Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Breast Diseases

Skin Diseases

Quality of Life

Patients in Arm A will have access to digitized support-an app for 12 months from baseline in addition to standard follow-up.

Patients in Arm B-will continue with standard follow-up from baseline and onwards

Access to information about the disease, treatment, side effects and self-care

Digitized support

Jenny Bergqvist

Hallin, PI

Yvonne Wengström

Anna Larsson-Wrake

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.

PACED-digitized Support During Adjuvant Endocrine Therapy

PACED-Patient-centred Digital Support During Adjuvant Endocrine Breast Cancer Treatment

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PACED-digitized Support During Adjuvant Endocrine Therapy	NCT05084625	Breast Cancer Treatment Adher... Quality of Life Treatment Side ...	Digitized suppo...	18 Years -	Region Stockholm
PACED-digitized Support During Adjuvant Endocrine Therapy	NCT05084625	Breast Cancer Treatment Adher... Quality of Life Treatment Side ...	Digitized suppo...	18 Years -	Region Stockholm

Spots Global Cancer Trial Database for digital support