Breast CancerNCT04745117
Health Technologies Readiness in Breast Cancer Patients
An observational study of Breast Cancer, run by Odense University Hospital at 1 site in Denmark.
Trial summary
This study aims to investigate the degree of Health Technologies Readiness amongst patients with suspected breast cancer using the READHY-tool. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- READHY - questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2021to 31 Aug 2021
- Phase
- Observational
- 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
Study population: All women referred to the Breast Cancer Center at Odense University Hospital under the suspicion of breast cancer.
Who may be able to join
- All patients referred to our department with suspected breast cancer.
- Ability to understand the aim of the study and to give consent. Being able to understand Danish at the level required to answer the questionnaires.
Who cannot join
- Danish skills that are insufficient for understanding and filling out the READHY-questionnaire in Danish.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Degree of Health Technologies Readiness Amongst Patients With Suspected Breast Cancer Using the READHY-tool
This study aims to investigate the degree of Health Technologies Readiness amongst patients with suspected breast cancer using the READHY-tool.
Read the detailed description
Health information, patient education, and self-management (health information and advice) tools are increasingly being made available to adults with different health conditions, either through internet-based health and mobile health digital information technologies (1). At the department of plastic surgery, there has, for several years, been a transition to digital solutions when delivering information to patients. Patient information now consists of web-sites, apps and videos available for the patients to use when they seek information about their disease and their treatment options. From a care-givers perspective, the increased amount of information available is positive, but can these patients cope with so much information being available digitally instead of information face-to-face or by paper? Despite the rapid change from analogue informatics to digital solutions, we do not know a lot about our patients' readiness for such a change. There is an increasing amount of studies on the subject, but no recent study on readiness for digital solutions among this patient group, patients with suspected breast cancer. That is what this study is hoping to achieve with this study. The plan is to use a relatively new tool called "READHY" to assess the health technology readiness amongst breast cancer patients. The tool consists of 70 questions, and the results will enable grouping of these patients according to their health technology readiness.
This study is a cross-sectional study where participants fill out a single questionnaire at first contact with the out-patient clinic. There will not be any follow-up.
The project is planned to start at 01.03.2021 and run for six months with termination at 30.09.21.
A clinical statistician was consulted regarding power and sample size. No power analysis was performed due to the nature of the study. In accordance with previous studies with similar methods, a convenience sample was chosen. 250 participants will be included over six consecutive months (2,3).
All patient-reported data will be handled through the secure server solution provided by OPEN Region of Southern Denmark. Additional data will be kept in the secure server Sharepoint, provided by Odense University Hospital.
The project complies with The General Data Protection Regulation act (databeskyttelsesforordningen) and the Danish Data Protection act (databeskyttelsesloven).
The study is in line with the Helsinki-declaration. Participation is by individuals capable of giving informed consent.
There are no personal gains for our participants, but in the longer perspective, the information gathered will enable physicians to better understand the eHealth literacy in this patient group. This will, in turn, help to improve the way the patients arre informed about their disease, treatment and options.
- Conditions
- Breast Cancer
- Being tested
- READHY - questionnaire
- Keywords
- Health Technology Readiness
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
READHY - questionnaireBehavioural
The READHY tool consists of 70 questions divided into three sections, one with a focus on eHealth literacy, one on self-management and one on the social context. The READHY consists of the eHealth Literacy Questionnaire (eHLQ) that includes seven scales, supplemented with four scales from the Health Education Impact Questionnaire (heiQ) and two scales from the Health Literacy Questionnaire (HLQ). The READHY tool has been validated. Each question presented to the participant as a statement and scored on a 4-point rating, from 1=strongly disagree to 4=strongly agree. The overall score of each scale was calculated as the mean score of the 4-6 items (i.e., statements) that constitute the scale (2).
| Study group | Role | What they receive |
|---|---|---|
| Women with suspected breast cancer | All women referred under the diagnosis "suspected breast cancer" will be asked to fill out the questionnaire "READHY". Receives: Behavioral: READHY - questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of the Readiness and Enablement Index for Health Technology (READHY)
All participants will have a READHY-score calculated. Score ranges from 1-4. A higher score indicates a higher degree of health technology readiness.
