Breast CancerPhONEMENCT02479607
Effects of an ICT-platform for Assessment and Management of Patient-reported Symptoms During Treatment for Breast Cancer
A study testing Smartphone or tablet in people with Breast Cancer, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate the effects of an interactive Information and Communication Technologies (ICT) -platform for use in a smartphone or tablet in patients treated with neoadjuvant chemotherapy for breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Smartphone or tablet
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 30 Jun 2015to Oct 2017
- 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
- The diagnosis of breast cancer
- Patients who will receive neoadjuvant chemotherapy
- Literacy in the Swedish language
Who cannot join
- Patients who need an interpreter at the doctor's visit
- Patients who have a known severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PhONEME - ParticipatOn Ehealth MobilE. Effects of an Interactive ICT-platform for Assessment and Management of Symptoms in Patients Treated for Breast Cancer.
The purpose of this study is to evaluate the effects of an interactive Information and Communication Technologies (ICT) -platform for use in a smartphone or tablet in patients treated with neoadjuvant chemotherapy for breast cancer. The hypothesis is that clinical management will be improved and costs reduced and safe and participatory care promoted, when patients report symptoms in an application which provides self-care advice and instant access to professionals.
- Conditions
- Breast Cancer
- Being tested
- Smartphone or tablet
- Keywords
- Breast Cancer, Cytostatic Agents, Nursing, Health Literacy, Quality of Life, Oncology Nursing, Self Care, Symptom Management, Participatory Care, Person-centered Care, Information and Communication Technology, Patient-reported symptoms, Mobile device
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone or tabletDevice
Also called Intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Use of an application for a smartphone or tablet for daily reporting symptoms and access to self-care advice and health care professionals in real time in combination with standard care according to the clinic´s routines Receives: Device: Smartphone or tablet |
| Control group | No intervention | Standard care according to the clinic's routines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire Scale for Functional Health Literacy (S-FHL-Swedish version)
To evaluate self-reported data in terms of understanding health
Measured: Up to 3 months after completion of neoadjuvant chemotherapy treatment
Questionnaire Scale for Communicative and Critical Health Literacy (S-C & C HL - Swedish version)
To evaluate self-reported data in terms of communicating health
Measured: Up to 3 months after completion of neoadjuvant chemotherapy treatment
Questionnaire Individualized Care Scale (ICS)
To evaluate self-reported data in terms of individualized care
Measured: Up to 3 months after completion of neoadjuvant chemotherapy treatment
Questionnaire Sense of Coherence Scale (KASAM)
To evaluate self-reported data in terms of Sense of Coherence
Measured: Up to 3 months after completion of neoadjuvant chemotherapy treatment
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30)
To evaluate self-reported data in terms of health related quality of life
Measured: Up to 3 months after completion of neoadjuvant chemotherapy treatment
Questionnaire Memorial Symptom Assessment Scale (MSAS)
To evaluate self-reported data in terms of symptom prevalence, characteristics and distress
Measured: Up to 3 months after completion of neoadjuvant chemotherapy treatment
Secondary outcomes (1)
Health care costs
Measured: Up to 3 months after completion of neoadjuvant chemotherapy treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study start30 Jun 2015
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Ann Langius-Eklöf, Karolinska Institutet
- Investigators
- Ann Langius-Eklöf, RN, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479607
- Sponsor's protocol ID
- PhONEME Breast
- Acronym
- PhONEME
- Status last verified
- Aug 2018
- First submitted
- 12 Jun 2015
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Crafoord MT, Fjell M, Gustavell T. Exploring Patients' Care Needs in Digital Free-Text Messages During Cancer Treatment: Qualitative Analysis Guided by the Fundamentals of Care Framework. J Adv Nurs. 2026 Oct 14. doi: 10.1111/jan.70781. Online ahead of print.
PubMed 42872750Crafoord MT, Ekstrand J, Sundberg K, Nilsson MI, Fjell M, Langius-Eklof A. Mobile Electronic Patient-Reported Outcomes and Interactive Support During Breast and Prostate Cancer Treatment: Health Economic Evaluation From Two Randomized Controlled Trials. JMIR Cancer. 2025 Mar 11;11:e53539. doi: 10.2196/53539.
PubMed 40067346Langius-Eklof A, Crafoord MT, Christiansen M, Fjell M, Sundberg K. Effects of an interactive mHealth innovation for early detection of patient-reported symptom distress with focus on participatory care: protocol for a study based on prospective, randomised, controlled trials in patients with prostate and breast cancer. BMC Cancer. 2017 Jul 4;17(1):466. doi: 10.1186/s12885-017-3450-y.
