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

NCT03863912 | Completed

• 1 other identifier: 1908/2017
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer; Chemotherapy; Quality of Life

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Study Arms (2)

Disney

ACTIVE COMPARATOR

watch Disney movies and fill out EORTC QLQ-C30 (Version 3) and EORTC QLQ-FA12 surveys

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

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

Interventions

Disney movie OTHER

Disney movie on portable DVD Player.

Disney

EORTC QLQ-C30 and EORTC QLQ-FA12 surveys OTHER

EORTC QLQ-C30 and EORTC QLQ-FA12 surveys

Control; Disney

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: only gynecological cancer patients are included
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• inadequate knowledge of the German language

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

• 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.

  PMID: 32391894 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Sophie Pils, MD

  Medical University of Vienna, Department of General Gynecology and Gynecologic Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: March 5, 2019
• Study Start: December 1, 2017
• Primary Completion: November 29, 2018
• Study Completion: November 29, 2018
• Last Updated: May 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)