Breast CancerNCT05084625
PACED-digitized Support During Adjuvant Endocrine Therapy
A study testing Digitized support in people with Breast Cancer and Treatment Adherence, run by Region Stockholm at 3 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Treatment Adherence, Quality of Life
- What is being tested?
- Digitized support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesSweden
- Study dates
- 25 Oct 2021to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hormone receptor positive breast cancer
- On adjuvant endocrine treatment 0-16 weeks ago
Who cannot join
- Cognitively impaired
- No access to a mobile phone or internet
- Not understanding Swedish
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites, 3 recruiting
- Not yet recruiting
Karolinska University Hospital
Stockholm
Yvonne Wengström, yvonne.wengstrom@ki.se
- Recruiting
Oncology department Capio St Gorans Hospital
Stockholm
Jenny Bergqvist
- Not yet recruiting
Södersjukhuset
Stockholm
Anna Larsson-Wrake
About this study
Official title: 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.
Read the 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.
- Being tested
- Digitized support
- Keywords
- Digital support
- Medical subject headings
- Breast Neoplasms, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digitized supportOther
Access to information about the disease, treatment, side effects and self-care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Digitized support |
| Arm B-standard follow-up | No intervention | Patients in Arm B-will continue with standard follow-up from baseline and onwards |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Change from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start25 Oct 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- ScientificMed Tech AB, AstraZeneca, Novartis Sverige AB, Bröstcancerförbundet, Stockholm South General Hospital, St Goran's Hospital, Karolinska University Hospital
- Responsible party
- Sponsor
- Investigators
- Jenny Bergqvist, Principal investigator, St Gorans Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084625
- Sponsor's protocol ID
- 2021-02902
- Status last verified
- Dec 2023
- First submitted
- 6 Oct 2021
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PACED-Patient-centred Digital Support During Adjuvant Endocrine Breast Cancer Treatment
- ClinicalTrials.gov ID
- NCT05084625
- Acronym / sponsor ID
- 2021-02902
- Keywords
- Digital support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- ScientificMed Tech AB, AstraZeneca, Novartis Sverige AB, Bröstcancerförbundet, Stockholm South General Hospital, St Goran's Hospital, Karolinska University Hospital
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A- access to digitized support, an app | Experimental | Other: Digitized supportPatients in Arm A will have access to digitized support-an app for 12 months from baseline in addition to standard follow-up. |
| Arm B-standard follow-up | No intervention | –Patients in Arm B-will continue with standard follow-up from baseline and onwards |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hormone receptor positive breast cancer
- On adjuvant endocrine treatment 0-16 weeks ago
Key exclusion criteria (3 listed)
- Cognitively impaired
- No access to a mobile phone or internet
- Not understanding Swedish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digitized supportAccess to information about the disease, treatment, side effects and self-care | Other | Arm A- access to digitized support, an app |
Primary outcome
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).
Time frame: Change from baseline to 12 months
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)
Time frame: Change from baseline to 12 months
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenny Bergqvist principal investigator
St Gorans Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digitized support in people with Breast Cancer and Treatment Adherence, run by Region Stockholm at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jenny Bergqvist (+46700891524, jenny.bergqvist@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: Change from baseline to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.