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

Not Applicable

Completed

• Conditions: Chemotherapy; Quality of Life; Ovarian Cancer
• Interventions: Other: Disney movie; Other: EORTC QLQ-C30 and EORTC QLQ-FA12 surveys

• Registration Number: NCT03863912
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-01
• Primary Completion: 2018-11-29
• Study Completion: 2018-11-29
• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-03-03
• Study First Posted: 2019-03-05
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-01
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

• planned 6 cycles of chemotherapy with carboplatin/paclitaxel or carboplatin/pegylated liposomal doxorubicin
• Age >18 years

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Exclusion Criteria

• inadequate knowledge of the German language

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Disney	EORTC QLQ-C30 and EORTC QLQ-FA12 surveys	watch Disney movies and fill out EORTC QLQ-C30 (Version 3) and EORTC QLQ-FA12 surveys
Control	EORTC QLQ-C30 and EORTC QLQ-FA12 surveys	fill out EORTC QLQ-C30 (Version 3) and EORTC QLQ-FA12 surveys
Disney	Disney movie	watch Disney movies and fill out EORTC QLQ-C30 (Version 3) and EORTC QLQ-FA12 surveys

Primary Outcome Measures

Name	Time	Method
Change of Fatigue during 6 cycles of chemotherapy	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)	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.
Change of Quality of life during 6 cycles of chemotherapy	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)	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.

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria