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

Not Applicable

Completed

• Conditions: Breast Cancer, Early-Onset
• Interventions: Device: Mobile software for follow-up of early breast cancer

• Registration Number: NCT04980989
• Lead Sponsor: Helsinki University Central Hospital

Brief 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.

Study Timeline

• Study Start: 2015-06-15
• Primary Completion: 2021-06-15
• Study Completion: 2021-06-15
• Status Verified: 2021-07
• Study First Submitted: 2021-07-21
• Study First Submitted QC: 2021-07-21
• Last Update Submitted: 2021-07-21
• Study First Posted: 2021-07-28
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 765

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mobile software	Mobile software for follow-up of early breast cancer	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.
Telephone calls	Mobile software for follow-up of early breast cancer	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.

Primary Outcome Measures

Name	Time	Method
Patient preference for follow-up modality	At 12 months during follow-up of early breast cancer	Questionnaire of patient preference

Secondary Outcome Measures

Name	Time	Method
Quality of life during follow-up modality	At baseline, 6 months and 12 months	Quality of life questionnaires
Patient satisfaction	At 6 months and 12 months	Patient satisfaction questionnaires
Symptoms	At baseline, 6 months and 12 months	Symptom questionnaire
Use of other healthcare services	At 6 months and 12 months	Questionnaire