PACED-digitized Support During Adjuvant Endocrine Therapy

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05084625
• Other study ID #: 2021-02902
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2021
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Region Stockholm
• Contact: Jenny Bergqvist
• Phone: +46700891524
• Email: jenny.bergqvist[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Quality of Life
• Treatment Adherence
• Treatment Side Effects

Intervention

Other:
• Digitized support
Access to information about the disease, treatment, side effects and self-care

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm
Sweden	Oncology department Capio St Gorans Hospital	Stockholm
Sweden	Södersjukhuset	Stockholm

Sponsors (8)

Lead Sponsor	Collaborator
Region Stockholm	AstraZeneca, Bröstcancerförbundet, Capio St Gorans hospital, Karolinska University Hospital, Novartis Sverige AB, ScientificMed Tech AB, Stockholm South General Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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