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PACED-digitized Support During Adjuvant Endocrine Therapy

Primary Purpose

Breast Cancer, Treatment Adherence, Quality of Life

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Digitized support
Sponsored by
Region Stockholm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Digital support

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Karolinska University Hospital
  • Oncology department Capio St Gorans HospitalRecruiting
  • Södersjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm A- access to digitized support, an app

Arm B-standard follow-up

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
October 6, 2021
Last Updated
April 18, 2023
Sponsor
Region Stockholm
Collaborators
ScientificMed Tech AB, AstraZeneca, Novartis Sverige AB, Bröstcancerförbundet, Stockholm South General Hospital, Capio St Gorans hospital, Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05084625
Brief Title
PACED-digitized Support During Adjuvant Endocrine Therapy
Official Title
PACED-Patient-centred Digital Support During Adjuvant Endocrine Breast Cancer Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Stockholm
Collaborators
ScientificMed Tech AB, AstraZeneca, Novartis Sverige AB, Bröstcancerförbundet, Stockholm South General Hospital, Capio St Gorans hospital, Karolinska University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Treatment Adherence, Quality of Life, Treatment Side Effects
Keywords
Digital support

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A- access to digitized support, an app
Arm Type
Experimental
Arm Description
Patients in Arm A will have access to digitized support-an app for 12 months from baseline in addition to standard follow-up.
Arm Title
Arm B-standard follow-up
Arm Type
No Intervention
Arm Description
Patients in Arm B-will continue with standard follow-up from baseline and onwards
Intervention Type
Other
Intervention Name(s)
Digitized support
Intervention Description
Access to information about the disease, treatment, side effects and self-care
Primary Outcome Measure Information:
Title
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).
Description
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
Time Frame
Change from baseline to 12 months
Title
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)
Description
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
Time Frame
Change from baseline to 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jenny Bergqvist
Phone
+46700891524
Email
jenny.bergqvist@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Hallin, PI
Phone
+46700891524
Email
charlotta.hallin@capiostgoran.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenny Bergqvist
Organizational Affiliation
St Gorans Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yvonne Wengström
Email
yvonne.wengstrom@ki.se
Facility Name
Oncology department Capio St Gorans Hospital
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenny Bergqvist
Facility Name
Södersjukhuset
City
Stockholm
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Larsson-Wrake

12. IPD Sharing Statement

Learn more about this trial

PACED-digitized Support During Adjuvant Endocrine Therapy

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