Breast CancerNCT05085678
Co'Moon for Supporting Breast Cancer Patients on Adjuvant Endocrine Therapy
A study testing Co'moon (online website to support women with AET) in people with Breast Cancer and Quality of Life, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The objective of the study is to evaluate the effect of an online tool, based on patient reported outcomes (Co'moon), on the quality of life of breast cancer patients on adjuvant endocrine therapy in the University Hospital Leuven. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Quality of Life, Self Efficacy
- What is being tested?
- Co'moon (online website to support women with AET)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2020to 31 Dec 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women
- Older than 18 years
- Speaking, understanding and writing Dutch fluently
- Mentally competent
- Recently underwent a operation for breast cancer (invasive or in situ)
- Takes AET for maximum two months
Show all 9Show fewer
- Consultation planned within 4-5 month
- Home access of a computer with internet connection
- Contact with patient(s) included in the trial
Who cannot join
- Different treatments regimes (e.g. adjuvant trial or a combination with cycline-dependent kinase (CDK) 4/6-inhibitors)
- Metastatic disease
- Included in panels
- Member of the research team
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Evaluation of a PROMs-based Interactive Programme as a Supporting Tool for Breast Cancer Patients Using Adjuvant Endocrine Therapy
The objective of the study is to evaluate the effect of an online tool, based on patient reported outcomes (Co'moon), on the quality of life of breast cancer patients on adjuvant endocrine therapy in the University Hospital Leuven.
Read the detailed description
The project aims to develop and evaluate an online programme to support patients with breast cancer on adjuvant endocrine therapy in the University Hospital Leuven. The tool "Co'moon" has been developed in the first phase of the project and secondly refine in a pilot study. In the third phase a randomised controlled study investigates the effect of Co'moon in comparison with the standard of care in the University Hospital Leuven. Hereby focussing on the improvement of self-efficacy en quality of life.
- Conditions
- Breast Cancer, Quality of Life, Self Efficacy
- Being tested
- Co'moon (online website to support women with AET)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co'moon (online website to support women with AET)Device
Also called Class 1 medical device
The tool contains three parts:
- e-learning based on the brochure on adjuvant endocrine therapy (AET) in the University Hospital Leuven,
- serious game where patients are confronted with scenes of their daily life and motivational guidelines to stimulate their self-management,
- a patient-reported-outcome questionnaire (PROMs), reported in the patient medical file.
The tool is designed to stimulate patients self-management of their menopausal AET-related complaints and to discuss them with their health care professionals .
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Standard of care: * a short overview of the physician on adjuvant endocrine therapy * a brochure on adjuvant endocrine therapy * a voluntary group session on adjuvant endocrine therapy and a monthly questionnaire on the patient reported outcomes |
| Intervention group | Experimental | Standard care with the access of to the online tool Co'moon and a monthly questionnaire on patient reported outcomes.
The outcome of the questionnaires are summarized for the physician to discuss during the follow-up consultation. Receives: Device: Co'moon (online website to support women with AET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of Life - FACT-ES - B5 - H18
Total score of Functional Assessment of Chronic Illness Therapy system of Quality of Life questionnaires of endocrine symptoms (FACT-ES) combined with additional questions B5 and H18. A validated questionnaire with a 5-point Likert scale and a total score of 180 (high QoL).
Measured: monthly after two months of AET; up to 3 months
Change in self-efficacy
patient reported impact on the side effects of AET
Measured: month 3 and 6 or 7 after the start with AET
Therapy adherence
patient reported intentional or accidental forgot the medication
Measured: monthly after two months of AET; up to 3 months
Questionnaire on patients experience with the patient-physician relationship
patient reported their experience of the follow-up consultation in a 5 point Likert scale questionnaire
Measured: month 6 or 7 after the start with AET
Questionnaire on change in patient-relative communication over a period of +/- 3 months
patient reported a change in the communication of patients with their relatives in a 5 point Likert scale questionnaire
Measured: month 3 and 6 or 7 after the start with AET
Secondary outcomes (3)
Patient reported outcomes
Subscales of FACT-ES combined with additional questions B5 and H18.
Measured: Monthly after two months of AET; up to 3 months
Questionnaire on the experience of the healthcare professional regarding the summary of PRO's
the experience of healthcare professionals with the consultation with a 5 point Likert scale questionnaire (1 = strongly disagree, and 5 = strongly agree). The maximum score is 25.
