Follow-up of Early Breast Cancer (BC) Patients by Telephone or Mobile Software

Study Overview
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Brief Summary
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Patients with early breast cancer were randomized at the final visit of adjuvant radiotherapy to surveillance by phone calls or by mobile Noona software. After six months the groups were crossed over to the other arm. At 12 months the patients were asked their preference which was the primary end-point. At baseline, 6 months and 12 months the patients answered the other questionnaires.

Detailed Description
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Patients with early breast cancer were randomized at the final visit of adjuvant radiotherapy to surveillance by phone calls or by mobile Noona software. After six months the groups were crossed over to the other arm. The primary end point was to find out patient preference for the modality of surveillance. Secondary endpoints were patient satisfaction, symptoms, quality of life and cost of follow-up during surveillance modalities. At 12 months the patients were asked their preference for the follow-up modality of early breast cancer. At baseline, 6 months and 12 months the patients answered the other questionnaires on quality of life, symptoms, patient satisfaction and use of other health-care services. Information on the cost of follow-up was gathered from the hospital and other registries.

Official Title
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A Prospective Randomized Trial of Interactive Telemonitoring in the Follow-up of Patients Treated for Breast Cancer

Conditions
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Breast Cancer, Early-Onset

Intervention / Treatment
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* Device: Mobile software for follow-up of early breast cancer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with early breast cancer after primary treatment including also radiotherapy (the patients were randomized at the final visit of radiotherapy) Exclusion Criteria: not able to use a computer another malignancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Patients with early breast cancer were randomized at the final visit of adjuvant radiotherapy to surveillance by phone calls or by mobile Noona software. After six months the groups were crossed over to the other arm. At 12 months the patients were asked their preference. At baseline, 6 months and 12 months the patients answered the other questionnaires on patient satisfaction, quality of life, symptoms and use of other healthcare services.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile software<br>Patient with early breast cancer were followed-up by mobile software for the first six months. At six months they crossed-over to be followed-up by telephone calls for the next six months. | Device: Mobile software for follow-up of early breast cancer<br>* The patients were randomized to use mobile software or telephone calls as the follow-up modality for early breast cancer<br>* Other names: Noona mobile software;|
| Active Comparator: Telephone calls<br>Patient with early breast cancer were followed-up by telephone calls for the first six months. At six months they crossed-over to be followed-up by mobile software for the next six months. | Device: Mobile software for follow-up of early breast cancer<br>* The patients were randomized to use mobile software or telephone calls as the follow-up modality for early breast cancer<br>* Other names: Noona mobile software;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient preference for follow-up modality | Questionnaire of patient preference | At 12 months during follow-up of early breast cancer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life during follow-up modality | Quality of life questionnaires | At baseline, 6 months and 12 months | 
| Patient satisfaction | Patient satisfaction questionnaires | At 6 months and 12 months | 
| Symptoms | Symptom questionnaire | At baseline, 6 months and 12 months | 
| Use of other healthcare services | Questionnaire | At 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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follow-up, mobile software, early breast cancer