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

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Breast Cancer, Early-Onset

Treatments: Device: Mobile software for follow-up of early breast cancer

Study type: Interventional

Funder types: Other

Identifiers

NCT04980989

112/13/03/02/2015

Details and patient eligibility

About

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.

Full 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.

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.

Enrollment: 765 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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765 participants in 2 patient groups

Mobile software

Experimental group

Description:

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.

Treatment:

Device: Mobile software for follow-up of early breast cancer

Telephone calls

Active Comparator group

Description:

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.

Treatment:

Device: Mobile software for follow-up of early breast cancer