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

Prostate Cancer Clinical Trial

— PhONEME  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02477137
• Other study ID #: PhONEME Prostate
• Status: Completed
• Phase: N/A
• Start date: July 20, 2015
• Est. completion date: March 7, 2018

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 7, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• smartphone or tablet
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.

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 and communicating health	up to 3 months after completion of radiotherapy treatment
Primary	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
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 radiotherapy treatment
Primary	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
Primary	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
Primary	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	Health care costs		up to 3 months after completion of radiotherapy treatment