Telemedicine-guided Patients Reported Outcome Measures (PROMs): Side Effects Screening and Early Intervention to Impact in Quality of Life of Gynaecological Cancer Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Quality of Life
- Sponsor
- Hospital Universitario 12 de Octubre
- Enrollment
- 168
- Primary Endpoint
- Quality-of-life questionaries score
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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
Investigators
Blanca Gil Ibañez
Principal Investigador, MD, PhD
Hospital Universitario 12 de Octubre
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.
Outcomes
Primary Outcomes
Quality-of-life questionaries score
Time Frame: up to 20 months
Unit on QLQ-C30 Quality-of-life scale
Secondary Outcomes
- Quality-of-life questionaries score related to cervical cancer(up to 20 months)
- Quality-of-life questionaries score related to ovarian cancer(up to 20 months)
- Quality-of-life questionaries score related to endometrial cancer(up to 20 months)