PACED-digitized Support During Adjuvant Endocrine Therapy

NCT05084625 | Unknown DMC

• 1 other identifier: 2021-02902
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

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

Keywords

Digital support

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Arm A- access to digitized support, an app

EXPERIMENTAL

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

Arm B-standard follow-up

NO INTERVENTION

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

Interventions

Digitized support OTHER

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

Arm A- access to digitized support, an app

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hormone receptor positive breast cancer
• On adjuvant endocrine treatment 0-16 weeks ago

You may not qualify if:

• Cognitively impaired
• No access to a mobile phone or internet
• Not understanding Swedish

Sponsors & Collaborators

• Region Stockholm: lead
• ScientificMed Tech AB: collaborator
• AstraZeneca: collaborator
• Novartis Sverige AB: collaborator
• Bröstcancerförbundet: collaborator
• Stockholm South General Hospital: collaborator
• Capio St Gorans hospital: collaborator
• Karolinska University Hospital: collaborator

Study Sites (3)

Karolinska University Hospital

Stockholm, Sweden

NOT YET RECRUITING

Oncology department Capio St Gorans Hospital

Stockholm, Sweden

RECRUITING

Södersjukhuset

Stockholm, Sweden

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Health Behavior; Behavior

Study Officials

• Jenny Bergqvist

  St Gorans Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny Bergqvist

CONTACT

+46700891524; jenny.bergqvist@ki.se

Hallin, PI

CONTACT

+46700891524; charlotta.hallin@capiostgoran.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 20, 2021
• Study Start: October 25, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 17, 2024

Record last verified: 2023-12

Locations

SE (3)