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

NCT ID: NCT02479607

Last Updated: 2018-08-08

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

2015-06-30

Study Completion Date

2017-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast 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

Use of an application for a smartphone or tablet for daily reporting symptoms and access to self-care advice and health care professionals in real time in combination with standard care according to the clinic´s routines

Group Type EXPERIMENTAL

Smartphone or tablet

Intervention Type DEVICE

Control group

Standard care according to the clinic's routines.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Smartphone or tablet

Intervention Type DEVICE

Other Intervention Names

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Intervention

Eligibility Criteria

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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
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

RN, PhD, 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 Breast

Identifier Type: -

Identifier Source: org_study_id

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