跳至主要内容
临床试验/NCT05918770
NCT05918770尚未招募不适用

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 个研究点目标入组 168 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
168
主要终点
Quality-of-life questionaries score

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged ≥18 diagnosed with ovarian, tubal and primary peritoneal, cervical and endometrial cancer who are candidates for surgery during the study period.

排除标准

  • Patients unable to complete by themselves the screening questionnaires included.

结局指标

主要结局

Quality-of-life questionaries score

时间窗: up to 20 months

Unit on QLQ-C30 Quality-of-life scale

次要结局

  • 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)

研究者

发起方
Hospital Universitario 12 de Octubre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Blanca Gil Ibañez

Principal Investigador, MD, PhD

Hospital Universitario 12 de Octubre

相似试验