Understanding Problems Faced by Parents of Children with Retinoblastoma Prior to Treatment

In early 2001, the Retinoblastoma Strategy Group, comprised of investigators from several developing countries, designed a survey of parents of children with retinoblastoma in an attempt to identify problems faced by parents prior to their child's diagnosis and to identify other factors that may have contributed to delays in diagnosis and treatment. The objectives of this on-going study are to determine whether there is an association between stage at presentation to the treatment center and the interval between the date that the first sign of disease was noticed and the date of diagnosis or treatment; to identify factors influencing these time intervals; and to determine whether such factors arise from parents' education, demographics or primary specialists health care. The survey is designed to obtain information through an interview with parents and to retrieve clinical data relating to the presentation of the child's illness.

After undergoing ethical approval both by the INCTR Ethical Review Committee and the local ethical committees at the participating institutions, the study was initiated. Nine institutions representing 6 countries (Brazil, Mexico, Turkey, India, Pakistan and Zimbabwe) have conducted interviews and collected clinical data for the study. A preliminary analysis of the 289 surveys has been performed. The majority of participants in the interview were fathers (50%). Fathers tended to be older than the mothers of these children. There were more male than female children with retinoblastoma (57% versus 43%), although Indian institutions had significantly more male patients when compared to other participating institutions. The median age of the children at the time the interview was conducted was 29 months (range 3 months to 15 years). Mothers were generally the first to notice that the child had a problem (59%), followed by other relatives (19%), then fathers (15%). After the first sign was noticed, most parents sought advice or help, the majority from ophthalmologists (70%), although in Mexico, parents tended to seek advice from family doctors or pediatricians. Approximately a third of parents sought a second opinion after receiving the initial advice. At the time of diagnosis, 39% of children had bilateral disease. Children with higher stages of disease (St Jude Stages II, III and IV) tended to be older than children with less advanced disease. Longer intervals between the time when the first sign was noticed to the date of diagnosis were also associated with higher stages of disease. Both findings suggest that the vast majority of tumors arise early in life and grow progressively in the first few years. The father's education level was positively associated with the duration of symptomatic disease - the duration was longer in fathers who were either illiterate or who only had primary school education. Fathers with lower education levels also had children with higher stages of disease. These preliminary findings suggest that public awareness campaigns must also target fathers, who have the primary decision-making role in families in developing countries.

The questionnaire component of the study was recently revised. It will continue in the countries in which it is presently ongoing, but will be expanded to institutions in other countries including Nigeria (Obafemi Awolowo University Teaching Hospital Complex, Ile-Ife) and Tanzania (Ocean Road Cancer Institute, Dar Es Salaam, Tanzania).

Melissa Adde on behalf of the Participating Investigators and Institutions: Dr. Sidnei Epelman, Santa Marcelina Hospital, Sao Paulo, Brazil; Dr. Carlos Leal, Instituto Nacional de Pediatria, Mexico City, Mexico; Dr. Emel Unal, Ankara University, Ankara, Turkey; Dr. Kamer Uysal, Dokuz Eylul University, Izmir, Turkey; Dr. LS Arya, All India Institute of Medical Sciences, Delhi, India; Dr. Anita Chandra, Cancer Institute (WIA), Chennai, India; Dr. Shripad Banavali, Tata Memorial Hospital, Mumbai, India; Dr. Alia Zaidi, Shaukat Khanum Memorial Hospital and Research Center, Lahore, Pakistan; Dr. Inam Chitsike, University of Zimbabwe, Harare, Zimbabwe.

Cervical Cancer Strategy Group Meeting Report

A meeting of the Cervical Cancer Strategy Group took place on August 6 and 7th. The meeting was attended by investigators representing institutions in 6 countries - Peru, Mexico, Tanzania, Pakistan, India and Nepal. Dr. Sankaranarayanan of the International Agency for Research on Cancer (IARC) also took part in the discussions. The objective of the meeting was to identify specific activities or studies related to screening and treatment that could be undertaken by the group.

Cervical Cancer Screening

It was agreed that an important goal for the Strategy Group is to expand population coverage using well-established approaches to the detection and treatment of CIN. Initially, these programs will be established in small selected populations as “demonstration programs”. If successful, it may be possible to catalyze wider programs in different low resource settings through the national/regional health services.

The following activities will be part of the group's strategy to expand coverage:

1. Dissemination of information to geographically proximate institutions about how to establish cervical cancer prevention programs, including the recruitment of women for screening, and to couple this, whenever possible, with hands-on training.



2. Use of established cervical cancer detection programs as regional training centers.



3. Use of existing health care infrastructure, such as smaller health centers or their equivalents, family practitioners and general hospitals, as cervical cancer screening points in a centrally coordinated program (by regional training centers).



4. Development of specific “measures of success” for screening programs such as the number of care providers trained, the number of women screened (expressed also as a fraction of women at risk within the region), CIN/cancer detection rates, and treatment rates.



5. Development of approaches to professional education about cancer prevention for medical students, nurses and health assistants, as well as gynecologists and family practitioners; meetings, training courses, educational modules within student syllabuses, and visits to screening centers will be some of the approaches taken.



6. Development of approaches to widen community involvement, including the enlistment of local and regional governmental support as well as public education and awareness campaigns.

Treatment Studies

The group expressed an interest in the development of two treatment protocols - one for early stage disease and one for locally advanced cervical cancer. Investigators from India (Drs. Dinshaw and Shanta) agreed to develop an outline of a treatment schema for patients with locally advanced cancer and investigators from Mexico and Peru (Drs. Duenas and Santos) will propose a treatment protocol for early stage cervical cancer. Other relevant details of both studies will be decided upon in a future meeting that will take place in early 2005.

An Educational Workshop: The Value and Conduct of Cancer Clinical Trials in Latin America

An educational workshop entitled, “The Value and Conduct of Cancer Clinical Trials in Latin America” was held September 1 - 3, 2004 in São Paulo, Brazil. Hosted by INCTR Brasil, it was designed in collaboration with several INCTR branches as well as the Brazilian Society of Pediatric Oncology (SOBOP), the Brazilian Society of Clinical Oncology (BSCO) and the Brazilian Cooperative Oncology Group (GBOC). Generous support was provided by Eli Lilly (which has partnered INCTR in this endeavor), Novartis, Shering AG and Baxter Oncology.

Drs. Epelman (left) and Schlusselberg take front row seats at the workshop.

The workshop focused on the science, ethics, and regulation of clinical cancer research as well as the training of data managers and research nurses. The philosophy and processes of good clinical practice and the importance of quality assurance were emphasized. It was hoped that the workshop would stimulate interest in specific areas of clinical oncology research in Latin America. The following topics were covered:

1. The pattern of cancer in Brazil and other Latin American countries.
   
   
2. Clinical trial design in cancer research.
   
   
3. Ethical and regulatory issues.
   
   
4. Implementation and management of clinical trials.
   
   
5. Development of a strategy to promote clinical trials in Latin America.
   
   
6. Training of data managers and research nurses.