PACED-digitized Support During Adjuvant Endocrine Therapy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Breast Cancer; Treatment Side Effects; Treatment Adherence
• Intervention / Treatment: Other: Digitized support

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jenny Bergqvist; Phone Number: +46700891524; Email: jenny.bergqvist@ki.se
• Study Contact Backup: Name: Hallin, PI; Phone Number: +46700891524; Email: charlotta.hallin@capiostgoran.se

Study Locations

• Sweden
  • Stockholm, Sweden
    • Not yet recruiting
    • Karolinska University Hospital
    • Contact: Yvonne Wengström; Email: yvonne.wengstrom@ki.se
  • Stockholm, Sweden
    • Not yet recruiting
    • Sodersjukhuset
    • Contact: Anna Larsson-Wrake
  • Stockholm, Sweden
    • Recruiting
    • Oncology department Capio St Gorans Hospital
    • Contact: Jenny Bergqvist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Digitized support; Access to information about the disease, treatment, side effects and self-care
No Intervention: Arm B-standard follow-up; Patients in Arm B-will continue with standard follow-up from baseline and onwards

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Region Stockholm
• Collaborators: Karolinska University Hospital; AstraZeneca; Stockholm South General Hospital; ScientificMed Tech AB; Novartis Sverige AB; Bröstcancerförbundet; Capio St Gorans hospital
• Investigators: Principal Investigator: Jenny Bergqvist, St Gorans Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 6, 2021
• First Submitted That Met QC Criteria: October 19, 2021
• First Posted (Actual): October 20, 2021

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Digital support
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2021-02902

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No