Gynaecological Cancer, Lymphedema, Lower Limb, Quality of Life, Sexual Dysfunction
Conditions
Keywords
quality of life, Gynaecological cancer
Brief summary
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_TESTsystematic 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
Sponsors
Hospital Universitario 12 de Octubre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality-of-life questionaries score | up to 20 months | Unit on QLQ-C30 Quality-of-life scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality-of-life questionaries score related to endometrial cancer | up to 20 months | Unit on QLQ-EN-24 Quality-of-life scale |
| Quality-of-life questionaries score related to cervical cancer | up to 20 months | Unit on QLQ-Cx-24 Quality-of-life scale |
| Quality-of-life questionaries score related to ovarian cancer | up to 20 months | Unit on QLQ-Ov-28 Quality-of-life scale |
Contacts
Primary ContactBlanca Gil-Ibañez, MD, PhD
Backup ContactGregorio Lopez, MD,PhD
Outcome results
None listed