Measured: month 6 or 7 after the start of AET
Time-spend on Co'moon
Logging of the time women spend on Co'moon
Measured: up to 3 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 start1 Dec 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
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.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Model description
- Randomised controlled trial with convenience sampling
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
- Investigators
- Ines Nevelsteen, Phd, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085678
- Sponsor's protocol ID
- G0F9119N
- Status last verified
- May 2022
- First submitted
- 13 Aug 2021
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a PROMs-based Interactive Programme as a Supporting Tool for Breast Cancer Patients Using Adjuvant Endocrine Therapy
- ClinicalTrials.gov ID
- NCT05085678
- Acronym / sponsor ID
- G0F9119N
- Conditions
- Breast Cancer, Quality of Life, Self Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- 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 objective of the study is to evaluate the effect of an online tool, based on patient reported outcomes (Co'moon), on the quality of life of breast cancer patients on adjuvant endocrine therapy in the University Hospital Leuven.
Detailed description
The project aims to develop and evaluate an online programme to support patients with breast cancer on adjuvant endocrine therapy in the University Hospital Leuven. The tool "Co'moon" has been developed in the first phase of the project and secondly refine in a pilot study. In the third phase a randomised controlled study investigates the effect of Co'moon in comparison with the standard of care in the University Hospital Leuven. Hereby focussing on the improvement of self-efficacy en quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled trial with convenience sampling
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Standard of care: * a short overview of the physician on adjuvant endocrine therapy * a brochure on adjuvant endocrine therapy * a voluntary group session on adjuvant endocrine therapy and a monthly questionnaire on the patient reported outcomes |
| Intervention group | Experimental | Device: Co'moon (online website to support women with AET)Standard care with the access of to the online tool Co'moon and a monthly questionnaire on patient reported outcomes. The outcome of the questionnaires are summarized for the physician to discuss during the follow-up consultation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Women
- Older than 18 years
- Speaking, understanding and writing Dutch fluently
- Mentally competent
- Recently underwent a operation for breast cancer (invasive or in situ)
Key exclusion criteria (4 listed)
- Different treatments regimes (e.g. adjuvant trial or a combination with cycline-dependent kinase (CDK) 4/6-inhibitors)
- Metastatic disease
- Included in panels
- Member of the research team
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 |
|---|---|---|
| Co'moon (online website to support women with AET)Also: Class 1 medical deviceThe tool contains three parts: 1. e-learning based on the brochure on adjuvant endocrine therapy (AET) in the University Hospital Leuven, 2. serious game where patients are confronted with scenes of their daily life and motivational guidelines to stimulate their self-management, 3. a patient-reported-outcome questionnaire (PROMs), reported in the patient medical file. The tool is designed to stimulate patients self-management of their menopausal AET-related complaints and to discuss them with their health care professionals . | Device | Intervention group |
Primary outcome
Change in quality of Life - FACT-ES - B5 - H18
Time frame: monthly after two months of AET; up to 3 months
Total score of Functional Assessment of Chronic Illness Therapy system of Quality of Life questionnaires of endocrine symptoms (FACT-ES) combined with additional questions B5 and H18. A validated questionnaire with a 5-point Likert scale and a total score of 180 (high QoL).
Change in self-efficacy
Time frame: month 3 and 6 or 7 after the start with AET
patient reported impact on the side effects of AET
Therapy adherence
Time frame: monthly after two months of AET; up to 3 months
patient reported intentional or accidental forgot the medication
Questionnaire on patients experience with the patient-physician relationship
Time frame: month 6 or 7 after the start with AET
patient reported their experience of the follow-up consultation in a 5 point Likert scale questionnaire
Questionnaire on change in patient-relative communication over a period of +/- 3 months
Time frame: month 3 and 6 or 7 after the start with AET
patient reported a change in the communication of patients with their relatives in a 5 point Likert scale questionnaire
3 secondary outcomes
Patient reported outcomes
Time frame: Monthly after two months of AET; up to 3 months
Questionnaire on the experience of the healthcare professional regarding the summary of PRO's
Time frame: month 6 or 7 after the start of AET
Time-spend on Co'moon
Time frame: up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Ines Nevelsteen, Phd principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Co'moon (online website to support women with AET) in people with Breast Cancer and Quality of Life, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 9 inclusion and 4 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: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of Life - FACT-ES - B5 - H18 (time frame: monthly after two months of AET; up to 3 months). The study lists 5 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 28 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.