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

Primary Purpose

Quality of Life, Gynaecological Cancer, Lymphedema, Lower Limb

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
systematic screening and early treatment
Sponsored by
Hospital Universitario 12 de Octubre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Quality of Life focused on measuring quality of life, Gynaecological cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    experimental group

    control group

    Arm Description

    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)

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

    Outcomes

    Primary Outcome Measures

    Quality-of-life questionaries score
    Unit on QLQ-C30 Quality-of-life scale

    Secondary Outcome Measures

    Quality-of-life questionaries score related to endometrial cancer
    Unit on QLQ-EN-24 Quality-of-life scale
    Quality-of-life questionaries score related to cervical cancer
    Unit on QLQ-Cx-24 Quality-of-life scale
    Quality-of-life questionaries score related to ovarian cancer
    Unit on QLQ-Ov-28 Quality-of-life scale

    Full Information

    First Posted
    June 5, 2023
    Last Updated
    June 23, 2023
    Sponsor
    Hospital Universitario 12 de Octubre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05918770
    Brief Title
    Side Effects Screening and Early Intervention to Impact in Quality of Life of Gynaecological Cancer Patients
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    September 2026 (Anticipated)
    Study Completion Date
    September 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Universitario 12 de Octubre

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Quality of Life, Gynaecological Cancer, Lymphedema, Lower Limb, Sexual Dysfunction
    Keywords
    quality of life, Gynaecological cancer

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    168 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    experimental group
    Arm Type
    Experimental
    Arm Description
    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)
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    will follow the standard usual care guidelines at the centre where patients will be opportunistically referred to specialised care
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    systematic screening and early treatment
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Quality-of-life questionaries score
    Description
    Unit on QLQ-C30 Quality-of-life scale
    Time Frame
    up to 20 months
    Secondary Outcome Measure Information:
    Title
    Quality-of-life questionaries score related to endometrial cancer
    Description
    Unit on QLQ-EN-24 Quality-of-life scale
    Time Frame
    up to 20 months
    Title
    Quality-of-life questionaries score related to cervical cancer
    Description
    Unit on QLQ-Cx-24 Quality-of-life scale
    Time Frame
    up to 20 months
    Title
    Quality-of-life questionaries score related to ovarian cancer
    Description
    Unit on QLQ-Ov-28 Quality-of-life scale
    Time Frame
    up to 20 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Blanca Gil-Ibañez, MD, PhD
    Phone
    0034-646886495
    Email
    blancalabacin@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gregorio Lopez, MD,PhD
    Email
    goyolopez2@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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