Ovarian CancerNCT03863912
Impact of Disney Movies During Chemotherapy on QOL of Gynecologic Oncology Patients
A study testing Disney movie and EORTC QLQ-C30 and EORTC QLQ-FA12 surveys in people with Ovarian Cancer and Chemotherapy, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Chemotherapy, Quality of Life
- What is being tested?
- Disney movie and EORTC QLQ-C30 and EORTC QLQ-FA12 surveys
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2017to 29 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- planned 6 cycles of chemotherapy with carboplatin/paclitaxel or carboplatin/pegylated liposomal doxorubicin
- Age >18 years
Who cannot join
- inadequate knowledge of the German language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Disney Movies During Chemotherapy on QOL of Gynecologic Oncology Patients: A Prospective Study
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.
- Conditions
- Ovarian Cancer, Chemotherapy, Quality of Life
- Being tested
- Disney movie, EORTC QLQ-C30 and EORTC QLQ-FA12 surveys
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disney movieOther
Disney movie on portable DVD Player.
EORTC QLQ-C30 and EORTC QLQ-FA12 surveysOther
EORTC QLQ-C30 and EORTC QLQ-FA12 surveys
| Study group | Role | What they receive |
|---|---|---|
| Disney | Active comparator | watch Disney movies and fill out EORTC QLQ-C30 (Version 3) and EORTC QLQ-FA12 surveys Receives: Other: Disney movie; Other: EORTC QLQ-C30 and EORTC QLQ-FA12 surveys |
| Control | Other | fill out EORTC QLQ-C30 (Version 3) and EORTC QLQ-FA12 surveys Receives: Other: EORTC QLQ-C30 and EORTC QLQ-FA12 surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start1 Dec 2017
- Primary completion29 Nov 2018
- Study completion29 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sophie Pils, Medical University of Vienna
- Investigators
- Sophie Pils, MD, Principal investigator, Medical University of Vienna, Department of General Gynecology and Gynecologic Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863912
- Sponsor's protocol ID
- 1908/2017
- Status last verified
- May 2019
- First submitted
- 25 Feb 2019
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pils S, Ott J, Reinthaller A, Steiner E, Springer S, Ristl R. Effect of Viewing Disney Movies During Chemotherapy on Self-Reported Quality of Life Among Patients With Gynecologic Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2020 May 1;3(5):e204568. doi: 10.1001/jamanetworkopen.2020.4568.
PubMed 32391894
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Disney Movies During Chemotherapy on QOL of Gynecologic Oncology Patients: A Prospective Study
- ClinicalTrials.gov ID
- NCT03863912
- Acronym / sponsor ID
- 1908/2017
- Conditions
- Ovarian Cancer, Chemotherapy, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 29 Nov 2018 (actual)
- Study completion
- 29 Nov 2018 (actual)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disney | Active comparator | Other: Disney movie, Other: EORTC QLQ-C30 and EORTC QLQ-FA12 surveyswatch Disney movies and fill out EORTC QLQ-C30 (Version 3) and EORTC QLQ-FA12 surveys |
| Control | Other | Other: EORTC QLQ-C30 and EORTC QLQ-FA12 surveysfill out EORTC QLQ-C30 (Version 3) and EORTC QLQ-FA12 surveys |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- planned 6 cycles of chemotherapy with carboplatin/paclitaxel or carboplatin/pegylated liposomal doxorubicin
- Age >18 years
Key exclusion criteria (1 listed)
- inadequate knowledge of the German language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disney movieDisney movie on portable DVD Player. | Other | Disney |
| EORTC QLQ-C30 and EORTC QLQ-FA12 surveysEORTC QLQ-C30 and EORTC QLQ-FA12 surveys | Other | Control, Disney |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Derived from this study: PubMed 32391894Pils S, Ott J, Reinthaller A, Steiner E, Springer S, Ristl R. Effect of Viewing Disney Movies During Chemotherapy on Self-Reported Quality of Life Among Patients With Gynecologic Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2020 May 1;3(5):e204568. doi: 10.1001/jamanetworkopen.2020.4568.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Pils, MD principal investigator
Medical University of Vienna, Department of General Gynecology and Gynecologic Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disney movie and EORTC QLQ-C30 and EORTC QLQ-FA12 surveys in people with Ovarian Cancer and Chemotherapy, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03863912, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.