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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-30

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Quality of Life Gynaecological Cancer Lymphedema, Lower Limb Sexual Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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experimental group

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)

Group Type EXPERIMENTAL

systematic screening and early treatment

Intervention Type DIAGNOSTIC_TEST

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

control group

will follow the standard usual care guidelines at the centre where patients will be opportunistically referred to specialised care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.