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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05918770
Other study ID # Nº CEIm: 23/157
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2023
Est. completion date September 2026

Study information

Verified date June 2023
Source Hospital Universitario 12 de Octubre
Contact Blanca Gil-Ibañez, MD, PhD
Phone 0034-646886495
Email blancalabacin@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this randomized study is to assess the impact on self-perceived quality of life (QoL) of systematic screening and early treatment of aftereffects in patients with gynaecological cancers. The main question it aims to answer is if systematic screening with validated questionaries (see in detailed description), diagnosis and early treatment of lower-limb lymphoedema, anxiety-depression, sexual dysfunction and sarcopenia-malnutrition all have a positive impact on the self-perceived QoL by gynaecological cancer patients. Participants will access the screening questionnaires and QoL questionaries on a free online app on their mobile devices. In the experimental group, in case of positive screening, patients will be referred to specialised care to early treatment of the aftereffects. Researchers will compare this group with standard usual care (opportunistic treatment) to see if systematic screening and early treatment lead to a better QoL.


Description:

validated screening scales used: Gynecologic Cancer Lymphedema Questionnaire (GCLQ) Hospital Anxiety and Depression Scale (HADS) Sexual Function Abbreviated Index (IFSFA-6) Short Nutritional Assessment Questionnaire (SNAQ) Sarcopenia Formulary (SARC-F) along with self-perceived quality of life questionnaires from EORTC: QLQ-C30 EN-24 or OV-28 or CX-24


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 168
Est. completion date September 2026
Est. primary completion date September 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Women aged =18 diagnosed with ovarian, tubal and primary peritoneal, cervical and endometrial cancer who are candidates for surgery during the study period. Exclusion Criteria: - Patients unable to complete by themselves the screening questionnaires included.

Study Design


Intervention

Diagnostic Test:
systematic screening and early treatment
in case of positive screening, the online app will alert and the patient will be referred to the corresponding area for diagnosis and early treatment (Rehabilitation, Psycho-oncology, Sexual health and Nutrition

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hospital Universitario 12 de Octubre

Outcome

Type Measure Description Time frame Safety issue
Primary Quality-of-life questionaries score Unit on QLQ-C30 Quality-of-life scale up to 20 months
Secondary Quality-of-life questionaries score related to endometrial cancer Unit on QLQ-EN-24 Quality-of-life scale up to 20 months
Secondary Quality-of-life questionaries score related to cervical cancer Unit on QLQ-Cx-24 Quality-of-life scale up to 20 months
Secondary Quality-of-life questionaries score related to ovarian cancer Unit on QLQ-Ov-28 Quality-of-life scale up to 20 months
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