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NCT Number: NCT05918770

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

systematic screening and early treatment

Diagnostic Test

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 outcomes

  1. Quality-of-life questionaries score

    Time frame: up to 20 months

    Unit on QLQ-C30 Quality-of-life scale

Secondary outcomes

  1. Quality-of-life questionaries score related to endometrial cancer

    Time frame: up to 20 months

    Unit on QLQ-EN-24 Quality-of-life scale

  2. Quality-of-life questionaries score related to cervical cancer

    Time frame: up to 20 months

    Unit on QLQ-Cx-24 Quality-of-life scale

  3. Quality-of-life questionaries score related to ovarian cancer

    Time frame: up to 20 months

    Unit on QLQ-Ov-28 Quality-of-life scale

Study contacts

Contact information is provided by the study sponsor or research team.

Blanca Gil-Ibañez, MD, PhD

CONTACT

[email protected]

0034-646886495

Gregorio Lopez, MD,PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Hospital Universitario 12 de Octubre

Other

Registry information

Official study title

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

Acronym: HALIS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 26, 2023
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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