search
Back to results

Effects of an ICT-platform for Assessment and Management of Patient-reported Symptoms During Treatment for Breast Cancer (PhONEME)

Primary Purpose

Breast 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 Breast Cancer focused on measuring Breast Cancer, Cytostatic Agents, Nursing, Health Literacy, Quality of Life, 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:

  • 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

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

Use of an application for a smartphone or tablet for daily reporting symptoms and access to self-care advice and health care professionals in real time in combination with standard care according to the clinic´s routines

Standard care according to the clinic's routines.

Outcomes

Primary Outcome Measures

Questionnaire Scale for Functional Health Literacy (S-FHL-Swedish version)
To evaluate self-reported data in terms of understanding health
Questionnaire Scale for Communicative and Critical Health Literacy (S-C & C HL - Swedish version)
To evaluate self-reported data in terms of communicating health
Questionnaire Individualized Care Scale (ICS)
To evaluate self-reported data in terms of individualized care
Questionnaire Sense of Coherence Scale (KASAM)
To evaluate self-reported data in terms of Sense of Coherence
European Organisation 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
Questionnaire Memorial Symptom Assessment Scale (MSAS)
To evaluate self-reported data in terms of symptom prevalence, characteristics and distress

Secondary Outcome Measures

Health care costs

Full Information

First Posted
June 12, 2015
Last Updated
August 7, 2018
Sponsor
Karolinska Institutet
Collaborators
Karolinska University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02479607
Brief Title
Effects of an ICT-platform for Assessment and Management of Patient-reported Symptoms During Treatment for Breast Cancer
Acronym
PhONEME
Official Title
PhONEME - ParticipatOn Ehealth MobilE. Effects of an Interactive ICT-platform for Assessment and Management of Symptoms in Patients Treated for Breast Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 30, 2015 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Cytostatic Agents, Nursing, Health Literacy, Quality of Life, 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
Use of an application for a smartphone or tablet for daily reporting symptoms and access to self-care advice and health care professionals in real time in combination with standard care according to the clinic´s routines
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard care according to the clinic's routines.
Intervention Type
Device
Intervention Name(s)
Smartphone or tablet
Other Intervention Name(s)
Intervention
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 health
Time Frame
Up to 3 months after completion of neoadjuvant chemotherapy treatment
Title
Questionnaire Scale for Communicative and Critical Health Literacy (S-C & C HL - Swedish version)
Description
To evaluate self-reported data in terms of communicating health
Time Frame
Up to 3 months after completion of neoadjuvant chemotherapy treatment
Title
Questionnaire Individualized Care Scale (ICS)
Description
To evaluate self-reported data in terms of individualized care
Time Frame
Up to 3 months after completion of neoadjuvant chemotherapy 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 neoadjuvant chemotherapy treatment
Title
European Organisation 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 neoadjuvant chemotherapy treatment
Title
Questionnaire Memorial Symptom Assessment Scale (MSAS)
Description
To evaluate self-reported data in terms of symptom prevalence, characteristics and distress
Time Frame
Up to 3 months after completion of neoadjuvant chemotherapy treatment
Secondary Outcome Measure Information:
Title
Health care costs
Time Frame
Up to 3 months after completion of neoadjuvant chemotherapy treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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

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 ICT-platform for Assessment and Management of Patient-reported Symptoms During Treatment for Breast Cancer

We'll reach out to this number within 24 hrs