Breast Cancer
Conditions
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
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.
Interventions
DEVICESmartphone or tablet
Sponsors
Karolinska University Hospital
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Health care costs | Up to 3 months after completion of neoadjuvant chemotherapy treatment |
Countries
Sweden
Outcome results
None listed