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

August 7, 2018 updated by: Ann Langius-Eklöf, Karolinska Institutet

PhONEME - ParticipatOn Ehealth MobilE. Effects of an Interactive ICT-platform for Assessment and Management of Symptoms in Patients Treated for Breast Cancer.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 17176
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: Smartphone or tablet
Other Names:
  • Intervention
No Intervention: Control group
Standard care according to the clinic's routines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire Scale for Functional Health Literacy (S-FHL-Swedish version)
Time Frame: Up to 3 months after completion of neoadjuvant chemotherapy treatment
To evaluate self-reported data in terms of understanding health
Up to 3 months after completion of neoadjuvant chemotherapy treatment
Questionnaire Scale for Communicative and Critical Health Literacy (S-C & C HL - Swedish version)
Time Frame: Up to 3 months after completion of neoadjuvant chemotherapy treatment
To evaluate self-reported data in terms of communicating health
Up to 3 months after completion of neoadjuvant chemotherapy treatment
Questionnaire Individualized Care Scale (ICS)
Time Frame: Up to 3 months after completion of neoadjuvant chemotherapy treatment
To evaluate self-reported data in terms of individualized care
Up to 3 months after completion of neoadjuvant chemotherapy treatment
Questionnaire Sense of Coherence Scale (KASAM)
Time Frame: Up to 3 months after completion of neoadjuvant chemotherapy treatment
To evaluate self-reported data in terms of Sense of Coherence
Up to 3 months after completion of neoadjuvant chemotherapy treatment
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30)
Time Frame: Up to 3 months after completion of neoadjuvant chemotherapy treatment
To evaluate self-reported data in terms of health related quality of life
Up to 3 months after completion of neoadjuvant chemotherapy treatment
Questionnaire Memorial Symptom Assessment Scale (MSAS)
Time Frame: Up to 3 months after completion of neoadjuvant chemotherapy treatment
To evaluate self-reported data in terms of symptom prevalence, characteristics and distress
Up to 3 months after completion of neoadjuvant chemotherapy treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Health care costs
Time Frame: Up to 3 months after completion of neoadjuvant chemotherapy treatment
Up to 3 months after completion of neoadjuvant chemotherapy treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Karolinska University Hospital

Investigators

  • Principal Investigator: Ann Langius-Eklöf, RN, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2015

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

June 12, 2015

First Submitted That Met QC Criteria

June 23, 2015

First Posted (Estimate)

June 24, 2015

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PhONEME Breast

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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