Side Effects Screening and Early Intervention to Impact in Quality of Life of Gynaecological Cancer Patients

Quality of Life Clinical Trial

— HALIS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05918770
• Other study ID #: Nº CEIm: 23/157
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: September 2026

Study information

• Verified date: June 2023
• Source: Hospital Universitario 12 de Octubre
• Contact: Blanca Gil-Ibañez, MD, PhD
• Phone: 0034-646886495
• Email: blancalabacin[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 168
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gynaecological Cancer
• Lymphedema
• Quality of Life
• Sexual Dysfunction

Intervention

Diagnostic Test:
• systematic 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario 12 de Octubre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality-of-life questionaries score	Unit on QLQ-C30 Quality-of-life scale	up to 20 months
Secondary	Quality-of-life questionaries score related to endometrial cancer	Unit on QLQ-EN-24 Quality-of-life scale	up to 20 months
Secondary	Quality-of-life questionaries score related to cervical cancer	Unit on QLQ-Cx-24 Quality-of-life scale	up to 20 months
Secondary	Quality-of-life questionaries score related to ovarian cancer	Unit on QLQ-Ov-28 Quality-of-life scale	up to 20 months