Measured: 1 month
Grouping using (Readiness and Enablement Index for Health Technology) READHY-scores
Using the results of the whole cohort, cluster analysis will be applied to group the participants into groups on levels of health technology readiness. Score ranges from 1-4. A higher score indicates a higher degree of health technology readiness.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Mar 2021
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
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 Odense University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Sollie, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745117
- Sponsor's protocol ID
- 21/4657
- Status last verified
- Mar 2023
- First submitted
- 4 Feb 2021
- Last updated
- 22 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 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Degree of Health Technologies Readiness Amongst Patients With Suspected Breast Cancer Using the READHY-tool
- ClinicalTrials.gov ID
- NCT04745117
- Acronym / sponsor ID
- 21/4657
- Conditions
- Breast Cancer
- Keywords
- Health Technology Readiness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 9 Feb 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.
This study aims to investigate the degree of Health Technologies Readiness amongst patients with suspected breast cancer using the READHY-tool.
Detailed description
Health information, patient education, and self-management (health information and advice) tools are increasingly being made available to adults with different health conditions, either through internet-based health and mobile health digital information technologies (1). At the department of plastic surgery, there has, for several years, been a transition to digital solutions when delivering information to patients. Patient information now consists of web-sites, apps and videos available for the patients to use when they seek information about their disease and their treatment options. From a care-givers perspective, the increased amount of information available is positive, but can these patients cope with so much information being available digitally instead of information face-to-face or by paper? Despite the rapid change from analogue informatics to digital solutions, we do not know a lot about our patients' readiness for such a change. There is an increasing amount of studies on the subject, but no recent study on readiness for digital solutions among this patient group, patients with suspected breast cancer. That is what this study is hoping to achieve with this study. The plan is to use a relatively new tool called "READHY" to assess the health technology readiness amongst breast cancer patients. The tool consists of 70 questions, and the results will enable grouping of these patients according to their health technology readiness.
This study is a cross-sectional study where participants fill out a single questionnaire at first contact with the out-patient clinic. There will not be any follow-up.
The project is planned to start at 01.03.2021 and run for six months with termination at 30.09.21.
A clinical statistician was consulted regarding power and sample size. No power analysis was performed due to the nature of the study. In accordance with previous studies with similar methods, a convenience sample was chosen. 250 participants will be included over six consecutive months (2,3).
All patient-reported data will be handled through the secure server solution provided by OPEN Region of Southern Denmark. Additional data will be kept in the secure server Sharepoint, provided by Odense University Hospital.
The project complies with The General Data Protection Regulation act (databeskyttelsesforordningen) and the Danish Data Protection act (databeskyttelsesloven).
The study is in line with the Helsinki-declaration. Participation is by individuals capable of giving informed consent.
There are no personal gains for our participants, but in the longer perspective, the information gathered will enable physicians to better understand the eHealth literacy in this patient group. This will, in turn, help to improve the way the patients arre informed about their disease, treatment and options.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with suspected breast cancer | – | Behavioral: READHY - questionnaireAll women referred under the diagnosis "suspected breast cancer" will be asked to fill out the questionnaire "READHY". |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All women referred to the Breast Cancer Center at Odense University Hospital under the suspicion of breast cancer.
Key inclusion criteria (2 listed)
- All patients referred to our department with suspected breast cancer.
- Ability to understand the aim of the study and to give consent. Being able to understand Danish at the level required to answer the questionnaires.
Key exclusion criteria (1 listed)
- Danish skills that are insufficient for understanding and filling out the READHY-questionnaire in Danish.
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 |
|---|---|---|
| READHY - questionnaireThe READHY tool consists of 70 questions divided into three sections, one with a focus on eHealth literacy, one on self-management and one on the social context. The READHY consists of the eHealth Literacy Questionnaire (eHLQ) that includes seven scales, supplemented with four scales from the Health Education Impact Questionnaire (heiQ) and two scales from the Health Literacy Questionnaire (HLQ). The READHY tool has been validated. Each question presented to the participant as a statement and scored on a 4-point rating, from 1=strongly disagree to 4=strongly agree. The overall score of each scale was calculated as the mean score of the 4-6 items (i.e., statements) that constitute the scale (2). | Behavioural | Women with suspected breast cancer |
Primary outcome
Results of the Readiness and Enablement Index for Health Technology (READHY)
Time frame: 1 month
All participants will have a READHY-score calculated. Score ranges from 1-4. A higher score indicates a higher degree of health technology readiness.
Grouping using (Readiness and Enablement Index for Health Technology) READHY-scores
Time frame: 6 months
Using the results of the whole cohort, cluster analysis will be applied to group the participants into groups on levels of health technology readiness. Score ranges from 1-4. A higher score indicates a higher degree of health technology readiness.
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 22 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Odense University Hospital at 1 site in Denmark.
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 1 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 22 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 Denmark. 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?
Results of the Readiness and Enablement Index for Health Technology (READHY) (time frame: 1 month). 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 22 Mar 2023.