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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer, Quality of Life, Self Efficacy

Intervention / Treatment
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* Device: Co'moon (online website to support women with AET)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled trial with convenience sampling
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>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 | |
| Experimental: Intervention group<br>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. | Device: Co'moon (online website to support women with AET)<br>* 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 .<br>* Other names: Class 1 medical device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change in self-efficacy | patient reported impact on the side effects of AET | month 3 and 6 or 7 after the start with AET | 
| Therapy adherence | patient reported intentional or accidental forgot the medication | monthly after two months of AET; up to 3 months | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcomes | Subscales of FACT-ES combined with additional questions B5 and H18. | Monthly after two months of AET; up to 3 months | 
| 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 | 
| Time-spend on Co'moon | Logging of the time women spend on Co'moon | up to 3 months |