Side Effects Screening and Early Intervention to Impact in Quality of Life of Gynaecological Cancer Patients
HALIS
Telemedicine-guided Patients Reported Outcome Measures (PROMs): Side Effects Screening and Early Intervention to Impact in Quality of Life of Gynaecological Cancer Patients
1 other identifier
interventional
168
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable quality-of-life
Started Sep 2023
Longer than P75 for not_applicable quality-of-life
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2023
CompletedFirst Posted
Study publicly available on registry
June 26, 2023
CompletedStudy Start
First participant enrolled
September 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
June 26, 2023
June 1, 2023
3 years
June 5, 2023
June 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality-of-life questionaries score
Unit on QLQ-C30 Quality-of-life scale
up to 20 months
Secondary Outcomes (3)
Quality-of-life questionaries score related to endometrial cancer
up to 20 months
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
Study Arms (2)
experimental group
EXPERIMENTALin 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)
control group
NO INTERVENTIONwill follow the standard usual care guidelines at the centre where patients will be opportunistically referred to specialised care
Interventions
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
Eligibility Criteria
You may qualify if:
- Women aged ≥18 diagnosed with ovarian, tubal and primary peritoneal, cervical and endometrial cancer who are candidates for surgery during the study period.
You may not qualify if:
- Patients unable to complete by themselves the screening questionnaires included.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Gil-Ibanez B, Tejerizo-Garcia A, Oliver MR, Madariaga A, Maiz Jimenez M, Gil Garcia A, Lopez-Gonzalez G. Side effects screening and early intervention to impact in quality of life of patients with gynecological cancers (HALIS study). Int J Gynecol Cancer. 2023 Oct 2;33(10):1645-1648. doi: 10.1136/ijgc-2023-004802.
PMID: 37748803DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigador, MD, PhD
Study Record Dates
First Submitted
June 5, 2023
First Posted
June 26, 2023
Study Start
September 1, 2023
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
June 26, 2023
Record last verified: 2023-06