search
Back to results

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
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 21, 2021
    Last Updated
    July 21, 2021
    Sponsor
    Helsinki University Central Hospital
    Collaborators
    University of Helsinki, Noona Healthcare
    search

    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