PACED-digitized Support During Adjuvant Endocrine Therapy

NCT ID: NCT05084625

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-25

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer Treatment Adherence Quality of Life Treatment Side Effects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm A- access to digitized support, an app

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

Group Type EXPERIMENTAL

Digitized support

Intervention Type OTHER

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

Arm B-standard follow-up

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Digitized support

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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ScientificMed Tech AB

UNKNOWN

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role collaborator

Novartis Sverige AB

UNKNOWN

Sponsor Role collaborator

Bröstcancerförbundet

UNKNOWN

Sponsor Role collaborator

Stockholm South General Hospital

OTHER

Sponsor Role collaborator

Capio St Gorans hospital

UNKNOWN

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role collaborator

Region Stockholm

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jenny Bergqvist

Role: PRINCIPAL_INVESTIGATOR

St Gorans Hospital

Locations

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Karolinska University Hospital

Stockholm, , Sweden

Site Status NOT_YET_RECRUITING

Oncology department Capio St Gorans Hospital

Stockholm, , Sweden

Site Status RECRUITING

Södersjukhuset

Stockholm, , Sweden

Site Status NOT_YET_RECRUITING

Countries

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Sweden

Central Contacts

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Jenny Bergqvist

Role: CONTACT

+46700891524

Hallin, PI

Role: CONTACT

+46700891524

Facility Contacts

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Yvonne Wengström

Role: primary

Jenny Bergqvist

Role: primary

Anna Larsson-Wrake

Role: primary

Other Identifiers

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2021-02902

Identifier Type: -

Identifier Source: org_study_id

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