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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02479607
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
Karolinska University Hospital
Information provided by (Responsible Party):
Ann Langius-Eklöf, Karolinska Institutet

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Smartphone or tablet Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: PhONEME - ParticipatOn Ehealth MobilE. Effects of an Interactive ICT-platform for Assessment and Management of Symptoms in Patients Treated for Breast Cancer.
Actual Study Start Date : June 30, 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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 Name: Intervention
No Intervention: Control group
Standard care according to the clinic's routines.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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 Outcome Measures :
  1. Health care costs [ Time Frame: Up to 3 months after completion of neoadjuvant chemotherapy treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02479607


Locations
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Sweden
Karolinska University Hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska Institutet
Karolinska University Hospital
Investigators
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Principal Investigator: Ann Langius-Eklöf, RN, PhD Karolinska Institutet
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ann Langius-Eklöf, RN, PhD, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02479607    
Other Study ID Numbers: PhONEME Breast
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Keywords provided by Ann Langius-Eklöf, Karolinska Institutet:
Breast Cancer
Cytostatic Agents
Nursing
Health Literacy
Quality of Life
Oncology Nursing
Self Care
 Symptom Management
Participatory Care
Person-centered Care
Information and Communication Technology
Patient-reported symptoms
Mobile device
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases