Breast CancerNCT02488603
Decision Aids for Tamoxifen Treatment in Breast Cancer Patients
A study testing Decision aids (tamoxifen-related educational materials in brochure or mobile app) and tamoxifen in people with Breast Cancer, run by National Cancer Center, Korea.
Trial summary
This is an educational intervention study for breast cancer patients who undergo tamoxifen treatment. The purpose of the study is to assess the impact of decision aids (DA) on the patients' decision-making process, compliance on drug, and knowledge regarding tamoxifen treatment. 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
- What is being tested?
- Decision aids (tamoxifen-related educational materials in brochure or mobile app) and tamoxifen
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Aug 2018
- 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
- Breast cancer patients who are recommended to undergo tamoxifen treatment in National Cancer Center, Korea
- - Age at least 18 years and more
Who cannot join
- Age under 18 years
- Inability to read or speak Korean
- Disagree to provide a written informed consent
About this study
Official title: Utilization of Decision Aids for Tamoxifen Treatment in Breast Cancer Patients: A Randomized Controlled Trial.
This is an educational intervention study for breast cancer patients who undergo tamoxifen treatment. The purpose of the study is to assess the impact of decision aids (DA) on the patients' decision-making process, compliance on drug, and knowledge regarding tamoxifen treatment. Patients will randomly assign to DA group or conventional group. Both groups will have baseline questionnaire surveys before starting tamoxifen treatment, and 4 weeks later follow-up questionnaire surveys.
- Conditions
- Breast Cancer
- Being tested
- Decision aids (tamoxifen-related educational materials in brochure or mobile app), tamoxifen
- Keywords
- Breast Neoplasms, Tamoxifen, Decision Aids
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision aids (tamoxifen-related educational materials in brochure or mobile app)Behavioural
Decision aids (tamoxifen-related educational materials in brochure or mobile app)
tamoxifenDrug
| Study group | Role | What they receive |
|---|---|---|
| Decision aids | Experimental | Not described Receives: Behavioral: Decision aids (tamoxifen-related educational materials in brochure or mobile app); Drug: tamoxifen |
| usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knowledge of Tamoxifen Scale
Measured: baseline, 4weeks later
Secondary outcomes (4)
Decisional Conflict Scale
Assess the decisional conflict regarding tamoxifen treatment
Measured: baseline, 4weeks later
Satisfaction with Decision Questionnaire
Assess the satisfaction with decision to undergo tamoxifen treatment
Measured: baseline, 4weeks later
EORTC QLQ-C30 Questionnaire
Assess the quality of life before and during tamoxfen treatment
Measured: baseline, 4weeks later
EQ-5D Questionnaire
Assess the quality of life before and during tamoxfen treatment
Measured: baseline, 4weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2018 (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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eun Sook Lee, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488603
- Sponsor's protocol ID
- NCCKorea
- Status last verified
- Jun 2015
- First submitted
- 25 Jun 2015
- Last updated
- 2 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Decision Aids for Tamoxifen Treatment in Breast Cancer Patients: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02488603
- Acronym / sponsor ID
- NCCKorea
- Conditions
- Breast Cancer
- Keywords
- Breast Neoplasms, Tamoxifen, Decision Aids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Aug 2015
- Primary completion
- Aug 2018 (estimated)
- First posted
- 2 Jul 2015 (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.
This is an educational intervention study for breast cancer patients who undergo tamoxifen treatment. The purpose of the study is to assess the impact of decision aids (DA) on the patients' decision-making process, compliance on drug, and knowledge regarding tamoxifen treatment. Patients will randomly assign to DA group or conventional group. Both groups will have baseline questionnaire surveys before starting tamoxifen treatment, and 4 weeks later follow-up questionnaire surveys.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision aids | Experimental | Behavioral: Decision aids (tamoxifen-related educational materials in brochure or mobile app), Drug: tamoxifen |
| usual care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Breast cancer patients who are recommended to undergo tamoxifen treatment in National Cancer Center, Korea
- - Age at least 18 years and more
Key exclusion criteria (3 listed)
- Age under 18 years
- Inability to read or speak Korean
- Disagree to provide a written informed consent
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 |
|---|---|---|
| Decision aids (tamoxifen-related educational materials in brochure or mobile app)Decision aids (tamoxifen-related educational materials in brochure or mobile app) | Behavioural | Decision aids |
| tamoxifen | Drug | Decision aids |
Primary outcome
Change in Knowledge of Tamoxifen Scale
Time frame: baseline, 4weeks later
4 secondary outcomes
Decisional Conflict Scale
Time frame: baseline, 4weeks later
Satisfaction with Decision Questionnaire
Time frame: baseline, 4weeks later
EORTC QLQ-C30 Questionnaire
Time frame: baseline, 4weeks later
EQ-5D Questionnaire
Time frame: baseline, 4weeks later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Decision aids (tamoxifen-related educational materials in brochure or mobile app) and tamoxifen in people with Breast Cancer, run by National Cancer Center, Korea.
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 2 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Knowledge of Tamoxifen Scale (time frame: baseline, 4weeks later). 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 2 Jul 2015.