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Trial Title:
Side Effects Screening and Early Intervention to Impact in Quality of Life of Gynaecological Cancer Patients
NCT ID:
NCT05918770
Condition:
Quality of Life
Gynaecological Cancer
Lymphedema, Lower Limb
Sexual Dysfunction
Conditions: Official terms:
Lymphedema
Conditions: Keywords:
quality of life
Gynaecological cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Single (Participant)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
systematic screening and early treatment
Description:
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
Arm group label:
experimental group
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.
Detailed 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
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 2023
Completion date:
September 2026
Lead sponsor:
Agency:
Hospital Universitario 12 de Octubre
Agency class:
Other
Source:
Hospital Universitario 12 de Octubre
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05918770
