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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer, Early-Onset
• Intervention / Treatment: Device: Mobile software for follow-up of early breast cancer

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 Type: Interventional
• Enrollment (Actual): 765
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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; Other Names: Noona mobile software
ACTIVE_COMPARATOR: 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.	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; Other Names: Noona mobile software

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: University of Helsinki; Noona Healthcare
• Investigators: Principal Investigator: Johanna Mattson, MD, PhD, Helsinki University Central Hospital; Study Chair: Carl Blomqvist, Professor, Helsinki University Central Hospital; Study Director: Johanna Mattson, MD, PhD, Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2015
• Primary Completion (ACTUAL): June 15, 2021
• Study Completion (ACTUAL): June 15, 2021

Study Registration Dates

• First Submitted: July 21, 2021
• First Submitted That Met QC Criteria: July 21, 2021
• First Posted (ACTUAL): July 28, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: follow-up, mobile software, early breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 112/13/03/02/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No