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Clinical Trials/NCT05918770
NCT05918770
Not yet recruiting
Not Applicable

Telemedicine-guided Patients Reported Outcome Measures (PROMs): Side Effects Screening and Early Intervention to Impact in Quality of Life of Gynaecological Cancer Patients

Hospital Universitario 12 de Octubre0 sites168 target enrollmentSeptember 2023

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

Registry
clinicaltrials.gov
Start Date
September 2023
End Date
September 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Hospital Universitario 12 de Octubre
Responsible Party
Principal Investigator
Principal Investigator

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)

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