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
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
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Stockholm, Sweden, 17176
- Karolinska University Hospital
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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 |
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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
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Other Names:
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No Intervention: Control group
Standard care according to the clinic's routines.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Questionnaire Scale for Functional Health Literacy (S-FHL-Swedish version)
Time Frame: Up to 3 months after completion of neoadjuvant chemotherapy treatment
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To evaluate self-reported data in terms of understanding health
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Up to 3 months after completion of neoadjuvant chemotherapy treatment
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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
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To evaluate self-reported data in terms of communicating health
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Up to 3 months after completion of neoadjuvant chemotherapy treatment
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Questionnaire Individualized Care Scale (ICS)
Time Frame: Up to 3 months after completion of neoadjuvant chemotherapy treatment
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To evaluate self-reported data in terms of individualized care
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Up to 3 months after completion of neoadjuvant chemotherapy treatment
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Questionnaire Sense of Coherence Scale (KASAM)
Time Frame: Up to 3 months after completion of neoadjuvant chemotherapy treatment
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To evaluate self-reported data in terms of Sense of Coherence
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Up to 3 months after completion of neoadjuvant chemotherapy treatment
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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
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To evaluate self-reported data in terms of health related quality of life
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Up to 3 months after completion of neoadjuvant chemotherapy treatment
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Questionnaire Memorial Symptom Assessment Scale (MSAS)
Time Frame: Up to 3 months after completion of neoadjuvant chemotherapy treatment
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To evaluate self-reported data in terms of symptom prevalence, characteristics and distress
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Up to 3 months after completion of neoadjuvant chemotherapy treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Health care costs
Time Frame: Up to 3 months after completion of neoadjuvant chemotherapy treatment
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Up to 3 months after completion of neoadjuvant chemotherapy treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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.
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.