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| Name | Class |
|---|---|
| KU Leuven | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Standard of care:
and a monthly questionnaire on the patient reported outcomes | |
| Intervention group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Co'moon (online website to support women with AET) | Device | The tool contains three parts:
The tool is designed to stimulate patients self-management of their menopausal AET-related complaints and to discuss them with their health care professionals . |
| 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 |
| 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 |
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Inclusion Criteria patients:
Exclusion Criteria patients:
Inclusion Criteria health care professionals:
Exclusion Criteria health care professionals:
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| Name | Affiliation | Role |
|---|---|---|
| Ines Nevelsteen, Phd | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven campus Gasthuisberg | Leuven | Vlaams-Brabant | 3000 | Belgium |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Randomised controlled trial with convenience sampling
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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 |
| D017437 |
| Skin and Connective Tissue Diseases |