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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

765 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-15

Study Completion Date

2021-06-15

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.

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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.

Conditions

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Breast Cancer, Early-Onset

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Mobile software

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.

Group Type EXPERIMENTAL

Mobile software for follow-up of early breast cancer

Intervention Type DEVICE

The patients were randomized to use mobile software or telephone calls as the follow-up modality for early breast cancer

Telephone calls

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.

Group Type ACTIVE_COMPARATOR

Mobile software for follow-up of early breast cancer

Intervention Type DEVICE

The patients were randomized to use mobile software or telephone calls as the follow-up modality for early breast cancer

Interventions

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Mobile software for follow-up of early breast cancer

The patients were randomized to use mobile software or telephone calls as the follow-up modality for early breast cancer

Intervention Type DEVICE

Other Intervention Names

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Noona mobile software

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)