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

Breast Cancer Clinical Trial

— PhONEME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02479607
• Other study ID #: PhONEME Breast
• Status: Completed
• Phase: N/A
• Start date: June 30, 2015
• Est. completion date: October 2017

Study information

• Verified date: August 2018
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Smartphone or tablet

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Health care costs		Up to 3 months after completion of neoadjuvant chemotherapy treatment