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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03863912
• Other study ID #: 1908/2017
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: November 29, 2018

Study information

• Verified date: May 2019
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 29, 2018
• Est. primary completion date: November 29, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy
• Ovarian Cancer
• Quality of Life

Intervention

Other:
• Disney movie
Disney movie on portable DVD Player.
• EORTC QLQ-C30 and EORTC QLQ-FA12 surveys
EORTC QLQ-C30 and EORTC QLQ-FA12 surveys

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)