Sensitivity of a nurse led telephonic questionnaire to pick up recurrences

研究概览

简要总结

Oral cancers are thecommonest cancers in the Indian sub-continent. After finishing oncologictreatment these patients are generally followed up three monthly for first twoyears, six monthly for next three years and annually thereafter. In anyoncology set up, follow up assessment of such patients forms the major workload in the out-patient department. It has been observed that patients canidentify new symptoms indicating recurrence. Symptoms mentioned by patientshelp in diagnosing majority of recurrences (66-80%) No change was seenin DFS and OS between the groups where recurrence was detected by patientversus the doctor. In a study, where they evaluated 3645 patient visits, it wasfound that recurrence/ second primary was suspected in 5% of the patients. 79%of the patients suspected to have a recurrence had identified new symptomsthemselves. In absence of symptoms, recurrence was rare and seen in only 1.2%of the patients.  A study on head and neck cancer patients showed thatrecurrence was suspected in only 10% of patients seen routinely and in 68% ofthose who requested for a consultation. They found that 56% of those whorequested for a consultation actually had a recurrence, whereas recurrence wasfound to be there in only 0.3% of asymptomatic patients.  There are otherstudies which have shown that when followed up for 5 years, loco-regionalrecurrence may be seen in 25-50% of the patients and second primaries in3-5%  of the cases. According to another study, ‘numbers needed to see’ todetect one asymptomatic recurrence was 99.  It has been seen that even whenpatients are followed up intensively, salvage therapy remains feasible in only20-65% of them The salvage rates depend upon thesub-site and whether the recurrences are local or regional or loco-regional.Local recurrences generally fare better than regional ones. It has also beenobserved that patients tend to wait for their regular follow up rather thanpresent early when they detect a symptom. When patients with recurrences whohave been salvaged are followed up 3 and 5 year overall survival has been foundto be about 52.6% and 48% respectively. Majority of the data availableis from the more developed countries. In Indian sub-continent, the patients arenot that well educated and don’t have ample resources to make frequent longdistance trips for frequent surveillance. Data is scarce regarding the exact proportionof asymptomatic patients who are detected with recurrence on routine clinicalexamination, the salvage rates of patients detected to have recurrent diseaseand the outcomes of salvage treatment. We intend to gather data related toasymptomatic recurrences and the sensitivity of telephone based questionnairein detecting recurrences in patients of oral cancer after finishing thecurative intent treatment.

Hypothesis:A nurse led telephone-based interview can reliably identify patients at riskfor recurrence on follow up after radical treatment with oral cancers

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients having diagnosed oral cancer 2.Completed potentially curative treatment 3.On follow up for >2 months and <2 years after finishing treatment.

排除标准

  • Exclusion Criteria 1.ECOG>2 (recurrence may not be treated with curative intent) 2.<18 years, > 80 years (<18 – for consent, > 80 as recurrence may not be treated with curative intent) 3.Patients already diagnosed with recurrent disease 4.Already assessed once for the study.

结局指标

主要结局

Sensitivity of a nurse led telephonic questionnaire to pick up recurrences

时间窗: at 2 years

次要结局

  • 1. To estimate the proportion of asymptomatic patients with recurrent disease on routine (intensive) follow up(2. Salvage rate- of patients detected with recurrence)

研究者

申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验