Observational study for prescription rate for cancer treatment modalities at different cancer center.
- Conditions
- CANCER
- Registration Number
- CTRI/2013/06/003769
- Lead Sponsor
- Tata Memorial hospital
- Brief Summary
**Introduction & Background**:-Cancer is expected to become an increasingly important factor in the global burden of disease in the decades to come. According to the International Agency for Research on Cancer (IARC), there were 12.6 million new cancer cases diagnosed in 2008. These numbers are projected to rise to nearly 15 million by 2015 and to over 20 million every year by 2030 (Ferlay et al., 2010). Today, about 60% of these new cases affect the developing world. By 2030, the World Health Organization (WHO) estimates that over 70% of all new cancer cases will be living in low and middle income countries (LMCs) (WHO, 2005).
This scenario prompted important actions to fight the global cancer epidemic. The resolution on cancer prevention and control approved in 2005 at the 58th World Health Assembly (WHA) undoubtedly constitutes one of those actions. The resolution challenged Ministers of Health from the 192 WHO Member States to develop and establish National Cancer Control Programmes (NCCP) tailored to socio-economic contexts, particularly for LMCs (WHA, 2005).NCCP aim to reduce incidence and mortality of cancer and to improve the quality of life of cancer patients in a defined population. These goals are expected to be achieved through systematic implementation of evidence-based strategies across the cancer control continuum, namely prevention, early detection, diagnosis, treatment and palliative care (WHO, 2002).
The main modalities of cancer treatment are surgery, chemotherapy and radiotherapy, which can be delivered with curative or palliative intent. Of those cancer patients who achieve cure,
The promotion of NCCP has had a basis on the decline of cancer mortality rate in some developed countries through the introduction of prevention and early detection programmes as well as effective treatment. In LMCs, however diagnosis of cancer is too often made at an advanced stage (Sener et al., 2005) and cancer care can be very limited by lack of human resources and adequate infrastructure. Therefore the mortality/incidence (M:I) ratio for cancer in LMCs is about 25% higher than that in the high income countries (Ferlay et al., 2010). This difference in M:I ratios is associated above all to stage at diagnosis and access to quality treatment.
The main modalities of cancer treatment are surgery, chemotherapy and radiotherapy, which can be delivered with curative or palliative intent. Of those cancer patients who achieve cure, it is estimated that 49% are cured by surgery, 40% by radiotherapy alone or combined with other modalities and 11% by chemotherapy alone or combined with other modalities *(Price* *& Sikora., 2008).*
Planning efficient and equitable treatment services for a defined population requires allocation of resources based on an estimation of demand versus resources available, particularly in low resource settings. To our knowledge, information on treatment service demand is very limited for LMCs.
Considering radiotherapy as an example, the estimates of service demand for this particular treatment modality are based on what is observed in high income countries. It is well established that radiotherapy is highly cost-effective in high income countries *(Barton et al.,*
*1995)*. However, the International Atomic Energy Agency (IAEA) has reported that nearly 30 African and Asian countries have no radiotherapy services at all *(IAEA, 2010)*. Radiotherapy significant initial capital costs require support by evidence-based studies designed to address demand in resource challenged settings.
The studies carried out to estimate radiotherapy needs show that about 50% of the patients would require radiotherapy at some point during the course of their illness *(Slotman et al.,* *2003; Delaney et al., 2005)*. These studies have considered the indication for treatment and epidemiological data from high income countries such as the Netherlands and Australia.
Patterns of cancer incidence in LMCs are distinct, thus indications for radiotherapy may vary considerably. The study in Australia provides good evidence on radiotherapy need by combining evidence-based clinical guidelines where radiotherapy was indicated as the treatment of choice and epidemiological results on the frequency of every indication for radiotherapy *(Delaney et al., 2005).* The same Australian research group estimated 55% of new cancer cases in Africa had an indication for radiotherapy *(Barton et al., 2006)*. This estimate relies on incidence data taken from GLOBOCAN and no information on the staging of the disease was available. Therefore advanced nature of cancer cases at diagnosis in LMCs might increase the radiotherapy utilization rate, because advanced tumours are unlikely to be as amenable to surgery. However, a study conducted in Sao Paulo, Brazil (upper middle income country) determined that radiation therapy was delivered in just over 40% and that surgery and chemotherapy were provided to nearly 50% of the cancer patients in a sample of 50 600 cancer cases from 2002 until January 2004 *(Gomes Junior & Almeida; 2009).* **Table 1** summarizes the studies described.
The present study aims to provide information on treatment prescription for cancer patients from reference oncological institutions located in different LMCs. It is expected that the information will provide an estimate of the cancer treatment prescription rates in LMCs and it is expected to be considered when estimating the optimal proportion of new cancer cases that should receive radiotherapy, and/or any of the other main treatment modalities. For that reason, the data should be useful in planning cancer care services and allocating resources in LMCs. Measuring which patients actually start and complete the treatment prescribed is beyond the scope of this study.
**Study methodology**
The methodology consists of extractinginformation from the medical records and/or the hospital-based cancer registryand recording the patient data onto a registration form designed by PACTProgramme Office (PPO). The registration form is simple and requestsinformation on the cancer diagnosis, date and method of diagnosis, andsubsequent treatment modality or modalities prescribed. The forms should benumbered sequentially as patient data is recorded. Only information on sex andage should be recorded for each patient. **Figure 1** illustrates which cases should beconsidered in the survey. Each institution is asked to fill in a table with allthe cases registered in the hospital (*Appendix I*). Those cases should have a **“Patient Medical FileNumberâ€**. Thisinformation will ensure that the cases were recorded chronologically andsequentially as patients were registered in the hospital. The informationcontained in this database will remain in the institution and will not beshared with PPO. Of those cases that were registered in the hospital, only thecases that have a diagnosis of cancer are recorded in the **Survey RegistrationForm**(*Appendix II*) with their respective**“Cancer PatientRegistration Numberâ€**. The institutions are asked to fill in theregistration forms for all the newly diagnosed cancer cases (excluding non-melanomaskin cancer) in achronological and sequential way. Consecutivecancer cases must be recorded starting from.1st of January 2012onwards. The cancer institutions are asked to send the collected data to PPOfor analysis in batches of 50 cases each (Appendix III)
To facilitate this process, PPO funds aninvestigator from each cancer centre to attend a Technical Meeting on 24-25 of April 2013 at IAEA Headquarters in vienna,inwhich the investigators should presentthe preliminary data (at least 50 cases) for each cancer centre. The meeting will focus on the analysis of thisdata.Recommendations and next step should be identified on how to proceed withthe study,which aims to collect similardata on a larger sample of patients diagnosed with cancer in 2012 from centre
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 33562
Inclusion Criteria: •Including newly diagnosed cancer cases of all age group (18-90) and both male and female patients in a chronological and sequential way.
Exclusion Criteria: •Excluding non-melanoma skin cancer •Those who initiated treatment in another cancer centre.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method This descriptive observational survey aims to record the prescription of cancer treatment modalities in different cancer centre Duration of 1 year
- Secondary Outcome Measures
Name Time Method NA NA
Trial Locations
- Locations (1)
Tata Memorial Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Tata Memorial Hospital🇮🇳Mumbai, MAHARASHTRA, IndiaDr Bhawna SirohiPrincipal investigator91-9930033980bhawna.sirohi@btinternet.com