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

NCT03916445 | Completed

• 1 other identifier: 2019-00366
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

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?

Conditions

Gynecologic Disease; Gynecologic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• quality of life measured by questionnaire

  up to 1 year

Other Outcomes (1)

• quality of life measured by VAS in the questionnaire

  up to 1 year

Study Arms (2)

gynecological cancer

all patients having a consultation doctor during the recruiting time

Other: Connor Davidson Resilience Scale (CD-RISC 10)

chronic gynecological disease

all patients having a consultation doctor during the recruiting time

Other: Connor Davidson Resilience Scale (CD-RISC 10)

Interventions

Connor Davidson Resilience Scale (CD-RISC 10) OTHER

questionnaires about resilience (Connor Davidson Resilience Scale(CD-RISC 10)) and quality of life (EQ-5D-5L)

Also known as: EQ-5D-5L

chronic gynecological disease; gynecological cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• \- insufficient study language skills

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Universitätsspital Frauenklinik

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Genital Diseases, Female

Interventions

Connor-Davidson Resilience Scale

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Viola Heinzelmann-Schwarz, Prof. Dr. MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 16, 2019
• Study Start: March 28, 2019
• Primary Completion: April 26, 2019
• Study Completion: April 26, 2019
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)