Impact of Disney Movies During Chemotherapy on QOL of Gynecologic Oncology Patients

Study Overview
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Brief Summary
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To evaluate the impact of Disney movies on quality of life (QOL) of gynecologic oncology patients. 25 Patients are watching Disney movies on portable DVD players during chemotherapy, 25 patients are not allowed to watch TV. EORTC QLQ-C30 and EORTC QLQ-FA12 surveys are given to the patients before and after the six chemotherapies. Hypothesis: Disney movies can elevate patients QOL.

Official Title
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Impact of Disney Movies During Chemotherapy on QOL of Gynecologic Oncology Patients: A Prospective Study

Conditions
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Ovarian Cancer, Chemotherapy, Quality of Life

Intervention / Treatment
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* Other: Disney movie
* Other: EORTC QLQ-C30 and EORTC QLQ-FA12 surveys


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: planned 6 cycles of chemotherapy with carboplatin/paclitaxel or carboplatin/pegylated liposomal doxorubicin Age >18 years Exclusion Criteria: inadequate knowledge of the German language

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Disney<br>watch Disney movies and fill out EORTC QLQ-C30 (Version 3) and EORTC QLQ-FA12 surveys | Other: Disney movie<br>* Disney movie on portable DVD Player.<br>Other: EORTC QLQ-C30 and EORTC QLQ-FA12 surveys<br>* EORTC QLQ-C30 and EORTC QLQ-FA12 surveys<br>|
| Other: Control<br>fill out EORTC QLQ-C30 (Version 3) and EORTC QLQ-FA12 surveys | Other: EORTC QLQ-C30 and EORTC QLQ-FA12 surveys<br>* EORTC QLQ-C30 and EORTC QLQ-FA12 surveys<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Quality of life during 6 cycles of chemotherapy | To compare change in Quality of Life, as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30 (Version 3)) during 6 cycles of chemotherapy. The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 (Not at all), 2 (A little), 3 (Quite a bit) and 4 (Very much). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 (very poor) to 7 (excellent). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome. | Measured before and after each chemotherapy (at baseline and on average after 3, 6, 9, 12, 15 weeks after inclusion in patients with carboplatin/paclitaxel or after 4, 8, 12, 16, 20 weeks after inclusion in patients with carboplatin/doxorubicin) | 
| Change of Fatigue during 6 cycles of chemotherapy | To compare change in Fatigue, as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Fatigue (EORTC QLQ-FA12) during 6 cycles of chemotherapy. The EORTC QLQ-FA12 uses for the questions 1 to 12 a four-point scale. The scale scores from 1 to 4: 1 (Not at all), 2 (A little), 3 (Quite a bit) and 4 (Very much). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. Raw score has to be calculated using the mean value for the questions 1 to 12. | Measured before and after each chemotherapy (at baseline and on average after 3, 6, 9, 12, 15 weeks after inclusion in patients with carboplatin/paclitaxel or after 4, 8, 12, 16, 20 weeks after inclusion in patients with carboplatin/doxorubicin) |