Clinical Trials Directory

Trials / Completed

CompletedNCT05085678

Co'Moon for Supporting Breast Cancer Patients on Adjuvant Endocrine Therapy

Development and Evaluation of a PROMs-based Interactive Programme as a Supporting Tool for Breast Cancer Patients Using Adjuvant Endocrine Therapy

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
77 (actual)
Sponsor
Universitaire Ziekenhuizen KU Leuven · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

Summary

The objective of the study is to evaluate the effect of an online tool, based on patient reported outcomes (Co'moon), on the quality of life of breast cancer patients on adjuvant endocrine therapy in the University Hospital Leuven.

Detailed description

The project aims to develop and evaluate an online programme to support patients with breast cancer on adjuvant endocrine therapy in the University Hospital Leuven. The tool "Co'moon" has been developed in the first phase of the project and secondly refine in a pilot study. In the third phase a randomised controlled study investigates the effect of Co'moon in comparison with the standard of care in the University Hospital Leuven. Hereby focussing on the improvement of self-efficacy en quality of life.

Conditions

Interventions

TypeNameDescription
DEVICECo'moon (online website to support women with AET)The tool contains three parts: 1. e-learning based on the brochure on adjuvant endocrine therapy (AET) in the University Hospital Leuven, 2. serious game where patients are confronted with scenes of their daily life and motivational guidelines to stimulate their self-management, 3. a patient-reported-outcome questionnaire (PROMs), reported in the patient medical file. The tool is designed to stimulate patients self-management of their menopausal AET-related complaints and to discuss them with their health care professionals .

Timeline

Start date
2020-12-01
Primary completion
2021-12-31
Completion
2022-12-31
First posted
2021-10-20
Last updated
2023-03-28

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT05085678. Inclusion in this directory is not an endorsement.