Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Resilience and Quality of Life in Patients With Gynaecological Carcinomas and Chronic Gynaecological Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03916445
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
The intended pilot project aims at evaluating the feasibility and acceptability of questionnaires about resilience and quality of life in two different patient groups (either with a gynaecological carcinoma ora chronic gynaecological disease). The results provided by this pilot study will build the basis of an upcoming, larger project including these questionnaires and the main objective of assessing resilience. More precisely, the study aims at answering the following questions. How is the overall resilience and quality of life in the target population at one assessment point? Are the instruments used in this pilot feasible for the target population when assessing resilience and quality of life?

Condition or disease Intervention/treatment
Gynecologic Disease Gynecologic Cancer Other: Connor Davidson Resilience Scale (CD-RISC 10)

Layout table for study information
Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Resilience and Quality of Life in Patients With Gynaecological Carcinomas and Chronic Gynaecological Diseases: A Pilot Study
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : April 25, 2020
Estimated Study Completion Date : May 25, 2020

Group/Cohort Intervention/treatment
gynecological cancer
all patients having a consultation doctor during the recruiting time
Other: Connor Davidson Resilience Scale (CD-RISC 10)
questionnaires about resilience (Connor Davidson Resilience Scale(CD-RISC 10)) and quality of life (EQ-5D-5L)
Other Name: EQ-5D-5L

chronic gynecological disease
all patients having a consultation doctor during the recruiting time
Other: Connor Davidson Resilience Scale (CD-RISC 10)
questionnaires about resilience (Connor Davidson Resilience Scale(CD-RISC 10)) and quality of life (EQ-5D-5L)
Other Name: EQ-5D-5L




Primary Outcome Measures :
  1. resilience measured by questionnaire [ Time Frame: up to 1 year ]
    Total Score of the resilience questions is 0 to 40, 10 subscales from 0 to 4 (summed up for total score), the higher the score the better the resilience


Secondary Outcome Measures :
  1. quality of life measured by questionnaire [ Time Frame: up to 1 year ]
    Questions about Quality of life: Total score 0-25, 5 subscales 0 to 5 (summed up for total score), the higher the score the lower is Quality of life.


Other Outcome Measures:
  1. quality of life measured by VAS in the questionnaire [ Time Frame: up to 1 year ]
    visual analogue scale (VAS) about Feeling healthy: Score 0 to 100 the higher the score the better is Quality of life



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
female patients with a chronic gynecological disease or a gynaecological carcinoma, currently treated at the hospital
Criteria

Inclusion Criteria:

  • female,
  • >18 years old,
  • german speaking

exclusion criteria:

- insufficient study language skills


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): NCT03916445


Contacts
Layout table for location contacts
Contact: Verena Ehrbar, PhD +41 61 328 79 62 verena.ehrbar@usb.ch

Locations
Layout table for location information
Switzerland
Universitätsspital Frauenklinik Recruiting
Basel, Basel-Stadt, Switzerland, 4031
Contact: Corinne Urech, PhD       corinne.urech@usb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Layout table for investigator information
Principal Investigator: Viola Heinzelmann-Schwarz, Prof. Dr. MD University Hospital, Basel, Switzerland

Layout table for additonal information
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03916445     History of Changes
Other Study ID Numbers: 2019-00366
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Genital Diseases, Female