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| Name | Class |
|---|---|
| ScientificMed Tech AB | UNKNOWN |
| AstraZeneca | INDUSTRY |
| Novartis Sverige AB | UNKNOWN |
| Bröstcancerförbundet |
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The research team want to investigate whether digital support, an app under preventive hormonal breast cancer treatment can lead to less late side effects, better quality of life and increased adherence to treatment.
Patients with hormon receptor positive breast cancer and adjuvant endocrine treatment will be invited to participate in the study after adjuvant radiotherapy is completed. Participants will be randomised to 12 months of access to a digital support-an app-in addition to standard follow-up or standard follow-up. Research team want to investigate whether digital support under hormonal breast cancer treatment can lead to less late side effects, better quality of life and increased adherence to treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A- access to digitized support, an app | Experimental | Patients in Arm A will have access to digitized support-an app for 12 months from baseline in addition to standard follow-up. |
|
| Arm B-standard follow-up | No Intervention | Patients in Arm B-will continue with standard follow-up from baseline and onwards |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digitized support | Other | Access to information about the disease, treatment, side effects and self-care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference between the two groups with regard to change in quality of life from baseline to 12 months measured by Questionnaires European Organisation for Research and Treatment for Cancer Quality of life C30 (EORTC QLQ C30). | EORTC QLQ C30. All of the scales and single-item measures range in score from 0 to100. A high scale score represents a higher response level. For a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. A 'little' change for better or worse on a particular scale (function or symptom) defined as changes about 5 to 10. "Moderate" change have changed about 10 to 20, and 'very much' change corresponded to a change greater than 20. Our population sample is based on that a change should be of effect size (Cohen's d) difference of 0.54 (which correspond to a moderate change) at the end of access to digital support in the primary outcome of symptom burden and quality of life, 90% power at P < .01 | Change from baseline to 12 months |
| Difference between the two groups with regard to change in quality of life from baseline to 12 months by Questionnaires European Organisation for Research and Treatment for Cancer Quality of life Breast cancerrelated 23 (EORTC QLQ BR23) | EORTC QLQ BR23. All of the scales and single-item measures range in score from 0 to100. A high scale score represents a higher response level. For a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. A 'little' change for better or worse on a particular scale (function or symptom) defined as changes about 5 to 10. "Moderate" change have changed about 10 to 20, and 'very much' change corresponded to a change greater than 20. BR23 recommended with C30. Our population sample is based on that a change should be of effect size (Cohen's d) difference of 0.54 (which correspond to a moderate change) at the end of access to digital support in the primary outcome of symptom burden and quality of life, 90% power at P < .01 | Change from baseline to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jenny Bergqvist | Contact | +46700891524 | jenny.bergqvist@ki.se | |
| Hallin, PI | Contact | +46700891524 | charlotta.hallin@capiostgoran.se |
| Name | Affiliation | Role |
|---|---|---|
| Jenny Bergqvist | St Gorans Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Not yet recruiting | Stockholm | Sweden |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| UNKNOWN |
| Stockholm South General Hospital | OTHER |
| Capio St Gorans hospital | UNKNOWN |
| Karolinska University Hospital | OTHER |
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| Oncology department Capio St Gorans Hospital | Recruiting | Stockholm | Sweden |
|
| Södersjukhuset | Not yet recruiting | Stockholm | Sweden |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |