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Clinical Trials/NCT02477137
NCT02477137
Completed
Not Applicable

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

Karolinska Institutet1 site in 1 country150 target enrollmentJuly 20, 2015
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Karolinska Institutet
Enrollment
150
Locations
1
Primary Endpoint
EORTC Prostate-specific module (QLQ-PR25) Questionnaire
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 20, 2015
End Date
March 7, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ann Langius-Eklöf

PhD, RN, Professor

Karolinska Institutet

Eligibility Criteria

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

Outcomes

Primary Outcomes

EORTC Prostate-specific module (QLQ-PR25) Questionnaire

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: up to 3 months after completion of radiotherapy treatment

To evaluate self-reported data in terms of understanding and communicating health

Secondary Outcomes

  • Health care costs(up to 3 months after completion of radiotherapy treatment)

Study Sites (1)

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