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Quality of life and subsequent utilization of healthcare resources following delayed chemotherapy induced nausea and vomiting (DCINV)

in South African patients with breast cancer

Study Code: M110661

Study site no:

Patient Number:

B C

Case Report Form


Research study:
Quality of life and subsequent utilization of healthcare resources following delayed chemotherapy-induced nausea and vomiting (DCINV) in South African patients with breast cancer PRINCIPAL INVESTIGATOR: Bandela B. Mgoqi PRINCIPAL SUPERVISOR: Shirra Moch

I am confident that the information supplied in this case record form is complete and accurate data. I confirm that the study was conducted in accordance with the protocol and any protocol amendments and that written informed consent was obtained prior to the study. Investigators Signature: Date of signature: D d m m m y y y y

Division of Pharmacology Department of Pharmacy and Pharmacology School of Therapeutic Sciences Faculty of Health Sciences University of the Witwatersrand Johannesburg

Quality of life and subsequent utilization of healthcare resources following delayed chemotherapy induced nausea and vomiting (DCINV) in South African patients with breast cancer

Study Code: M110661

Study site no:

Patient Number:

B C

Subject Initials: Patient Number:

BC
CASE REPORT FORMS
INSTRUCTIONS

y y

This case report form rshould be used to record the data points for the study. Enter the study site number assigned to your institution on the top of each data collection sheet. Enter the number of each patient enrolled at your site in sequential order. For example, the first patient should be study site abbreviation-001, the second 002, the third 003, etc Enter the patients name and medical record number to assist in data collection at the specific study site.

Quality of life and subsequent utilization of healthcare resources following delayed chemotherapy induced nausea and vomiting (DCINV) in South African patients with breast cancer

Study Code: M110661

Study site no:

Patient Number:

B C

PATIENT SCREENING Please indicate by a tick ( tick 5 where applicable ) that the following have been met: Inclusion Criteria Yes No * Informed consent signed (please attach a copy of the consent to the data collection sheets) No No Patient is at least 18 years of age Patient is female

Yes Yes

*If any inclusion criteria are ticked No, then the patient is not eligible for the study Patient has been diagnosed with any of the following stages of breast stages: Carcinoma In Situ Stage I Stage II Stage III Inflammatory Stage IV Recurrent breast cancer Exclusion Criteria Patient is excluded from the study because ( tick 5 where applicable)*: Patient have been diagnosed with another cancer in addition to breast cancer Concurrent use of radiation therapy Current participation in a trial with investigational chemotherapy drugs or antiemetics Treatment with a multiple day chemotherapy regimen Pregnancy History of drug or alcohol abuse Diagnosed with a medical condition that may represent another potential aetiology for emesis and nausea Previously diagnosed Central Nervous Sytem metastasis and primary CNS cancer *If any exclusion criteria are ticked, then the patient is not eligible for the study

Quality of life and subsequent utilization of healthcare resources following delayed chemotherapy induced nausea and vomiting (DCINV) in South African patients with breast cancer

Study Code: M110661

Study site no:

Patient Number:

B C

I.
Age Race

Patient Demographics

Black

White

Coloured Height (cm)

Indian

Weight (kg) Qualification Less Matric Diploma

Matric

national certificate Masters Doctorate

Degree

II. Family History