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Decision Support TechniqueNCT04190992

E-Based Technology to Provide Decision Aid on Breast Reconstruction for Women With Breast Cance

A study testing E-based & personalized breast reconstruction surgery decision aid in people with Decision Support Technique and Breast Cancer, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Using decision aids has been demonstrated to support women to make treatment decision effectively. However, these studies focused on the decision of receiving breast conservative surgery or mastectomy, had short term follow-ups on decision satisfaction.The aims of this study were: Evaluate the effect of E-based \&… Read more about this study

Who is it for?
Ages 20 years and older, women only
Conditions the study is for
Decision Support Technique, Breast Cancer
What is being tested?
E-based & personalized breast reconstruction surgery decision aid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
1 siteTaiwan
Study dates
5 May 2017to 31 Dec 2020
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 20 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age of at least 20 years or under 20 years but married
  • females newly diagnosed with breast cancer who are candidates for mastectomy
  • ability to read and speak Taiwanese or Mandarin

Who cannot join

  • Women with cancer recurrence
  • poor cognitive function
  • diagnosed with psychiatric disease

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Cheng Kung University Hospital

    Tainan

Other trials in Taiwan

About this study

Official title: The Effect of E-Based Technology to Provide Personalized Decision Aid on Breast Reconstruction for Women With Breast Cancer

Using decision aids has been demonstrated to support women to make treatment decision effectively. However, these studies focused on the decision of receiving breast conservative surgery or mastectomy, had short term follow-ups on decision satisfaction.The aims of this study were: Evaluate the effect of E-based \& personalized breast reconstruction surgery decision aid on women's decision satisfaction and mental health.

Read the detailed description

Randomized controlled trial will be used to examine the effect of E-based \& personalized breast reconstruction surgery decision aid on decision satisfaction, body image, anxiety and depression. Participants will be randomly assigned into either experimental or control groups with 88 women in each group. After completing the questionnaires at baseline, participants in the experimental group will be asked to receive a E-based \& personalized breast reconstruction surgery decision aid at clinic. Control group will only receive pamphlet and usual care. All participants will be followed up 1 week after consultation, and 1 month, 8 month and 12 month after surgery.

Being tested
E-based & personalized breast reconstruction surgery decision aid, Usual care
Keywords
Decision aid, Breast reconstruction, E-based Technology
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E-based & personalized breast reconstruction surgery decision aidOther

    Also called APP decision aid

    This decision aid contains information regarding surgical options, including breast reconstruction and mastectomy, such as the advantages and disadvantages, the complication probabilities of each option, a value clarification exercise for the patient's self-evaluation, and a summary of the participant's decision-making process.

  • Usual careOther

    A pamphlet introduce the introduction of types of surgery

Study groups in NCT04190992
Study groupRoleWhat they receive
Application (APP) groupExperimentalAfter completing the questionnaires at baseline, participants in the experimental group will be asked to receive a pamphlet and an E-based \& personalized breast reconstruction surgery decision aid at clinic.
Receives: Other: E-based & personalized breast reconstruction surgery decision aid; Other: Usual care
Usual care groupOtherAfter completing the questionnaires at baseline, participants in the control group will only receive a pamphlet as usual care
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body image

    The Body Image Scale (BIS) has ten items rated on a four-point Likert scale (0 [not at all] to 3 [very much]), with total scores ranging from 0 to 30. Higher scores indicate greater BI distress.

    Measured: Pre-surgery, 1 month, 8 month, 12 month post surgery

  2. Decision Regret

    Decision Regret Scale (DRS) accesses "distress or remorse after a surgery decision". This instrument contains 5 items. The items were summed, divided by 5, and multiplied by 25. Higher scores indicate greater decision regret.

    Measured: 1 month, 8 month, 12 month post surgery

  3. Decision conflict

    Decision Conflict Scale (DCS) accesses the perception of uncertainty in information, values or support for surgery options. This instrument contains 16 items and was developed by O'Connor. The items were summed, divided by 16, and multiplied by 25. Higher scores indicate greater decision conflict.

    Measured: Pre-surgery, 1 week after intervention

Secondary outcomes (3)

  1. Anxiety

    The Hospital Anxiety and Depression Scale (HADS) assesses symptoms of anxiety and depression. The HADS includes 14 items, of which 7 measure anxiety, and 7 measure depression. All items are scored using a 0-3 point scale, with higher scores indicating more depressive symptoms. Cut-off scores are used to categorize anxiety and depressive symptoms, with values of over 8 indicating possible anxiety and depression, and 11 or above indicating probable anxiety.

    Measured: Pre-surgery, 1 month, 8 month, 12 month post surgery

  2. Depression

    The Hospital Anxiety and Depression Scale (HADS) assesses symptoms of anxiety and depression. The HADS includes 14 items, of which 7 measure anxiety, and 7 measure depression. All items are scored using a 0-3 point scale, with higher scores indicating more depressive symptoms. Cut-off scores are used to categorize anxiety and depressive symptoms, with values of over 8 indicating possible anxiety and depression, and 11 or above indicating probable depression.

    Measured: Pre-surgery, 1 month, 8 month, 12 month post surgery

  3. Involvement in the Breast Reconstruction (BR) decision-making process scale

    Involvement in the BR decision-making process was divided into two subscales, one accesses the perception of medical information about surgery obtained with 6 items and the other assesses the perception of partners' involvement in the BR decision-making process with 7 items. The scale used a five-point Likert scale (1 [strongly disagree] to 5 [strongly agree]); the higher the score, the greater the amount of information the participants believed they had obtained and the greater the participants perceived their partner's involvement in the BR decision-making process.

    Measured: 1 week after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2019
  2. Study start5 May 2017
  3. Primary completion25 Jul 2019
  4. Study completion31 Dec 2020 (estimated)

Resources

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
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
176 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04190992
Sponsor's protocol ID
B-ER-106-072
Status last verified
Dec 2019
First submitted
4 Dec 2019
Last updated
9 Dec 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Fang SY, Lin PJ, Kuo YL. Long-Term Effectiveness of a Decision Support App (Pink Journey) for Women Considering Breast Reconstruction Surgery: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Dec 10;9(12):e31092. doi: 10.2196/31092.

    PubMed 34890354

Questions about this trial

What is this clinical trial studying?

A study testing E-based & personalized breast reconstruction surgery decision aid in people with Decision Support Technique and Breast Cancer, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

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 3 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 9 Dec 2019. 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 Taiwan. 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?

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?

Body image (time frame: Pre-surgery, 1 month, 8 month, 12 month post surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04190992, which also lists 1 linked publication.

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 9 Dec 2019.

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