Side Effects Screening and Early Intervention to Impact in Quality of Life of Gynaecological Cancer Patients

Study Overview
=================
Brief 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

Official Title
-----------------
Telemedicine-guided Patients Reported Outcome Measures (PROMs): Side Effects Screening and Early Intervention to Impact in Quality of Life of Gynaecological Cancer Patients

Conditions
-----------------
Quality of Life, Gynaecological Cancer, Lymphedema, Lower Limb, Sexual Dysfunction

Intervention / Treatment
-----------------
* Diagnostic Test: systematic screening and early treatment


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>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) | Diagnostic Test: systematic screening and early treatment<br>* 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<br>|
| No Intervention: control group<br>will follow the standard usual care guidelines at the centre where patients will be opportunistically referred to specialised care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality-of-life questionaries score | Unit on QLQ-C30 Quality-of-life scale | up to 20 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality-of-life questionaries score related to endometrial cancer | Unit on QLQ-EN-24 Quality-of-life scale | up to 20 months | 
| Quality-of-life questionaries score related to cervical cancer | Unit on QLQ-Cx-24 Quality-of-life scale | up to 20 months | 
| Quality-of-life questionaries score related to ovarian cancer | Unit on QLQ-Ov-28 Quality-of-life scale | up to 20 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
quality of life, Gynaecological cancer