NCT04980989

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 765 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Breast Cancer, Early-Onset

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2015-06-15
• Primary completion: 2021-06-15
• Completion: 2021-06-15
• First posted: 2021-07-28
• Last updated: 2021-07-28