A Cross-Sectional Feasibility Study of a Telephonic Questionnaire By Research Nurses For Follow-Up Of Locally Advanced Cervical Cancer Patients With Complete Response To Treatment.
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 主要终点
- Accuracy of nurse-led telephonic interview for disease recurrence
研究概览
简要总结
Cross-sectional Feasibility study on all consecutive patients of locally advanced cancer of the cervix or vault treated entirely at Tata Memorial Centre with curative intent radiation or chemoradiation.
详细描述
Our institution registers on an average 670 cases of cancer cervix in a year and almost 75% are treated with curative intent, therefore around 500 patients a year would be treated with curative intent. Assuming that 75% of patients registered in a year would be receiving treatment at our institute, 375 patients a year would be completing treatment, of whom the investigator expect 80-85% ,i.e 300 patients to have a complete response. The list of patients who have completed radio(chemotherapy) in 2015 &2016 can be obtained from the Radiation Oncology Department records. Patients identified for a follow up visit will be telephonically contacted between one and two weeks before the planned clinic visit and verbal telephonic consent taken prior to the nurse-led interview. This study should be able to accrue 300 patients in 6 months.
Patients of locally advanced cervical cancer or vault cancer who have been treated with radiotherapy with or without concurrent chemotherapy and have a clinical complete response at 3 months post treatment and are within the first 2 years post treatment completion will be eligible to participate in this study.
Screening: Patients will be screened from the list of patients treated in the radiotherapy department over the last 2 years (2015-2016), available from the Radiation Oncology Information System (ROIS). All patients with a diagnosis of cervical cancer or vault cancer will be screened using the hospital Electronic Medical Record (EMR) to check stage of disease, schedule of treatment received, response at 3 months post treatment and expected date of next follow up.
If patient fulfils all inclusion criteria, she will be called by the research nurse, approximately 1-2 weeks prior to her expected date of follow up, for a preliminary conversation and invited to participate in the study.
After verbal telephonic consent is obtained, she will be interviewed by the clinical research nurse using the format of the prepared proforma (Form A) regarding symptoms suggestive of disease recurrence as well as treatment induced toxicity. At the end of the interview, the research nurse records her impression of whether the patient has worrisome symptoms of disease or not and has symptoms of treatment toxicity or not for which she should visit the hospital.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cervical Cancer Stage Ib2, II and III (Squamous carcinoma or adenocarcinoma)
- •Cancer of the vault
- •Cancer of the cervix which inadvertently underwent hysterectomy (inadequate surgery)
- •Treated with curative intent with radical radio(chemo)therapy or NACT followed by radical radio(chemo)therapy and completed all curative treatment.
- •Within 2 years post completion of treatment
- •Has complete clinical response at 3 months post treatment
- •Informed consent
- •Contactable by telephone
排除标准
- •Patients with Stage III disease treated with palliative intent with once monthly radiotherapy
- •Early stage cervical cancer patients who underwent Wertheims hysterectomy and who have completed adjuvant radiochemotherapy due to high-risk factors
- •Metastatic cervical cancers
- •Patients who are unable to comprehend the questions or dialogue over telephone by medical staff.
- •Patients who seem unreliable for follow up
结局指标
主要结局
Accuracy of nurse-led telephonic interview for disease recurrence
时间窗: 1 YEAR
To estimate the accuracy of nurse-led telephonic interview in identifying patients with symptoms suggestive of disease recurrence, in terms of sensitivity and specificity values
次要结局
- Acceptability of a nurse-led telephonic surveillance program using structured format (Form C).(1 YEAR)
- Accuracy of nurse-led telephonic interview for late toxicity of treatment(1 YEAR)
研究者
Dr Umesh Mahantshetty
Professor Dr.
Tata Memorial Hospital
