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

Not Applicable

Completed

• Conditions: Self Efficacy; Breast Cancer; Quality of Life
• Interventions: Device: Co'moon (online website to support women with AET)

• Registration Number: NCT05085678
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief 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.

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-08-13
• Study First Submitted QC: 2021-10-07
• Study First Posted: 2021-10-20
• Primary Completion: 2021-12-31
• Status Verified: 2022-05
• Study Completion: 2022-12-31
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 77

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Co'moon (online website to support women with AET)	Standard care with the access of to the online tool Co'moon and a monthly questionnaire on patient reported outcomes. The outcome of the questionnaires are summarized for the physician to discuss during the follow-up consultation.

Primary Outcome Measures

Name	Time	Method
Change in quality of Life - FACT-ES - B5 - H18	monthly after two months of AET; up to 3 months	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).
Change in self-efficacy	month 3 and 6 or 7 after the start with AET	patient reported impact on the side effects of AET
Therapy adherence	monthly after two months of AET; up to 3 months	patient reported intentional or accidental forgot the medication
Questionnaire on patients experience with the patient-physician relationship	month 6 or 7 after the start with AET	patient reported their experience of the follow-up consultation in a 5 point Likert scale questionnaire
Questionnaire on change in patient-relative communication over a period of +/- 3 months	month 3 and 6 or 7 after the start with AET	patient reported a change in the communication of patients with their relatives in a 5 point Likert scale questionnaire

Secondary Outcome Measures

Name	Time	Method
Patient reported outcomes	Monthly after two months of AET; up to 3 months	Subscales of FACT-ES combined with additional questions B5 and H18.
Questionnaire on the experience of the healthcare professional regarding the summary of PRO's	month 6 or 7 after the start of AET	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.
Time-spend on Co'moon	up to 3 months	Logging of the time women spend on Co'moon

Trial Locations

Locations (1)

UZ Leuven campus Gasthuisberg; 🇧🇪 Leuven, Vlaams-Brabant, Belgium