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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHospital Universitario 12 de Octubre

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women aged ≥18 diagnosed with ovarian, tubal and primary peritoneal, cervical and endometrial cancer who are candidates for surgery during the study period.

Disqualifiers

Patients unable to complete by themselves the screening questionnaires included.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

168 Participants
are divided into 2 treatment groups
Group A: experimental groupExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Quality-of-life questionaries score

Unit on QLQ-C30 Quality-of-life scale

Time frame
up to 20 months

Secondary outcomes

1

Quality-of-life questionaries score related to endometrial cancer

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

Time frame
up to 20 months
2

Quality-of-life questionaries score related to cervical cancer

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

Time frame
up to 20 months
3

Quality-of-life questionaries score related to ovarian cancer

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

Time frame
up to 20 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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