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

NCT04980989 | Completed

• 1 other identifier: 112/13/03/02/2015
• Study Type: interventional
• Target: 765
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer, Early-Onset

Keywords

follow-up, mobile software, early breast cancer

Outcome Measures

Primary Outcomes (1)

• Patient preference for follow-up modality

  Questionnaire of patient preference

  At 12 months during follow-up of early breast cancer

Secondary Outcomes (4)

• Quality of life during follow-up modality

  At baseline, 6 months and 12 months

• Patient satisfaction

  At 6 months and 12 months

• Symptoms

  At baseline, 6 months and 12 months

• Use of other healthcare services

  At 6 months and 12 months

Study Arms (2)

Mobile software

EXPERIMENTAL

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.

Device: Mobile software for follow-up of early breast cancer

Telephone calls

ACTIVE COMPARATOR

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.

Device: Mobile software for follow-up of early breast cancer

Interventions

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

Also known as: Noona mobile software

Mobile software; Telephone calls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with early breast cancer after primary treatment including also radiotherapy (the patients were randomized at the final visit of radiotherapy)

You may not qualify if:

• not able to use a computer
• another malignancy

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• University of Helsinki: collaborator
• Noona Healthcare: collaborator

Related Publications (1)

• Mattson J, Peltola M, Poikonen-Saksela P, Hermanson T, Their J, Farkkila N, Roine R, Blomqvist C. Digital solution in the follow-up of early breast cancer a randomized study. Acta Oncol. 2023 May;62(5):513-521. doi: 10.1080/0284186X.2023.2212409. Epub 2023 May 16.

  PMID: 37190970 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Johanna Mattson, MD, PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

• Carl Blomqvist, Professor

  Helsinki University Central Hospital

  STUDY CHAIR

• Johanna Mattson, MD, PhD

  Helsinki University Central Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician-in-Chief

Model Details: 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.

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: July 28, 2021
• Study Start: June 15, 2015
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share