Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of an Interactive ICT-Platform for Assessment and Management of Symptoms in Patients Treated for Prostate 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: NCT02477137
Recruitment Status : Completed
First Posted : June 22, 2015
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
Karolinska University Hospital
Information provided by (Responsible Party):
Ann Langius-Eklöf, Karolinska Institutet

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: smartphone or tablet Not Applicable

Layout table for study information
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 - 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
Actual Study Start Date : July 20, 2015
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : March 7, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Intervention group
In combination with usual care according to the routines at the clinic, 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.
Device: smartphone or tablet
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 Name: Intervention

No Intervention: Control group
Usual care according to the routines at the clinic.



Primary Outcome Measures :
  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 Outcome Measures :
  1. Health care costs [ Time Frame: up to 3 months after completion of radiotherapy treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02477137


Locations
Layout table for location information
Sweden
Karolinska University Hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska Institutet
Karolinska University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Ann Langius-Eklöf, RN, PhD Karolinska Institutet
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ann Langius-Eklöf, PhD, RN, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02477137    
Other Study ID Numbers: PhONEME Prostate
First Posted: June 22, 2015    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ann Langius-Eklöf, Karolinska Institutet:
Prostate Cancer
Nursing
Health Literacy
Quality of Life
Radiotherapy
Oncology Nursing
Self Care
Symptom Management
Participatory Care
Person-centered Care
Information and Communication Technology
Patient-reported symptoms
Mobile device
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases