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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03863912
Enrollment
56
Registered
2019-03-05
Start date
2017-12-01
Completion date
2018-11-29
Last updated
2019-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy, Ovarian Cancer, Quality of Life

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.

Interventions

OTHERDisney movie

Disney movie on portable DVD Player.

OTHEREORTC QLQ-C30 and EORTC QLQ-FA12 surveys

EORTC QLQ-C30 and EORTC QLQ-FA12 surveys

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of Quality of life during 6 cycles of chemotherapyMeasured 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.
Change of Fatigue during 6 cycles of chemotherapyMeasured 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.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026