Clinical trial NCT05085678: Co'Moon for Supporting Breast Cancer Patients on Adjuvant Endocrine Therapy
Official title: Development and Evaluation of a PROMs-based Interactive Programme as a Supporting Tool for Breast Cancer Patients Using Adjuvant Endocrine Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Quality of Life
Self Efficacy
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2021-10-20
Enrollment: 77
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial with convenience sampling
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in quality of Life - FACT-ES - B5 - H18
timeFrame: monthly after two months of AET; up to 3 months
measure: Change in self-efficacy
timeFrame: month 3 and 6 or 7 after the start with AET
measure: Therapy adherence
timeFrame: monthly after two months of AET; up to 3 months
measure: Questionnaire on patients experience with the patient-physician relationship
timeFrame: month 6 or 7 after the start with AET
measure: Questionnaire on change in patient-relative communication over a period of +/- 3 months
timeFrame: month 3 and 6 or 7 after the start with AET
Secondary outcomes:
measure: Patient reported outcomes
timeFrame: Monthly after two months of AET; up to 3 months
measure: Questionnaire on the experience of the healthcare professional regarding the summary of PRO's
timeFrame: month 6 or 7 after the start of AET
measure: Time-spend on Co'moon
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven campus Gasthuisberg
state: Vlaams-Brabant
Study officials:
affiliation: UZ Leuven
name: Ines Nevelsteen, Phd
role: PRINCIPAL_INVESTIGATOR
References: