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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | 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 | No Intervention | will follow the standard usual care guidelines at the centre where patients will be opportunistically referred to specialised care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| systematic screening and early treatment | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality-of-life questionaries score | Unit on QLQ-C30 Quality-of-life scale | up to 20 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality-of-life questionaries score related to endometrial cancer | Unit on QLQ-EN-24 Quality-of-life scale | up to 20 months |
| Quality-of-life questionaries score related to cervical cancer | Unit on QLQ-Cx-24 Quality-of-life scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Blanca Gil-Ibañez, MD, PhD | Contact | 0034-646886495 | blancalabacin@hotmail.com | |
| Gregorio Lopez, MD,PhD | Contact | goyolopez2@hotmail.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37748803 | Derived | 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. |
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| up to 20 months |
| Quality-of-life questionaries score related to ovarian cancer | Unit on QLQ-Ov-28 Quality-of-life scale | up to 20 months |
| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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