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

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ClinicalTrials.gov Identifier: NCT03863912
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Sophie Pils, 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.


Condition or disease Intervention/treatment Phase
Ovarian Cancer Chemotherapy Quality of Life Other: Disney movie Other: EORTC QLQ-C30 and EORTC QLQ-FA12 surveys Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of Disney Movies During Chemotherapy on QOL of Gynecologic Oncology Patients: A Prospective Study
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : April 2019


Arm Intervention/treatment
Active Comparator: Disney
watch Disney movies and fill out EORTC QLQ-C30 (Version 3) and EORTC QLQ-FA12 surveys
Other: Disney movie
Disney movie on portable DVD Player.

Other: EORTC QLQ-C30 and EORTC QLQ-FA12 surveys
EORTC QLQ-C30 and EORTC QLQ-FA12 surveys

Control
fill out EORTC QLQ-C30 (Version 3) and EORTC QLQ-FA12 surveys
Other: EORTC QLQ-C30 and EORTC QLQ-FA12 surveys
EORTC QLQ-C30 and EORTC QLQ-FA12 surveys




Primary Outcome Measures :
  1. Change of Quality of life during 6 cycles of chemotherapy [ Time Frame: 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.


  2. Change of Fatigue during 6 cycles of chemotherapy [ Time Frame: 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   only gynecological cancer patients are included
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03863912


Contacts
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Contact: Sophie Pils, MD 004314040029150 sophie.pils@meduniwien.ac.at
Contact: Johannes Ott, MD 004314040029150 johannes.ott@meduniwien.ac.at

Locations
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Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Sophie Pils, MD    004314040029150    sophie.pils@meduniwien.ac.at   
Contact: Johannes Ott, MD    004314040029150    johannes.ott@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Sophie Pils, MD Medical University of Vienna, Department of General Gynecology and Gynecologic Oncology

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Responsible Party: Sophie Pils, MD, Principal Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03863912     History of Changes
Other Study ID Numbers: 1908/2017
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No