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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: Smartphone or tablet

• Registration Number: NCT02479607
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-06-12
• Study First Submitted QC: 2015-06-23
• Study First Posted: 2015-06-24
• Study Start: 2015-06-30
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• The diagnosis of breast cancer
• Patients who will receive neoadjuvant chemotherapy
• Literacy in the Swedish language

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Exclusion Criteria

• Patients who need an interpreter at the doctor's visit
• Patients who have a known severe cognitive impairment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	Smartphone or tablet	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

Primary Outcome Measures

Name	Time	Method
Questionnaire Scale for Functional Health Literacy (S-FHL-Swedish version)	Up to 3 months after completion of neoadjuvant chemotherapy treatment	To evaluate self-reported data in terms of understanding health
Questionnaire Scale for Communicative and Critical Health Literacy (S-C & C HL - Swedish version)	Up to 3 months after completion of neoadjuvant chemotherapy treatment	To evaluate self-reported data in terms of communicating health
Questionnaire Individualized Care Scale (ICS)	Up to 3 months after completion of neoadjuvant chemotherapy treatment	To evaluate self-reported data in terms of individualized care
Questionnaire Sense of Coherence Scale (KASAM)	Up to 3 months after completion of neoadjuvant chemotherapy treatment	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)	Up to 3 months after completion of neoadjuvant chemotherapy treatment	To evaluate self-reported data in terms of health related quality of life
Questionnaire Memorial Symptom Assessment Scale (MSAS)	Up to 3 months after completion of neoadjuvant chemotherapy treatment	To evaluate self-reported data in terms of symptom prevalence, characteristics and distress

Secondary Outcome Measures

Name	Time	Method
Health care costs	Up to 3 months after completion of neoadjuvant chemotherapy treatment

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden