Breast CancerENCOURAGENCT01834521
Web-based Screening and Tailored Support
A study testing Web-based screening and tailored support in people with Breast Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The ever expanding breast cancer survivor population urges the health care system to develop (cost-)effective screening and management of convalescent care needs that can be easily implemented in conventional follow-up care. Internet-delivered systems may be well-equipped to meet these demands. 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?
- Web-based screening and tailored support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2013to Dec 2014
- 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
- Adult female breast cancer patients (aged ≥ 18 years of age).
- Recent completion (≤6 months) of (neo)adjuvant chemotherapy for primary breast cancer
- Ability to comprehend Dutch (both reading and writing).
- Access to internet (e.g. at home, via family or friends)
- Informed consent provided
Who cannot join
- Chemotherapy treatment with palliative intent or recurrent breast cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Web-based Screening and Tailored Support for Breast Cancer Patients at the Onset of the Survivorship Phase
The ever expanding breast cancer survivor population urges the health care system to develop (cost-)effective screening and management of convalescent care needs that can be easily implemented in conventional follow-up care. Internet-delivered systems may be well-equipped to meet these demands. The aim of the current study is to assess the effectiveness of a web-based support system. Key features of this system are patient self-screening of physical and psychosocial problems, tailored patient education on reported problems and self-referral to professional care. In this era of high internet usage, we expect that internet is a highly suitable medium to provide tailored support for breast cancer patients and will empower the patient to take control over their convalescence.
- Conditions
- Breast Cancer
- Being tested
- Web-based screening and tailored support
- Keywords
- Breast cancer, psychosocial, website, empowerment
- Medical subject headings
- Breast Neoplasms, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based screening and tailored supportOther
| Study group | Role | What they receive |
|---|---|---|
| Web-based screening and tailored support | Experimental | A personalized website (username/password) will become available to patients assigned to the intervention arm for 12 subsequent weeks. Key features of the website are self-screening, tailored patient education and self-referral. Self-screening will be performed by an online version of the Dutch Distress thermometer (DT) and Problem List (PL). Patients will receive digital feedback on their DT score immediately after test completion together with information regarding problems reported on the PL, (self)help options and possibilities for referral to professional care. Contact information of one of the investigators will also be available to discuss questions, problems and/or referral needs. Patients may also request a telephone call. Receives: Other: Web-based screening and tailored support |
| Standard care | No intervention | Patients assigned to standard convalescent care will receive the usual follow-up care delivered by their treating oncologists. Patients will be referred to psychosocial or allied care by their oncologist and/or oncology nurse if certain physical and/or psychosocial problems require more in-depth professional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from 6 to 12 weeks follow-up in optimism and control over the future
Patients' optimism and control over the future will be measured by the subscale 'increased optimism and control over the future' of the 'Constructs Empowering Outcomes Questionnaire'. The subscale 'optimism and control over the future' represents a single concept/outcome measure. The concept cannot be assessed at baseline due to the retrospective nature of the questionnaire.
Measured: 6 and 12 weeks
Secondary outcomes (4)
Change from 6 to 12 weeks follow-up in knowledge level
Patient knowledge level will be measured by the subscale 'being better informed' of the 'Constructs Empowering Outcomes Questionnaire'. The concept cannot be assessed at baseline due to the retrospective nature of the questionnaire.
Measured: 6 and 12 weeks
Change from 6 weeks to 12 weeks follow-up in acceptance of problems
Patients' acceptance of their problems will be measured by the subscale 'improved acceptance of the illness' of the 'Constructs Empowering Outcomes Questionnaire'. The concept cannot be assessed at baseline due to the retrospective nature of the questionnaire.
Measured: 6 and 12 weeks
Change from baseline to 12 weeks follow-up in quality of life
Cancer-specific quality of life will be measured by the EORTC QLQ-C30 (version 3.0) questionnaire.
Measured: Baseline and 12 weeks follow-up
Change from baseline to 12 weeks follow-up in psychological distress
Psychological distress will be measured by the Dutch Distress Thermometer and Problem List.
Measured: Baseline and 12 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionDec 2014
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
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- A.K.L. Reyners, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834521
- Sponsor's protocol ID
- ENCOURAGE2-2012
- Other IDs
- NL41408.042.12
- Acronym
- ENCOURAGE
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2013
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Screening and Tailored Support for Breast Cancer Patients at the Onset of the Survivorship Phase
- ClinicalTrials.gov ID
- NCT01834521
- Acronym / sponsor ID
- ENCOURAGE / ENCOURAGE2-2012
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, psychosocial, website, empowerment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Apr 2013 (estimated)
- 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 ever expanding breast cancer survivor population urges the health care system to develop (cost-)effective screening and management of convalescent care needs that can be easily implemented in conventional follow-up care. Internet-delivered systems may be well-equipped to meet these demands. The aim of the current study is to assess the effectiveness of a web-based support system. Key features of this system are patient self-screening of physical and psychosocial problems, tailored patient education on reported problems and self-referral to professional care. In this era of high internet usage, we expect that internet is a highly suitable medium to provide tailored support for breast cancer patients and will empower the patient to take control over their convalescence.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based screening and tailored support | Experimental | Other: Web-based screening and tailored supportA personalized website (username/password) will become available to patients assigned to the intervention arm for 12 subsequent weeks. Key features of the website are self-screening, tailored patient education and self-referral. Self-screening will be performed by an online version of the Dutch Distress thermometer (DT) and Problem List (PL). Patients will receive digital feedback on their DT score immediately after test completion together with information regarding problems reported on the PL, (self)help options and possibilities for referral to professional care. Contact information of one of the investigators will also be available to discuss questions, problems and/or referral needs. Patients may also request a telephone call. |
| Standard care | No intervention | –Patients assigned to standard convalescent care will receive the usual follow-up care delivered by their treating oncologists. Patients will be referred to psychosocial or allied care by their oncologist and/or oncology nurse if certain physical and/or psychosocial problems require more in-depth professional care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult female breast cancer patients (aged ≥ 18 years of age).
- Recent completion (≤6 months) of (neo)adjuvant chemotherapy for primary breast cancer
- Ability to comprehend Dutch (both reading and writing).
- Access to internet (e.g. at home, via family or friends)
- Informed consent provided
Key exclusion criteria (1 listed)
- Chemotherapy treatment with palliative intent or recurrent breast cancer
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 |
|---|---|---|
| Web-based screening and tailored support | Other | Web-based screening and tailored support |
Primary outcome
Change from 6 to 12 weeks follow-up in optimism and control over the future
Time frame: 6 and 12 weeks
Patients' optimism and control over the future will be measured by the subscale 'increased optimism and control over the future' of the 'Constructs Empowering Outcomes Questionnaire'. The subscale 'optimism and control over the future' represents a single concept/outcome measure. The concept cannot be assessed at baseline due to the retrospective nature of the questionnaire.
4 secondary outcomes
Change from 6 to 12 weeks follow-up in knowledge level
Time frame: 6 and 12 weeks
Change from 6 weeks to 12 weeks follow-up in acceptance of problems
Time frame: 6 and 12 weeks
Change from baseline to 12 weeks follow-up in quality of life
Time frame: Baseline and 12 weeks follow-up
Change from baseline to 12 weeks follow-up in psychological distress
Time frame: Baseline and 12 weeks follow-up
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 19 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.
A.K.L. Reyners, MD, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based screening and tailored support in people with Breast Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
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 5 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 19 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 1 site in Netherlands. 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 from 6 to 12 weeks follow-up in optimism and control over the future (time frame: 6 and 12 weeks). 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 19 Apr 2024.