PACED-digitized Support During Adjuvant Endocrine Therapy

Region Stockholm

Status: Enrolling

Conditions: Breast Cancer; Treatment Side Effects; Quality of Life; Treatment Adherence

Treatments: Other: Digitized support

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05084625

2021-02902

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Arm A- access to digitized support, an app

Experimental group

Description:

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

Treatment:

Other: Digitized support

Arm B-standard follow-up

No Intervention group

Description:

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