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Completed

NCT Number: NCT02479607

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Stockholm, 17176, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smartphone or tablet

Device

Other names: Intervention

Primary outcomes

  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 outcomes

  1. Health care costs

    Time frame: Up to 3 months after completion of neoadjuvant chemotherapy treatment

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Karolinska University Hospital

Registry information

Official study title

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

Acronym: PhONEME

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 24, 2015
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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