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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02477137 |
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Date of registration:
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12/06/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effects of an Interactive ICT-Platform for Assessment and Management of Symptoms in Patients Treated for Prostate Cancer
PhONEME |
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Scientific title:
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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 |
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Date of first enrolment:
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July 20, 2015 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02477137 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Ann Langius-Eklöf, RN, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Karolinska Institutet |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Prostate Cancer
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Intervention(s)
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Device: smartphone or tablet
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Primary Outcome(s)
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Questionnaire Sense of Coherence Scale (KASAM)
[Time Frame: up to 3 months after completion of radiotherapy treatment]
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Scale for Communicative and Critical Health Literacy (S-C & C HL - Swedish version)
[Time Frame: up to 3 months after completion of radiotherapy treatment]
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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]
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EORTC Prostate-specific module (QLQ-PR25) Questionnaire
[Time Frame: up to 3 months after completion of radiotherapy treatment]
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Questionnaire Individualized Care Scale (ICS)
[Time Frame: up to 3 months after completion of radiotherapy treatment]
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Questionnaire Scale for Functional Health Literacy (S-FHL - Swedish version)
[Time Frame: up to 3 months after completion of radiotherapy treatment]
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Secondary Outcome(s)
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Health care costs
[Time Frame: up to 3 months after completion of radiotherapy treatment]
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Secondary ID(s)
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PhONEME Prostate
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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