Gynecologic DiseaseNCT03916445
Resilience and Quality of Life in Patients With Gynaecological Carcinomas and Chronic Gynaecological Diseases
An observational study of Gynecologic Disease and Gynecologic Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Disease, Gynecologic Cancer
- What is being tested?
- Connor Davidson Resilience Scale (CD-RISC 10)
- How many people
- 132 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Mar 2019to 26 Apr 2019
- Phase
- Observational
- 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
Study population: female patients with a chronic gynecological disease or a gynaecological carcinoma, currently treated at the hospital
Who may be able to join
- female,
- >18 years old,
- german speaking
Who cannot join
- insufficient study language skills
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Universitätsspital Frauenklinik
Basel, Canton of Basel-City, 4031
About this study
Official title: 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?
- Conditions
- Gynecologic Disease, Gynecologic Cancer
- Being tested
- Connor Davidson Resilience Scale (CD-RISC 10)
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connor Davidson Resilience Scale (CD-RISC 10)Other
Also called EQ-5D-5L
questionnaires about resilience (Connor Davidson Resilience Scale(CD-RISC 10)) and quality of life (EQ-5D-5L)
| Study group | Role | What they receive |
|---|---|---|
| gynecological cancer | all patients having a consultation doctor during the recruiting time Receives: Other: Connor Davidson Resilience Scale (CD-RISC 10) | |
| chronic gynecological disease | all patients having a consultation doctor during the recruiting time Receives: Other: Connor Davidson Resilience Scale (CD-RISC 10) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 1 year
Secondary outcomes (1)
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.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start28 Mar 2019
- Primary completion26 Apr 2019
- Study completion26 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Viola Heinzelmann-Schwarz, Prof. Dr. MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916445
- Sponsor's protocol ID
- 2019-00366
- Other IDs
- 2019
- Status last verified
- Jun 2020
- First submitted
- 10 Apr 2019
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resilience and Quality of Life in Patients With Gynaecological Carcinomas and Chronic Gynaecological Diseases: A Pilot Study
- ClinicalTrials.gov ID
- NCT03916445
- Acronym / sponsor ID
- 2019-00366
- Conditions
- Gynecologic Disease, Gynecologic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 26 Apr 2019 (actual)
- First posted
- 16 Apr 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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gynecological cancer | – | Other: Connor Davidson Resilience Scale (CD-RISC 10)all patients having a consultation doctor during the recruiting time |
| chronic gynecological disease | – | Other: Connor Davidson Resilience Scale (CD-RISC 10)all patients having a consultation doctor during the recruiting time |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- female patients with a chronic gynecological disease or a gynaecological carcinoma, currently treated at the hospital
Key inclusion criteria (3 listed)
- female,
- >18 years old,
- german speaking
Key exclusion criteria (1 listed)
- insufficient study language skills
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 |
|---|---|---|
| Connor Davidson Resilience Scale (CD-RISC 10)Also: EQ-5D-5Lquestionnaires about resilience (Connor Davidson Resilience Scale(CD-RISC 10)) and quality of life (EQ-5D-5L) | Other | chronic gynecological disease, gynecological cancer |
Primary outcome
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
1 secondary outcome
quality of life measured by questionnaire
Time frame: up to 1 year
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 4 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Gynecologic Disease
Recruiting
Methylation Analyses for Gynaecological Research Through Home-based Self-sampling
Healthy Adult Participants, Gynecological Disease
Recruiting
INtegrating Systematic PatIent-Reported Evaluations in Multi-Disciplinary Tumor Boards: The INSPIRE Study
Breast Cancer, Corpus Uteri Cancer
RecruitingObservational study
GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications
GYN Disorders
Not yet recruiting
Gut Microbiome in Patients With Lung and Melanoma Cancer and Intestinal Microbiota in Gynecologic Cancers
Non Small Cell Lung Cancer, Melanoma (Skin Cancer)
Enrolling by invitation
Peer Ambassador in Gyn Onc Trials
Ovarian Cancer
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.
Viola Heinzelmann-Schwarz, Prof. Dr. MD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Disease and Gynecologic Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 3 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 4 Jun 2020. 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 Switzerland. 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?
resilience measured by questionnaire (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2020.