Breast Cancer, Quality of Life, Treatment Adherence, Treatment Side Effects
Conditions
Keywords
Digital support
Brief summary
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.
Detailed description
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.
Interventions
OTHERDigitized support
Access to information about the disease, treatment, side effects and self-care
Sponsors
ScientificMed Tech AB
AstraZeneca
Novartis Sverige AB
Bröstcancerförbundet
Stockholm South General Hospital
Capio St Gorans hospital
Karolinska University Hospital
Region Stockholm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hormone receptor positive breast cancer * On adjuvant endocrine treatment 0-16 weeks ago
Exclusion criteria
* Cognitively impaired * No access to a mobile phone or internet * Not understanding Swedish
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | Change from baseline to 12 months | 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 |
| 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) | Change from baseline to 12 months | 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 |
Countries
Sweden
Contacts
Primary ContactJenny Bergqvist
Backup ContactHallin, PI
Outcome results
None listed