PubMed 28676102
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PhONEME - ParticipatOn Ehealth MobilE. Effects of an Interactive ICT-platform for Assessment and Management of Symptoms in Patients Treated for Breast Cancer.
- ClinicalTrials.gov ID
- NCT02479607
- Acronym / sponsor ID
- PhONEME / PhONEME Breast
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Cytostatic Agents, Nursing, Health Literacy, Quality of Life, Oncology Nursing, Self Care, Symptom Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- 30 Jun 2015 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 24 Jun 2015 (estimated)
- 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.
The purpose of this study is to evaluate the effects of an interactive Information and Communication Technologies (ICT) -platform for use in a smartphone or tablet in patients treated with neoadjuvant chemotherapy for breast cancer. The hypothesis is that clinical management will be improved and costs reduced and safe and participatory care promoted, when patients report symptoms in an application which provides self-care advice and instant access to professionals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Smartphone or tabletUse of an application for a smartphone or tablet for daily reporting symptoms and access to self-care advice and health care professionals in real time in combination with standard care according to the clinic´s routines |
| Control group | No intervention | –Standard care according to the clinic's routines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The diagnosis of breast cancer
- Patients who will receive neoadjuvant chemotherapy
- Literacy in the Swedish language
Key exclusion criteria (2 listed)
- Patients who need an interpreter at the doctor's visit
- Patients who have a known severe cognitive impairment
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 |
|---|---|---|
| Smartphone or tabletAlso: Intervention | Device | Intervention group |
Primary outcome
Questionnaire Scale for Functional Health Literacy (S-FHL-Swedish version)
Time frame: Up to 3 months after completion of neoadjuvant chemotherapy treatment
To evaluate self-reported data in terms of understanding health
Questionnaire Scale for Communicative and Critical Health Literacy (S-C & C HL - Swedish version)
Time frame: Up to 3 months after completion of neoadjuvant chemotherapy treatment
To evaluate self-reported data in terms of communicating health
Questionnaire Individualized Care Scale (ICS)
Time frame: Up to 3 months after completion of neoadjuvant chemotherapy treatment
To evaluate self-reported data in terms of individualized care
Questionnaire Sense of Coherence Scale (KASAM)
Time frame: Up to 3 months after completion of neoadjuvant chemotherapy treatment
To evaluate self-reported data in terms of Sense of Coherence
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30)
Time frame: Up to 3 months after completion of neoadjuvant chemotherapy treatment
To evaluate self-reported data in terms of health related quality of life
Questionnaire Memorial Symptom Assessment Scale (MSAS)
Time frame: Up to 3 months after completion of neoadjuvant chemotherapy treatment
To evaluate self-reported data in terms of symptom prevalence, characteristics and distress
1 secondary outcome
Health care costs
Time frame: Up to 3 months after completion of neoadjuvant chemotherapy treatment
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 8 Aug 2018.
- Derived from this study: PubMed 42872750Crafoord MT, Fjell M, Gustavell T. Exploring Patients' Care Needs in Digital Free-Text Messages During Cancer Treatment: Qualitative Analysis Guided by the Fundamentals of Care Framework. J Adv Nurs. 2026 Oct 14. doi: 10.1111/jan.70781. Online ahead of print.
- Derived from this study: PubMed 40067346Crafoord MT, Ekstrand J, Sundberg K, Nilsson MI, Fjell M, Langius-Eklof A. Mobile Electronic Patient-Reported Outcomes and Interactive Support During Breast and Prostate Cancer Treatment: Health Economic Evaluation From Two Randomized Controlled Trials. JMIR Cancer. 2025 Mar 11;11:e53539. doi: 10.2196/53539.
- Derived from this study: PubMed 28676102Langius-Eklof A, Crafoord MT, Christiansen M, Fjell M, Sundberg K. Effects of an interactive mHealth innovation for early detection of patient-reported symptom distress with focus on participatory care: protocol for a study based on prospective, randomised, controlled trials in patients with prostate and breast cancer. BMC Cancer. 2017 Jul 4;17(1):466. doi: 10.1186/s12885-017-3450-y.
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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.
Ann Langius-Eklöf, RN, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone or tablet in people with Breast Cancer, run by Karolinska Institutet at 1 site in Sweden.
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 3 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 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Questionnaire Scale for Functional Health Literacy (S-FHL-Swedish version) (time frame: Up to 3 months after completion of neoadjuvant chemotherapy treatment). The study lists 6 primary outcomes in all. 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 NCT02479607, which also lists 3 linked publications.
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 8 Aug 2018.