Prostate CancerPhONEMENCT02477137
Effects of an Interactive ICT-Platform for Assessment and Management of Symptoms in Patients Treated for Prostate Cancer
A study testing smartphone or tablet in people with Prostate 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 ICT-platform for use in a smartphone or tablet in patients treated with radiotherapy for prostate cancer. The hypothesis is that clinical management will be improved and costs reduced and safe and participatory care promoted, when patients report… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate 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
- 20 Jul 2015to 7 Mar 2018
- 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
- Diagnosis of prostate cancer without metastases or spread to the lymph nodes,
- will receive radiation therapy for at least five (5) weeks,
- 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 - PartipatOn Ehealth MobilE. Effects of an Interactive Information and Communications Technology (ICT) Platform for Assessment and Management of Symptoms in Patients Treated for Prostate Cancer
The purpose of this study is to evaluate the effects of an interactive ICT-platform for use in a smartphone or tablet in patients treated with radiotherapy for prostate 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
- Prostate Cancer
- Being tested
- smartphone or tablet
- Keywords
- Prostate Cancer, Nursing, Health Literacy, Quality of Life, Radiotherapy, Oncology Nursing, Self Care, Symptom Management, Participatory Care, Person-centered Care, Information and Communication Technology, Patient-reported symptoms, Mobile device
- Medical subject headings
- Prostatic 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
Patients in the intervention group are given access to an application for a smartphone/tablet for daily reporting of symptoms, access to self-care advice and health-care professionals in real time.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | In combination with usual care according to the routines at the clinic, patients in the intervention group are given access to an application for a smartphone/tablet for daily reporting of symptoms, access to self-care advice and health-care professionals in real time. Receives: Device: smartphone or tablet |
| Control group | No intervention | Usual care according to the routines at the clinic. |
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 and communicating health
Measured: up to 3 months after completion of radiotherapy treatment
Questionnaire Individualized Care Scale (ICS)
To evaluate self-reported data in terms of individualized care as measured by the ICS
Measured: up to 3 months after completion of radiotherapy 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 radiotherapy treatment
European Organization 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 radiotherapy treatment
EORTC Prostate-specific module (QLQ-PR25) Questionnaire
To evaluate self-reported data in terms of symptom prevalence, characteristics and distress related to prostate cancer
Measured: up to 3 months after completion of radiotherapy treatment
Scale for Communicative and Critical Health Literacy (S-C & C HL - Swedish version)
To evaluate self-reported data in terms of health literacy
Measured: up to 3 months after completion of radiotherapy treatment
Secondary outcomes (1)
Health care costs
Measured: up to 3 months after completion of radiotherapy treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2015 (estimated)
- Study start20 Jul 2015
- Primary completion1 Mar 2018
- Study completion7 Mar 2018
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 Prostate 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
- NCT02477137
- Sponsor's protocol ID
- PhONEME Prostate
- Acronym
- PhONEME
- Status last verified
- Aug 2018
- First submitted
- 12 Jun 2015
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PhONEME - PartipatOn Ehealth MobilE. Effects of an Interactive Information and Communications Technology (ICT) Platform for Assessment and Management of Symptoms in Patients Treated for Prostate Cancer
- ClinicalTrials.gov ID
- NCT02477137
- Acronym / sponsor ID
- PhONEME / PhONEME Prostate
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Nursing, Health Literacy, Quality of Life, Radiotherapy, 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
- 20 Jul 2015 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 7 Mar 2018 (actual)
- First posted
- 22 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 ICT-platform for use in a smartphone or tablet in patients treated with radiotherapy for prostate 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 tabletIn combination with usual care according to the routines at the clinic, patients in the intervention group are given access to an application for a smartphone/tablet for daily reporting of symptoms, access to self-care advice and health-care professionals in real time. |
| Control group | No intervention | –Usual care according to the routines at the clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of prostate cancer without metastases or spread to the lymph nodes,
- will receive radiation therapy for at least five (5) weeks,
- 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: InterventionPatients in the intervention group are given access to an application for a smartphone/tablet for daily reporting of symptoms, access to self-care advice and health-care professionals in real time. | Device | Intervention group |
Primary outcome
Questionnaire Scale for Functional Health Literacy (S-FHL - Swedish version)
Time frame: up to 3 months after completion of radiotherapy treatment
To evaluate self-reported data in terms of understanding and communicating health
Questionnaire Individualized Care Scale (ICS)
Time frame: up to 3 months after completion of radiotherapy treatment
To evaluate self-reported data in terms of individualized care as measured by the ICS
Questionnaire Sense of Coherence Scale (KASAM)
Time frame: up to 3 months after completion of radiotherapy treatment
To evaluate self-reported data in terms of Sense of Coherence
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30)
Time frame: up to 3 months after completion of radiotherapy treatment
To evaluate self-reported data in terms of health related quality of life
EORTC Prostate-specific module (QLQ-PR25) Questionnaire
Time frame: up to 3 months after completion of radiotherapy treatment
To evaluate self-reported data in terms of symptom prevalence, characteristics and distress related to prostate cancer
Scale for Communicative and Critical Health Literacy (S-C & C HL - Swedish version)
Time frame: up to 3 months after completion of radiotherapy treatment
To evaluate self-reported data in terms of health literacy
1 secondary outcome
Health care costs
Time frame: up to 3 months after completion of radiotherapy 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 31 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.
- Individual participant dataSharing planned: Undecided
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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 Prostate 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 31 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 radiotherapy 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 NCT02477137, 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 31 Aug 2018.