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Not yet recruiting NCT05918770

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

No phase Interventional Quality of Life Gynaecological Cancer Lymphedema, Lower Limb Sexual Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: systematic screening and early treatment.
Who it may be relevant to
Registry conditions: Quality of Life, Gynaecological Cancer, Lymphedema, Lower Limb, Sexual Dysfunction. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

  • Diagnostic test 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

  • Quality-of-life questionaries score [Time frame: up to 20 months]
Secondary outcome measures (3)
  • Quality-of-life questionaries score related to endometrial cancer [Time frame: up to 20 months]
  • Quality-of-life questionaries score related to cervical cancer [Time frame: up to 20 months]
  • Quality-of-life questionaries score related to ovarian cancer [Time frame: up to 20 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Gil-Ibanez B, Tejerizo-Garcia A, Oliver MR, Madariaga A, Maiz Jimenez M, Gil Garcia A, Lopez-Gonzalez G. Side effects screening and early intervention to impact in quality of life of patients with gynecological cancers (HALIS study). Int J Gynecol Cancer. 2023 Oct 2;33(10):1645-1648. doi: 10.1136/ijgc-2023-004802. PMID 37748803

Identifiers

NCT: NCT05918770 · Nº CEIm: 23/157

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