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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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 |
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| Control group | No Intervention | Standard care according to the clinic's routines. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartphone or tablet | Device |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire Scale for Functional Health Literacy (S-FHL-Swedish version) | To evaluate self-reported data in terms of understanding health | 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 | 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 | 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 | 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 | 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 | Up to 3 months after completion of neoadjuvant chemotherapy treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Health care costs | Up to 3 months after completion of neoadjuvant chemotherapy treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Langius-Eklöf, RN, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | 17176 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40067346 | Derived | Crafoord MT, Ekstrand J, Sundberg K, Nilsson MI, Fjell M, Langius-Eklof A. Mobile Electronic Patient-Reported Outcomes and Interactive Support During Breast and Prostate Cancer Treatment: Health Economic Evaluation From Two Randomized Controlled Trials. JMIR Cancer. 2025 Mar 11;11:e53539. doi: 10.2196/53539. | |
| 28676102 | Derived |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| 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. |
| D017437 |
| Skin and Connective Tissue Diseases |