Skip to content

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04980989
Enrollment
765
Registered
2021-07-28
Start date
2015-06-15
Completion date
2021-06-15
Last updated
2021-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Early-Onset

Keywords

follow-up, mobile software, early breast cancer

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.

Interventions

DEVICEMobile 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

Sponsors

University of Helsinki
CollaboratorOTHER
Noona Healthcare
CollaboratorUNKNOWN
Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model 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. 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patient preference for follow-up modalityAt 12 months during follow-up of early breast cancerQuestionnaire of patient preference

Secondary

MeasureTime frameDescription
Quality of life during follow-up modalityAt baseline, 6 months and 12 monthsQuality of life questionnaires
Patient satisfactionAt 6 months and 12 monthsPatient satisfaction questionnaires
SymptomsAt baseline, 6 months and 12 monthsSymptom questionnaire
Use of other healthcare servicesAt 6 months and 12 monthsQuestionnaire

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026