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

Not Applicable

Not yet recruiting

• Conditions: Lymphedema, Lower Limb; Gynaecological Cancer; Sexual Dysfunction; Quality of Life
• Interventions: Diagnostic Test: systematic screening and early treatment

• Registration Number: NCT05918770
• Lead Sponsor: Hospital Universitario 12 de Octubre

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

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-06-23
• Last Update Submitted: 2023-06-23
• Study First Posted: 2023-06-26
• Last Update Posted: 2023-06-26
• Study Start: 2023-09
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 168

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	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)

Primary Outcome Measures

Name	Time	Method
Quality-of-life questionaries score	up to 20 months	Unit on QLQ-C30 Quality-of-life scale

Secondary Outcome Measures

Name	Time	Method
Quality-of-life questionaries score related to cervical cancer	up to 20 months	Unit on QLQ-Cx-24 Quality-of-life scale
Quality-of-life questionaries score related to ovarian cancer	up to 20 months	Unit on QLQ-Ov-28 Quality-of-life scale
Quality-of-life questionaries score related to endometrial cancer	up to 20 months	Unit on QLQ-EN-24 Quality-of-life scale