Clinical trial NCT04980989: Follow-up of Early Breast Cancer (BC) Patients by Telephone or Mobile Software
Official title: A Prospective Randomized Trial of Interactive Telemonitoring in the Follow-up of Patients Treated for Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer, Early-Onset
Keywords: follow-up, mobile software, early breast cancer
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Helsinki
name: Noona Healthcare
First posted: 2021-07-28
Enrollment: 765
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient preference for follow-up modality
timeFrame: At 12 months during follow-up of early breast cancer
Secondary outcomes:
measure: Quality of life during follow-up modality
timeFrame: At baseline, 6 months and 12 months
measure: Patient satisfaction
timeFrame: At 6 months and 12 months
measure: Symptoms
timeFrame: At baseline, 6 months and 12 months
measure: Use of other healthcare services
timeFrame: At 6 months and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Helsinki University Central Hospital
name: Johanna Mattson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital
name: Carl Blomqvist, Professor
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Johanna Mattson, MD, PhD
role: STUDY_DIRECTOR
References: