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

Resilience and Quality of Life in Patients With Gynaecological Carcinomas and Chronic Gynaecological Diseases: A Pilot Study

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?

Study Overview

• Status: Completed
• Conditions: Gynecologic Cancer; Gynecologic Disease
• Intervention / Treatment: Other: Connor Davidson Resilience Scale (CD-RISC 10)

• Study Type: Observational
• Enrollment (Actual): 132

Contacts and Locations

Study Locations

• Switzerland
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4031
      • Universitätsspital Frauenklinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

female patients with a chronic gynecological disease or a gynaecological carcinoma, currently treated at the hospital

Description

Inclusion Criteria:

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

exclusion criteria:

- insufficient study language skills

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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 Names: 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 Names: EQ-5D-5L

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
resilience measured by questionnaire	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	up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of life measured by questionnaire	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.	up to 1 year

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Viola Heinzelmann-Schwarz, Prof. Dr. MD, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 28, 2019
• Primary Completion (ACTUAL): April 26, 2019
• Study Completion (ACTUAL): April 26, 2019

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: April 11, 2019
• First Posted (ACTUAL): April 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2019-00366

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No