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Completed

NCT Number: NCT02477137

Effects of an Interactive ICT-Platform for Assessment and Management of Symptoms in Patients Treated for Prostate Cancer

The purpose of this study is to evaluate the effects of an interactive ICT-platform for use in a smartphone or tablet in patients treated with radiotherapy for prostate 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

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

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

  • Diagnosis of prostate cancer without metastases or spread to the lymph nodes,
  • will receive radiation therapy for at least five (5) weeks,
  • 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

Patients in the intervention group are given access to an application for a smartphone/tablet for daily reporting of symptoms, access to self-care advice and health-care professionals in real time.

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 radiotherapy treatment

    To evaluate self-reported data in terms of understanding and communicating health

  2. Questionnaire Individualized Care Scale (ICS)

    Time frame: up to 3 months after completion of radiotherapy treatment

    To evaluate self-reported data in terms of individualized care as measured by the ICS

  3. Questionnaire Sense of Coherence Scale (KASAM)

    Time frame: up to 3 months after completion of radiotherapy treatment

    To evaluate self-reported data in terms of Sense of Coherence

  4. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30)

    Time frame: up to 3 months after completion of radiotherapy treatment

    To evaluate self-reported data in terms of health related quality of life

  5. EORTC Prostate-specific module (QLQ-PR25) Questionnaire

    Time frame: up to 3 months after completion of radiotherapy treatment

    To evaluate self-reported data in terms of symptom prevalence, characteristics and distress related to prostate cancer

  6. Scale for Communicative and Critical Health Literacy (S-C & C HL - Swedish version)

    Time frame: up to 3 months after completion of radiotherapy treatment

    To evaluate self-reported data in terms of health literacy

Secondary outcomes

  1. Health care costs

    Time frame: up to 3 months after completion of radiotherapy treatment

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Karolinska University Hospital

Registry information

Official study title

PhONEME - PartipatOn Ehealth MobilE. Effects of an Interactive Information and Communications Technology (ICT) Platform for Assessment and Management of Symptoms in Patients Treated for Prostate Cancer

Acronym: PhONEME

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 22, 2015
Registry last updated
Aug 31, 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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