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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Device: smartphone or tablet

• Registration Number: NCT02477137
• Lead Sponsor: Karolinska Institutet

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-06-12
• Study First Submitted QC: 2015-06-19
• Study First Posted: 2015-06-22
• Study Start: 2015-07-20
• Primary Completion: 2018-03-01
• Study Completion: 2018-03-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-29
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

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Exclusion Criteria

• Patients who need an interpreter at the doctor's visit
• Patients who have a known severe cognitive impairment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	smartphone or tablet	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.

Primary Outcome Measures

Name	Time	Method
EORTC Prostate-specific module (QLQ-PR25) Questionnaire	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)	up to 3 months after completion of radiotherapy treatment	To evaluate self-reported data in terms of health literacy
Questionnaire Sense of Coherence Scale (KASAM)	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)	up to 3 months after completion of radiotherapy treatment	To evaluate self-reported data in terms of health related quality of life
Questionnaire Individualized Care Scale (ICS)	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 Scale for Functional Health Literacy (S-FHL - Swedish version)	up to 3 months after completion of radiotherapy treatment	To evaluate self-reported data in terms of understanding and communicating health

Secondary Outcome Measures

Name	Time	Method
Health care costs	up to 3 months after completion of radiotherapy treatment

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden