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OpenTrials
Completed

NCT Number: NCT04980989

Follow-up of Early Breast Cancer (BC) Patients by Telephone or Mobile Software

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.

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Key information

Conditions

Breast Cancer, Early-Onset Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile software for follow-up of early breast cancer

Device

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

Primary outcomes

  1. Patient preference for follow-up modality

    Time frame: At 12 months during follow-up of early breast cancer

    Questionnaire of patient preference

Secondary outcomes

  1. Quality of life during follow-up modality

    Time frame: At baseline, 6 months and 12 months

    Quality of life questionnaires

  2. Patient satisfaction

    Time frame: At 6 months and 12 months

    Patient satisfaction questionnaires

  3. Symptoms

    Time frame: At baseline, 6 months and 12 months

    Symptom questionnaire

  4. Use of other healthcare services

    Time frame: At 6 months and 12 months

    Questionnaire

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Noona Healthcare
  • University of Helsinki

Registry information

Official study title

A Prospective Randomized Trial of Interactive Telemonitoring in the Follow-up of Patients Treated for Breast Cancer

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Jul 28, 2021
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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