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

Sponsor

Hospital Universitario 12 de Octubre (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05918770

Collaborator

(none)

168

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Quality of Life Gynaecological Cancer Lymphedema, Lower Limb Sexual Dysfunction	Diagnostic Test: systematic screening and early treatment	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

168 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2026

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: experimental group 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)	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
No Intervention: control group will follow the standard usual care guidelines at the centre where patients will be opportunistically referred to specialised care

Arm

Intervention/Treatment

Experimental: experimental group

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)

Diagnostic Test: systematic screening and early treatment

No Intervention: control group

will follow the standard usual care guidelines at the centre where patients will be opportunistically referred to specialised care

Outcome Measures

Primary Outcome Measures

Quality-of-life questionaries score [up to 20 months]
Unit on QLQ-C30 Quality-of-life scale

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hospital Universitario 12 de Octubre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Blanca Gil Ibañez, Principal Investigador, MD, PhD, Hospital Universitario 12 de Octubre

ClinicalTrials.gov Identifier:

NCT05918770

Other Study ID Numbers:

Nº CEIm: 23/157

First Posted:

Jun 26, 2023

Last Update Posted:

Jun 26, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Blanca Gil Ibañez, Principal Investigador, MD, PhD, Hospital Universitario 12 de Octubre

quality of life

Gynaecological cancer

Additional relevant MeSH terms:

Lymphedema

Study Results

No Results Posted as of Jun 26, 2023