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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
smartphone or tablet
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

Usual care according to the routines at the clinic.

Outcomes

Primary Outcome Measures

Questionnaire Scale for Functional Health Literacy (S-FHL - Swedish version)
To evaluate self-reported data in terms of understanding and communicating health
Questionnaire Individualized Care Scale (ICS)
To evaluate self-reported data in terms of individualized care as measured by the ICS
Questionnaire Sense of Coherence Scale (KASAM)
To evaluate self-reported data in terms of Sense of Coherence
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30)
To evaluate self-reported data in terms of health related quality of life
EORTC Prostate-specific module (QLQ-PR25) Questionnaire
To evaluate self-reported data in terms of symptom prevalence, characteristics and distress related to prostate cancer
Scale for Communicative and Critical Health Literacy (S-C & C HL - Swedish version)
To evaluate self-reported data in terms of health literacy

Secondary Outcome Measures

Health care costs

Full Information

First Posted
June 12, 2015
Last Updated
August 29, 2018
Sponsor
Karolinska Institutet
Collaborators
Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02477137
Brief Title
Effects of an Interactive ICT-Platform for Assessment and Management of Symptoms in Patients Treated for Prostate Cancer
Acronym
PhONEME
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 20, 2015 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
March 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Karolinska University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual care according to the routines at the clinic.
Intervention Type
Device
Intervention Name(s)
smartphone or tablet
Other Intervention Name(s)
Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Questionnaire Scale for Functional Health Literacy (S-FHL - Swedish version)
Description
To evaluate self-reported data in terms of understanding and communicating health
Time Frame
up to 3 months after completion of radiotherapy treatment
Title
Questionnaire Individualized Care Scale (ICS)
Description
To evaluate self-reported data in terms of individualized care as measured by the ICS
Time Frame
up to 3 months after completion of radiotherapy treatment
Title
Questionnaire Sense of Coherence Scale (KASAM)
Description
To evaluate self-reported data in terms of Sense of Coherence
Time Frame
up to 3 months after completion of radiotherapy treatment
Title
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30)
Description
To evaluate self-reported data in terms of health related quality of life
Time Frame
up to 3 months after completion of radiotherapy treatment
Title
EORTC Prostate-specific module (QLQ-PR25) Questionnaire
Description
To evaluate self-reported data in terms of symptom prevalence, characteristics and distress related to prostate cancer
Time Frame
up to 3 months after completion of radiotherapy treatment
Title
Scale for Communicative and Critical Health Literacy (S-C & C HL - Swedish version)
Description
To evaluate self-reported data in terms of health literacy
Time Frame
up to 3 months after completion of radiotherapy treatment
Secondary Outcome Measure Information:
Title
Health care costs
Time Frame
up to 3 months after completion of radiotherapy treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Langius-Eklöf, RN, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28676102
Citation
Langius-Eklof A, Crafoord MT, Christiansen M, Fjell M, Sundberg K. Effects of an interactive mHealth innovation for early detection of patient-reported symptom distress with focus on participatory care: protocol for a study based on prospective, randomised, controlled trials in patients with prostate and breast cancer. BMC Cancer. 2017 Jul 4;17(1):466. doi: 10.1186/s12885-017-3450-y.
Results Reference
derived

Learn more about this trial

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

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