Clinical trial · Interventional
Side Effects Screening and Early Intervention to Impact in Quality of Life of Gynaecological Cancer Patients
Telemedicine-guided Patients Reported Outcome Measures (PROMs): Side Effects Screening and Early Intervention to Impact in Quality of Life of Gynaecological Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynaecological Cancer | — | UNRESOLVED | — |
| Lymphedema, Lower Limb | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Sexual Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| systematic screening and early treatment | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 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)
- interventionNames
- Diagnostic Test: systematic screening and early treatment
- type
- NO_INTERVENTION
- label
- control group
- description
- will follow the standard usual care guidelines at the centre where patients will be opportunistically referred to specialised care
Primary outcomes (1)
- measure
- Quality-of-life questionaries score
- timeFrame
- up to 20 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDGil-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