Skip to main content
Clinical Trials/NCT02479607
NCT02479607
Completed
Not Applicable

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

Karolinska Institutet1 site in 1 country150 target enrollmentJune 30, 2015
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Karolinska Institutet
Enrollment
150
Locations
1
Primary Endpoint
Questionnaire Scale for Functional Health Literacy (S-FHL-Swedish version)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 30, 2015
End Date
October 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ann Langius-Eklöf

RN, PhD, Professor

Karolinska Institutet

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

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

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

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

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

Secondary Outcomes

  • Health care costs(Up to 3 months after completion of neoadjuvant chemotherapy treatment)

Study Sites (1)

Loading locations...

Similar Trials