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

Madrid Health Service

Status: Not yet enrolling

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

Treatments: Diagnostic Test: systematic screening and early treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05918770

Nº CEIm: 23/157

Details and patient eligibility

About

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.

Full 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

Enrollment: 168 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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168 participants in 2 patient groups

experimental group

Experimental group

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)

Treatment:

Diagnostic Test: systematic screening and early treatment

control group

No Intervention group

Description:

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