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

June 23, 2023 updated by: Blanca Gil Ibañez, Hospital Universitario 12 de Octubre

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality-of-life questionaries score
Time Frame: up to 20 months
Unit on QLQ-C30 Quality-of-life scale
up to 20 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality-of-life questionaries score related to endometrial cancer
Time Frame: up to 20 months
Unit on QLQ-EN-24 Quality-of-life scale
up to 20 months
Quality-of-life questionaries score related to cervical cancer
Time Frame: up to 20 months
Unit on QLQ-Cx-24 Quality-of-life scale
up to 20 months
Quality-of-life questionaries score related to ovarian cancer
Time Frame: up to 20 months
Unit on QLQ-Ov-28 Quality-of-life scale
up to 20 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario 12 de Octubre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

June 5, 2023

First Submitted That Met QC Criteria

June 23, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 23, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nº CEIm: 23/157

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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