Effect of Viewing Disney Movies During Chemotherapy on Self-Reported Quality of Life Among Patients With Gynecologic Cancer

Key Points Question Is watching Disney movies during chemotherapy associated with improved quality of life among patients with gynecologic cancer? Findings In this randomized clinical trial that included 56 patients, watching Disney movies during 6 cycles of chemotherapy was associated with differences in emotional functioning, social functioning, and fatigue status scores compared with controls. Meaning Watching Disney movies during chemotherapy may be associated with improvements in quality of life in patients with gynecologic cancer.


Summary 33
Evaluation of the influence of Disney films on the quality of life of oncological patients. 34

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Background 36 The focus of oncological therapies is primarily on efficacy and secondarily on the side effect profile. 37 In recent years, more and more studies on the quality of life (QOL) of oncological patients have been 38 conducted. 39 There are studies that measure QOL under standard therapy (1,2) as well as studies that compare QOL 40 under new drugs with standard therapy (3). Occasionally, alternative therapies were evaluated in 41 addition to known therapies (4). chemotherapy is administered over a period of 3 to 5 hours. After the application of the therapies, the 50 patients, after checking the vital parameters, are discharged into home care the same or next day, 51 depending on the chemotherapy regimen. 52 Supportive measures in pediatric oncology such as "Cliniclows" and similar are socially accepted, but 53 hardly evaluated. Patch Adams also owes us study results (7). 54 Disney films have been evaluated in some small studies on prosocial behavior (8) Patients are asked to complete the same questionnaires twice on the same day: 98 -once after ordering but before the application of chemotherapy, and 99 -a second time after the application of chemotherapy during which, depending on the randomization, a 100 Disney film was shown or the patient was not allowed to watch television. 101 This is repeated in each of the 6 planned chemotherapy cycles. Company, MPLC Austria GmbH were informed about this planned study. 110 A license, which includes a non-commercial license to screen Disney films, will be acquired by Dr. 111 Sophie Pils in case of a positive ethics vote at the beginning of the study. 112 The following films will be shown as part of this study: Lady and the Tramp, The Sword in the Stone, 113 Mary Poppins, The Jungle Book, Aristocats, Robin Hood, Cinderella and The Little Mermaid. 114 115

Questionnaire 116
The validated EORTC QLQ-C30 (Appendix 1) and the EORTC QLQ-FA12 (Appendix 2) are used to 117 evaluate QOL and fatigue. In addition, patients are asked to complete the EORTC QLQ -OV28 118 (Appendix 3), EORTC QLQ-CX24 (Appendix 4) or EORTC QLQ-EN 24 (Appendix 5) corresponding 119 to the underlying disease. 120 Answering the questionnaires takes approximately 30 minutes. 121 If any ambiguities arise during the answering of the questionnaire, the patients will be offered help by 122 Dr. Sophie Pils and the medical team of the gynecological department are available. 123 124

Risk-benefit evaluation 125
Oncological patients are routinely admitted to hospital every 3 to 4 weeks for 1 to 2 days. During these 126 stays there are longer waiting times for the patients: waiting for the visit, waiting for the 127 chemotherapy, sitting still or lying down while the chemotherapy is administered. In the days 128 following chemotherapy there is fatigue, nausea, blood count disorders, neuropathies. 129 The aim of this study is to interrupt the patients' routine and to evaluate whether this has an influence 130 on their quality of life. 131 It can be assumed that Disney films will have no negative effect on the quality of life of the patients. 132 The subjective quality of life of gynecological patients under chemotherapy is particularly relevant in 133 view of the mostly poor prognosis. 134 135

Data protection 136
The collected data is -in the context of anonymization -coded and entered into a Microsoft Excel® 137 table. 138 Only the study team has access to the non-anonymous data. 139 140

Statistics 141
For data processing, the patient's initials, date of birth, underlying disease, study group, chemotherapy 142 cycle, allergic reactions, body weight and the prestigious Disney film are provided. 143 The questionnaires are then digitized using Excel (Microsoft, Redmond, Washington, USA) and SPSS 144 (Predictive Analytics Software, SPSS Inc., Chicago, IL, USA). The results (1-7) are then evaluated 145 according to EORTC guidelines. 146