Abstract: Objective:To develop a questionnaire on the medical needs and satisfaction of patients with malignant tumors and test its reliability and validity.Methods:The initial item pool of the questionnaire was selected to form alternative evaluation indicators using literature research method.Del Phi expert consultation method was used to establish formal evaluation indicators after screening candidate indicators, and 50 local cancer radiotherapy patients were investigated to test the reliability and validity of the questionnaire.Results:The questionnaire had 8 dimensions and 32 items.The Kaiser-Meyer-Olkin (KMO) values for the forward and reverse questions were all greater than 0.40, the P-values were all less than 0.05, and the cumulative variance contributions of the common factors were all greater than 80.00%; the reliability of each module of the questionnaire was above 0.60, and the Cronbach’s α coefficient of the total scale was 0.89.Conclusion:The self-designed questionnaire has good reliability and validity, and can be used to explore the qualitative attributes and degree of needs of patients undergoing radiotherapy for malignant tumours.