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

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Self Efficacy; Breast Cancer; Quality of Life

Treatments: Device: Co'moon (online website to support women with AET)

Study type: Interventional

Funder types: Other

Identifiers

NCT05085678

G0F9119N

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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77 participants in 2 patient groups

Control group

No Intervention group

Description:

Standard of care: * a short overview of the physician on adjuvant endocrine therapy * a brochure on adjuvant endocrine therapy * a voluntary group session on adjuvant endocrine therapy and a monthly questionnaire on the patient reported outcomes

Intervention group

Experimental group

Description:

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.

Treatment:

Device: Co'moon (online website to support women with AET)