Breast Cancer, Quality of Life, Self Efficacy
Conditions
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.
Interventions
DEVICECo'moon (online website to support women with AET)
The tool contains three parts: 1. e-learning based on the brochure on adjuvant endocrine therapy (AET) in the University Hospital Leuven, 2. serious game where patients are confronted with scenes of their daily life and motivational guidelines to stimulate their self-management, 3. 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 .
Sponsors
KU Leuven
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomised controlled trial with convenience sampling
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Patient reported outcomes | Monthly after two months of AET; up to 3 months | Subscales of FACT-ES combined with additional questions B5 and H18. |
Countries
Belgium
Outcome results
None listed