Melissa Adde, Director of INCTR’s Clinical Trials Office and Dr Udo Bode, Director of INCTR’s
Pediatric Oncology Program for East Africa visited Tanzania from September 28th to October 5th. The purpose of this visit was:
- To perform site visits of the pediatric oncology wards at Bugando Medical Center (BMC) in Mwanza and the Muhimbili National Hospital (MNH) in order to confirm the suitability of the facilities for managing the clinical care of children enrolled on the INCTR Burkitt lymphoma (BL) protocol at both institutions. Pediatric oncology patients from the Ocean Road Cancer Institute (ORCI) were transferred to MNH earlier this year.
- To monitor the progress being made on the BL protocol
- To assess the quality of the data being collected
- To provide training to personnel in data management procedures, including care report form completion and in the use of the study database, particularly for BMC
- To discuss selected patients and to provide training to personnel involved in the clinical management of the patients.
The following diary outlines what was accomplished during this visit.
Dar es Salaam, September 28th
Dr Bode and Ms Adde met with the research team members including the Principal Investigator (PI), Dr Twalib Ngoma at ORCI who are responsible for the conduct of the protocol. During this meeting, the current data management processes as key personnel previously involved in direct patient care of these children, case report form (CRF) completion and data entry, have changed and the pediatric oncology patients were transferred to Muhimbili National Hospital (MNH), while data management staff remained at ORCI. They had an opportunity to review the study data base with the data managers and to answer any questions about data entry procedures that the data managers had. Outstanding data queries were discussed and resolved.
Mwanza, September 29th and 30th
During these two days, Melissa Adde and Dr Bode met with Dr Nestory Masalu, a medical oncologist working at BMC who is the PI for the BL protocol at BMC and his research team. BMC recently became a participating institution in the protocol. Dr Masalu gave them a tour of the facilities including the main clinical laboratory, the pathology department, the surgical ward, the pediatric intensive care unit and the main oncology ward which accommodates 24 patients. Patients requiring out-patient chemotherapy also come to the ward to receive chemotherapy. In addition to the nurses assigned to the ward, he has three nurses specially trained in the safe preparation and administration of chemotherapy. He provided them with a report of project-related expenditures to date and showed them the office where equipment purchased for the study, such as the computer and filing cabinets were stored.
Patient accrual began in mid July of 2011 and so far, 7 patients have been entered onto the study. They met many of the patients. The ward was well organized. Each child had their own bed and was accompanied by a parent. Although INCTR provides chemotherapy for protocol patients, other aspects of their care are not free. Families of these patients are very poor and have to bear the burden of other costs associated with treatment, such as routine laboratory tests, biopsies, bone marrow aspirates, cerebrospinal fluid cytospins, intravenous fluids and needles, and food. The first child entered onto the protocol had an outstanding bill of roughly $250 which was preventing her discharge from the hospital. Dr Masalu explained that he spends each Tuesday before a hospital committee trying to negotiate reduced hospital charges for all cancer patients. Ms Adde met the social worker who was recently hired who will assist Dr Nestory in obtaining funds to support the cancer patients and in providing psychosocial support.
Information gained will be used in future discussions with a partner NGO which provides support to children with cancer in Tanzania in order to develop a strategy with the partner NGO for meeting needs of both children with cancer and their families.
They reviewed the CRFs for all of the children entered on study to date. The correct sequence for form completion was discussed. The corresponding medical records were reviewed and data recorded documenting registration and pre-treatment data were validated. Informed consent documents were checked and all were obtained in accordance with procedures outlined in the protocol.
They discussed some difficult patient cases with the team – including the fact that 3 of the 7 protocol patients developed malaria in the hospital while undergoing treatment. Rounds were made on three newly admitted possible BL patients who were awaiting confirmation of their diagnosis. These children had extensive disease.
The study database was installed for the team. Dr Valerie, who is responsible for CRF completion, was trained in the use of the database system. All 7 protocol patients were registered in the study database.
Dar es Salaam, October 1st
Melissa Adde met with the two data managers and the patient tracking officer at the INCTR Tanzania Office at ORCI. She reviewed selected CRFs and medical records for several of the protocol patients for the purposes of data verification. It was noted that there are difficulties in grading toxicities related to laboratory findings. Training in toxicity grading was given to both data managers. Proper procedures for making changes to CRFs and for submitting “correction logs” to INCTR were reviewed. Plans for home visits were made. It was learned that the 500th patient was enrolled on the protocol at MNH during the day.
Dar es Salaam, October 3rd through the 5th
On Monday, Dr Bode, Ms Adde and Ms Devotha, the data manager went to MNH. They and took the CRF books from ORCI in order to complete the CRFs for patients currently undergoing treatment at MNH whose medical records were at the hospital and to verify the CRF data with these medical records. The day was spent with Dr Paul and Ms Devotha to review the medical records and to complete CRFs together. Training was provided in error correction on CRFs. Training in toxicity grading was provided and the data manager was supervised in CRF completion of portions of the forms such as recording labs and determining laboratory toxicity grades. The interpretation of sites of disease at presentation was reviewed, particularly orbital involvement which has been documented as “protrusion of the eye”.
On Tuesday, Dr Bode, Dr Scanlan and Dr Ngoma accompanied Melissa Adde for an official de-brief with Dr Elizabeth Marum, the Acting Country Officer for Tanzania of CDC. Ms Adde provided a brief overview of the work presently being done in Africa and the results of the Burkitt lymphoma protocol. The survival data was presented and photographs were shown to Dr Marum that demonstrated how rapidly this tumor responds to treatment.
On Wednesday, Ms Adde met with the Abbott Fund which has provided support for the renovation of the pediatric oncology ward at MNH. Following this, Dr Bode and Ms Adde were given a formal tour of the pediatric oncology ward at MNH by Dr Trish Scanlan. This tour included the downstairs ward where children can receive out-patient chemotherapy or await laboratory results, the 11 bed in-patient unit on the 2nd floor, and the children’s playroom and school room - which were beehives of activity. It is a much improved environment and facility for children with cancer. They had a final meeting with Dr Ngoma prior to their departure.