Follow-up of Early Breast Cancer (BC) Patients by Telephone or Mobile Software
Primary Purpose
Breast Cancer, Early-Onset
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mobile software for follow-up of early breast cancer
Sponsored by
About this trial
This is an interventional health services research trial for Breast Cancer, Early-Onset focused on measuring follow-up, mobile software, early breast cancer
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mobile software
Telephone calls
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Patient preference for follow-up modality
Questionnaire of patient preference
Secondary Outcome Measures
Quality of life during follow-up modality
Quality of life questionnaires
Patient satisfaction
Patient satisfaction questionnaires
Symptoms
Symptom questionnaire
Use of other healthcare services
Questionnaire
Full Information
NCT ID
NCT04980989
First Posted
July 21, 2021
Last Updated
July 21, 2021
Sponsor
Helsinki University Central Hospital
Collaborators
University of Helsinki, Noona Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT04980989
Brief Title
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
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 15, 2015 (Actual)
Primary Completion Date
June 15, 2021 (Actual)
Study Completion Date
June 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
Collaborators
University of Helsinki, Noona Healthcare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Early-Onset
Keywords
follow-up, mobile software, early breast cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
765 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobile software
Arm Type
Experimental
Arm Description
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.
Arm Title
Telephone calls
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Mobile software for follow-up of early breast cancer
Other Intervention Name(s)
Noona mobile software
Intervention Description
The patients were randomized to use mobile software or telephone calls as the follow-up modality for early breast cancer
Primary Outcome Measure Information:
Title
Patient preference for follow-up modality
Description
Questionnaire of patient preference
Time Frame
At 12 months during follow-up of early breast cancer
Secondary Outcome Measure Information:
Title
Quality of life during follow-up modality
Description
Quality of life questionnaires
Time Frame
At baseline, 6 months and 12 months
Title
Patient satisfaction
Description
Patient satisfaction questionnaires
Time Frame
At 6 months and 12 months
Title
Symptoms
Description
Symptom questionnaire
Time Frame
At baseline, 6 months and 12 months
Title
Use of other healthcare services
Description
Questionnaire
Time Frame
At 6 months and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johanna Mattson, MD, PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carl Blomqvist, Professor
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Johanna Mattson, MD, PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Follow-up of Early Breast Cancer (BC) Patients by Telephone or Mobile Software
We'll reach out to this number within 24 hrs