Effects of an ICT-platform for Assessment and Management of Patient-reported Symptoms During Treatment for Breast Cancer

Study Overview
=================
Brief 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. 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
-----------------
PhONEME - ParticipatOn Ehealth MobilE. Effects of an Interactive ICT-platform for Assessment and Management of Symptoms in Patients Treated for Breast Cancer.

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: Smartphone or tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The diagnosis of breast cancer Patients who will receive neoadjuvant chemotherapy 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
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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>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 | Device: Smartphone or tablet<br> <br> * Other names: Intervention;|
| No Intervention: Control group<br>Standard care according to the clinic's routines. | |

What is the study measuring?
-----------------
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 health | 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 | 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 | 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 | 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 | 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 | Up to 3 months after completion of neoadjuvant chemotherapy treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health care costs |  | Up to 3 months after completion of neoadjuvant chemotherapy treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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