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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05085678
• Other study ID #: G0F9119N
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria patients:

• Women
• Older than 18 years
• Speaking, understanding and writing Dutch fluently
• Mentally competent
• Recently underwent a operation for breast cancer (invasive or in situ)
• Takes AET for maximum two months
• Consultation planned within 4-5 month
• Home access of a computer with internet connection

Exclusion Criteria patients:

• Different treatments regimes (e.g. adjuvant trial or a combination with cycline-dependent kinase (CDK) 4/6-inhibitors)
• Metastatic disease

Inclusion Criteria health care professionals:

• Contact with patient(s) included in the trial

Exclusion Criteria health care professionals:

• Included in panels
• Member of the research team

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Quality of Life
• Self Efficacy

Intervention

Device:
• Co'moon (online website to support women with AET)
The tool contains three parts: e-learning based on the brochure on adjuvant endocrine therapy (AET) in the University Hospital Leuven, serious game where patients are confronted with scenes of their daily life and motivational guidelines to stimulate their self-management, 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 .

Locations

Country	Name	City	State
Belgium	UZ Leuven campus Gasthuisberg	Leuven	Vlaams-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in quality of Life - FACT-ES - B5 - H18	Total score of Functional Assessment of Chronic Illness Therapy system of Quality of Life questionnaires of endocrine symptoms (FACT-ES) combined with additional questions B5 and H18. A validated questionnaire with a 5-point Likert scale and a total score of 180 (high QoL).	monthly after two months of AET; up to 3 months
Primary	Change in self-efficacy	patient reported impact on the side effects of AET	month 3 and 6 or 7 after the start with AET
Primary	Therapy adherence	patient reported intentional or accidental forgot the medication	monthly after two months of AET; up to 3 months
Primary	Questionnaire on patients experience with the patient-physician relationship	patient reported their experience of the follow-up consultation in a 5 point Likert scale questionnaire	month 6 or 7 after the start with AET
Primary	Questionnaire on change in patient-relative communication over a period of +/- 3 months	patient reported a change in the communication of patients with their relatives in a 5 point Likert scale questionnaire	month 3 and 6 or 7 after the start with AET
Secondary	Patient reported outcomes	Subscales of FACT-ES combined with additional questions B5 and H18.	Monthly after two months of AET; up to 3 months
Secondary	Questionnaire on the experience of the healthcare professional regarding the summary of PRO's	the experience of healthcare professionals with the consultation with a 5 point Likert scale questionnaire (1 = strongly disagree, and 5 = strongly agree). The maximum score is 25.	month 6 or 7 after the start of AET
Secondary	Time-spend on Co'moon	Logging of the time women spend on Co'moon	up to 3 months