Clinical trial NCT02479607: Effects of an ICT-platform for Assessment and Management of Patient-reported Symptoms During Treatment for Breast Cancer
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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2015-06-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Questionnaire Scale for Functional Health Literacy (S-FHL-Swedish version)
timeFrame: Up to 3 months after completion of neoadjuvant chemotherapy treatment
measure: Questionnaire Scale for Communicative and Critical Health Literacy (S-C & C HL - Swedish version)
timeFrame: Up to 3 months after completion of neoadjuvant chemotherapy treatment
measure: Questionnaire Individualized Care Scale (ICS)
timeFrame: Up to 3 months after completion of neoadjuvant chemotherapy treatment
measure: Questionnaire Sense of Coherence Scale (KASAM)
timeFrame: Up to 3 months after completion of neoadjuvant chemotherapy treatment
measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30)
timeFrame: Up to 3 months after completion of neoadjuvant chemotherapy treatment
measure: Questionnaire Memorial Symptom Assessment Scale (MSAS)
timeFrame: Up to 3 months after completion of neoadjuvant chemotherapy treatment
Secondary outcomes:
measure: Health care costs
timeFrame: Up to 3 months after completion of neoadjuvant chemotherapy treatment
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Ann Langius-Eklöf, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.