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

N/ACompletedNCT02479607

Karolinska Institutet150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

150

Conditions

Interventions

Smartphone or tabletDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Karolinska University Hospital

Stockholm, Sweden

Outcomes

Primary Outcomes

Questionnaire Scale for Functional Health Literacy (S-FHL-Swedish version)

To evaluate self-reported data in terms of understanding health

Time frame: Up to 3 months after completion of neoadjuvant chemotherapy treatment

Questionnaire Scale for Communicative and Critical Health Literacy (S-C & C HL - Swedish version)

To evaluate self-reported data in terms of communicating health

Time frame: Up to 3 months after completion of neoadjuvant chemotherapy treatment

Questionnaire Individualized Care Scale (ICS)

To evaluate self-reported data in terms of individualized care

Time frame: Up to 3 months after completion of neoadjuvant chemotherapy treatment

Questionnaire Sense of Coherence Scale (KASAM)

To evaluate self-reported data in terms of Sense of Coherence

Time frame: Up to 3 months after completion of neoadjuvant chemotherapy treatment

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

Time frame: Up to 3 months after completion of neoadjuvant chemotherapy treatment

Questionnaire Memorial Symptom Assessment Scale (MSAS)

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 Outcomes

Health care costs

Data from ClinicalTrials.gov

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