Effects of an Interactive ICT-Platform for Assessment and Management of Symptoms in Patients Treated for Prostate Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: smartphone or tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Patients who need an interpreter at the doctor's visit Patients who have a known severe cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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. | Device: smartphone or tablet<br>* 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.<br>* Other names: Intervention;|
| No Intervention: Control group<br>Usual care according to the routines at the clinic. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire Scale for Functional Health Literacy (S-FHL - Swedish version) | To evaluate self-reported data in terms of understanding and communicating health | 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 | 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 | 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 | 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 | 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 | up to 3 months after completion of radiotherapy treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health care costs |  | up to 3 months after completion of radiotherapy treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Information and Communication Technology, Patient-reported symptoms, Prostate Cancer, Nursing, Health Literacy, Quality of Life, Radiotherapy, Oncology Nursing, Self Care, Symptom Management, Participatory Care, Person-centered Care, Mobile device