Compliance to Cervical Cancer Chemoradiation Guidelines: A Multicentric Implementation Audit and Resource Assessment Initiative of National Cancer Grid of India

Официальное название

Compliance to Cervical Cancer Chemoradiation Guidelines: A Implementation Audit and Resource Assessment Initiative of National Cancer Grid of India

Обзор

This is a combination of retrospective and prospective observational study that will be performed across NCG and other participating centers to report compliance to chemoradiation for cervical cancer. This audit will include patients treated with standard of care treatment, in this case definitive or adjuvant radiation+/- concurrent chemotherapy will be included. Patients recruited in various institutions in prospective clinical trials will not be included. The participating centersthat agree to contribute data will include all registered cases over a 6-month period that have been diagnosed with cervical cancer wherein treatment is planned with radical dose radiation and/or concurrent chemotherapy. Centers that do not have retrospective data of the patients will contribute data of patients registered prospectively over 6 months. Furthermore, any cases referred to the institution for brachytherapy alone will also be included. As a first step member institutions that participated in guideline development process or provide an agreement to guidelines adherence will be audited. The project will be submitted in institutional ethics committees with memorandum of understanding for anonymized data sharing. Each of the co-investigators listed from contributing centers will be directly responsible for collecting data contribution and accuracy of data submitted. Those centres which cannot or do not want to participate will be requested to provide data on only compliance outcomes to treatment for at least of 5 consecutively patients diagnosed with cervical cancer wherein treatment is planned with radical dose radiation and /or concurrent chemotherapy over a period of 6 months.

Подробное описание

Investigator intend to use electronic case record form (e-CRF) created using on line portal (google e-forms) wherein details of patients treated within the 6 month period will be captured. Google e-CRF will be available to all participating centres free of charge and has ease of access for filling details on both computer, tablets or mobile phone platforms. The e-form is user friendly and provides automated excel output and basic trends of responses and is ideal to be used across busy departments and low resource settings.

To maintain data security, no patient identifying information will be collected. Each institution will be provided an institution id and name identifiers will not be used. Similarly a code will be generated for each of the patient and details of that code will remain with the parent institution.

Вмешательства

• Другое Not applicable- observational study
  Compliance to Cervical Cancer Chemoradiation treatment guidelines

Первичные конечные точки

• report on institutional compliance to National Cancer Grid cervical cancer guidelines for chemo-radiation. [Срок оценки: 3 Months]

Вторичные конечные точки (3)

• To report on factors impacting compliance to standard guidelines [Срок оценки: 3years]
• To report adequacy of infrastructural and manpower requirements for optimal treatment of cervical cancer in NCG centres and corresponding state of origin [Срок оценки: 3 years]
• To compute relative risk of suboptimal treatment for cervical cancer in reference to infrastructural and manpower deficits [Срок оценки: 3 years]

Критерии участия

The participating centers that agree to contribute data will include all registered cases over a 6 month period that have been diagnosed with histologically proven cervical cancer wherein either radical, adjuvant or palliative radiation with or without concurrent or systemic chemotherapy is planned.

Furthermore any cases referred to the institution for brachytherapy alone will also be included.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Индия · 2 центра

• Tata Memorial Hospital — Mumbai
• Tata Memorial Hospital — Mumbai

Публикации

• Dr. V. K. Srivastava, Dr Tanvir Kaur, Dr. S Shrisvastava () CONSENSUS DOCUMENT FOR THE MANAGEMENT OF CANCER CERVIX, Available at: https://www.icmr.nic.in > sites > default > files > reports > Cervix Cance (Accessed: 12th December 2019).
• IAEA staffing estimator. http://nucleus.iaea.org/HHW/RadiationOncology/making the case for radiotherapy in your country/role of radiotherapy in cancer care/radiotherapy is a cost effective system which needs balance/index.html.
• IPEM recommendations for the provision of physics services to radiotherapy. http://ipem.ac.uk/portals/0/documents/recommendations.
• Budiharto T, Musat E, Poortmans P, Hurkmans C, Monti A, Bar-Deroma R, Bernstein Z, Tienhoven Gv, Collette L, Duclos F, Davis B, Aird E; EORTC Radiation Oncology Group. Profile of European radiotherapy departments contributing to the EORTC Radiation Oncology Group (ROG) in the 21st century. Radiother Oncol. 2008 Sep;88(3):403-10. doi: 10.1016/j.radonc.2008.05.013. Epub 2008 Jun 4. PMID 18538427
• International Atomic Energy Agency. Planning national radiotherapy services: a practical tool. IAEA human health series number 14. Vienna International Atomic Energy Agency;2010. ISBN 978-92-0-1059 10-9.
• Nandakumar A, Kishor Rath G, Chandra Kataki A, Poonamalle Bapsy P, Gupta PC, Gangadharan P, Mahajan RC, Nath Bandyopadhyay M, Kumaraswamy, Vallikad E, Visweswara RN, Selvaraj Roselind F, Sathishkumar K, Daniel Vijaykumar D, Jain A, Lakshminarayana Sudarshan K. Concurrent Chemoradiation for Cancer of the Cervix: Results of a Multi-Institutional Study From the Setting of a Developing Country (India) PMID 28804767
• Grover S, Gudi S, Gandhi AK, Puri PM, Olson AC, Rodin D, Balogun O, Dhillon PK, Sharma DN, Rath GK, Shrivastava SK, Viswanathan AN, Mahantshetty U. Radiation Oncology in India: Challenges and Opportunities. Semin Radiat Oncol. 2017 Apr;27(2):158-163. doi: 10.1016/j.semradonc.2016.11.007. Epub 2016 Nov 14. PMID 28325242
• Banerjee S, Mahantshetty U, Shrivastava S. Brachytherapy in India - a long road ahead. J Contemp Brachytherapy. 2014 Oct;6(3):331-5. doi: 10.5114/jcb.2014.45761. Epub 2014 Oct 6. PMID 25337139

Идентификаторы

NCT: NCT07290972 · TMC IEC III 900537

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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