Breast Cancer, Early-OnsetNCT04980989
Follow-up of Early Breast Cancer (BC) Patients by Telephone or Mobile Software
A study testing Mobile software for follow-up of early breast cancer in people with Breast Cancer, Early-Onset, run by Helsinki University Central Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Early-Onset
- What is being tested?
- Mobile software for follow-up of early breast cancer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 765 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2015to 15 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with early breast cancer after primary treatment including also radiotherapy (the patients were randomized at the final visit of radiotherapy)
Who cannot join
- not able to use a computer
- another malignancy
About this study
Official title: A Prospective Randomized Trial of Interactive Telemonitoring in the Follow-up of Patients Treated for Breast Cancer
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.
Read the 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.
- Conditions
- Breast Cancer, Early-Onset
- Being tested
- Mobile software for follow-up of early breast cancer
- Keywords
- follow-up, mobile software, early breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile software for follow-up of early breast cancerDevice
Also called Noona mobile software
The patients were randomized to use mobile software or telephone calls as the follow-up modality for early breast cancer
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Mobile software for follow-up of early breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient preference for follow-up modality
Questionnaire of patient preference
Measured: At 12 months during follow-up of early breast cancer
Secondary outcomes (4)
Quality of life during follow-up modality
Quality of life questionnaires
Measured: At baseline, 6 months and 12 months
Patient satisfaction
Patient satisfaction questionnaires
Measured: At 6 months and 12 months
Symptoms
Symptom questionnaire
Measured: At baseline, 6 months and 12 months
Use of other healthcare services
Questionnaire
Measured: At 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start15 Jun 2015
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer, Early-OnsetStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 765 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki, Noona Healthcare
- Responsible party
- Principal investigator, Johanna Mattson, Helsinki University Central Hospital
- Investigators
- Johanna Mattson, MD, PhD, Principal investigator, Helsinki University Central HospitalCarl Blomqvist, Professor, Study chair, Helsinki University Central HospitalJohanna Mattson, MD, PhD, Study director, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980989
- Sponsor's protocol ID
- 112/13/03/02/2015
- Status last verified
- Jul 2021
- First submitted
- 21 Jul 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37190970
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Interactive Telemonitoring in the Follow-up of Patients Treated for Breast Cancer
- ClinicalTrials.gov ID
- NCT04980989
- Acronym / sponsor ID
- 112/13/03/02/2015
- Conditions
- Breast Cancer, Early-Onset
- Keywords
- follow-up, mobile software, early breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 765 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki, Noona Healthcare
- Study start
- 15 Jun 2015 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mobile software | Experimental | Device: Mobile software for follow-up of early breast cancerPatient 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. |
| Telephone calls | Active comparator | Device: Mobile software for follow-up of early breast cancerPatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with early breast cancer after primary treatment including also radiotherapy (the patients were randomized at the final visit of radiotherapy)
Key exclusion criteria (2 listed)
- not able to use a computer
- another malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile software for follow-up of early breast cancerAlso: Noona mobile softwareThe patients were randomized to use mobile software or telephone calls as the follow-up modality for early breast cancer | Device | Mobile software, Telephone calls |
Primary outcome
Patient preference for follow-up modality
Time frame: At 12 months during follow-up of early breast cancer
Questionnaire of patient preference
4 secondary outcomes
Quality of life during follow-up modality
Time frame: At baseline, 6 months and 12 months
Patient satisfaction
Time frame: At 6 months and 12 months
Symptoms
Time frame: At baseline, 6 months and 12 months
Use of other healthcare services
Time frame: At 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Derived from this study: PubMed 37190970Mattson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johanna Mattson, MD, PhD principal investigator
Helsinki University Central Hospital
Carl Blomqvist, Professor study chair
Helsinki University Central Hospital
Johanna Mattson, MD, PhD study director
Helsinki University Central Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Mobile software for follow-up of early breast cancer in people with Breast Cancer, Early-Onset, run by Helsinki University Central Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient preference for follow-up modality (time frame: At 12 months during follow-up of early breast cancer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04980989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.