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

NCT ID: NCT02477137

Last Updated: 2018-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-20

Study Completion Date

2018-03-07

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention group

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.

Group Type EXPERIMENTAL

smartphone or tablet

Intervention Type DEVICE

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.

Control group

Usual care according to the routines at the clinic.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Intervention

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Ann Langius-Eklöf

PhD, RN, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ann Langius-Eklöf, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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Crafoord MT, Ekstrand J, Sundberg K, Nilsson MI, Fjell M, Langius-Eklof A. Mobile Electronic Patient-Reported Outcomes and Interactive Support During Breast and Prostate Cancer Treatment: Health Economic Evaluation From Two Randomized Controlled Trials. JMIR Cancer. 2025 Mar 11;11:e53539. doi: 10.2196/53539.

Reference Type DERIVED
PMID: 40067346 (View on PubMed)

Langius-Eklof A, Crafoord MT, Christiansen M, Fjell M, Sundberg K. Effects of an interactive mHealth innovation for early detection of patient-reported symptom distress with focus on participatory care: protocol for a study based on prospective, randomised, controlled trials in patients with prostate and breast cancer. BMC Cancer. 2017 Jul 4;17(1):466. doi: 10.1186/s12885-017-3450-y.

Reference Type DERIVED
PMID: 28676102 (View on PubMed)

Other Identifiers

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PhONEME Prostate

Identifier Type: -

Identifier Source: org_study_id

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