AzTrials
AzTrials

Breast CancerDSWNCT01857882

Decision Support Workshop for Breast Reconstruction

A study testing Decision Support Workshop in people with Breast Cancer, run by University Health Network, Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the effectiveness of a pre-consultation decision support workshop for breast reconstruction after breast cancer, in facilitating the decision-making process, compared to routine pre-surgical education. Read more about this study

Who is it for?
Ages 18 to 79 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Decision Support Workshop
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteCanada
Study dates
Sep 2012to Jul 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 79 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient age: 18 - 79 years at the time of consultation
  • In situ or invasive biopsy confirmed breast adenocarcinoma
  • Considered for immediate or delayed breast reconstruction
  • First consultation for breast reconstruction

Who cannot join

  • Chest wall or atypical breast malignancy (ex: angiosarcoma) or inflammatory adenocarcinoma of the breast
  • Completion any phase of reconstruction, or for revision reconstruction
  • Patient cannot read or write in English.
  • Cognitive impairment or uncontrolled psychiatric diagnosis

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

Other trials in Canada

About this study

Official title: Breast Reconstruction Decision Workshop Pilot RCT (Randomized Controlled Trial)

The purpose of this study is to determine the effectiveness of a pre-consultation decision support workshop for breast reconstruction after breast cancer, in facilitating the decision-making process, compared to routine pre-surgical education.

Read the detailed description

Postmastectomy breast reconstruction is becoming increasingly utilized in breast cancer patients to provide surgical restoration of the breast mounds. The breast reconstruction discussions can be highly complex, as there are many different techniques, timing, and complications that are unique to each procedure. However ¼ of women report being dissatisfied with some component of their cancer or reconstructive care. Failure of the physician to provide adequate information about treatment options is the most frequent source of cancer patient dissatisfaction and breast reconstruction patients have expressed a need for further information regarding the complex decision to pursue breast reconstruction. In such scenarios of complex medical decision-making, decision support techniques may be an effective solution to information provision and shared decision-making. As a result, the investigators developed a pre-consultation educational group intervention delivered in a group setting for women considering breast reconstruction, with the aims to fill an existing information-gap, promote high-quality decision-making and enhance decision self-efficacy and other decision measures. This pilot study will be the first step in the evaluation of the educational group intervention and the results will be used to determine the feasibility and inform the optimal design for a definitive randomized controlled trial. This study will first examine the feasibility and acceptability of the intervention through implementation in a pilot, mixed-methods, 1:1 allocation parallel-arm randomized controlled trial.

Conditions
Breast Cancer
Being tested
Decision Support Workshop
Keywords
breast cancer, breast reconstruction, shared decision making, decision support intervention
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 Support WorkshopOther

    Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.

    • Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities
    • Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system
    • Social worker (30 mins): values clarification exercise
    • Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience
Study groups in NCT01857882
Study groupRoleWhat they receive
Decision Support WorkshopExperimentalThe decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.
Receives: Other: Decision Support Workshop
Standard CareNo interventionRoutine pre-consultation education

What is being measured

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

  1. Decision Self-efficacy Scale

    Decision self-efficacy (DSE) scale is a prospectively designed instrument to evaluate patient self-confidence in decision-making, including shared decision-making. It has been validated among women facing treatment decisions for osteoporosis and used in cancer patients. Psychometric evaluation has shown high levels of internal consistency (Cronbach alpha 0.90). Decision self-efficacy is correlated with decision conflict subscales of feeling informed (r = 0.47) and supported (r = 0.45). This instrument has never been tested in the breast cancer or breast reconstruction population.

    The total score is calculated by summing the 11 items, dividing by 11 and multiplying by 25. Scores range from 0 (extremely low self-efficacy) to 100 (extremely high self-efficacy).

    The mean and standard deviation (SD) were calculated at baseline and after the initial consultation. Change in score was defined as the difference in total score between baseline and after consultation.

    Measured: Change from baseline decision self-efficacy at 1 week after surgical consultation

Secondary outcomes (10)

  1. Decision Conflict Scale

    Decision conflict scale measures personal perceptions of uncertainty in choosing options and has been demonstrated to be valid and responsive to change. The decisional conflict scale is a 16-item 5-response instrument that reports a score from 0 - 100 with higher scores indicating more conflict (items are summed, divided by 16 and multiplied by 25).

    Measured: Change from baseline decision conflict at 1 week after surgical consultation

  2. Decision Preference and Decision Choice

    Decision Preference and Decision Choice has been used as a primary and secondary outcome in studies of decision support interventions in cancer patients. It demonstrates good test-retest reliability (test-retest coefficient > 0.90) and is sensitive to change when measured before and after an intervention.

    Measured: baseline

  3. Patient Involvement in Care Scale (PICS)

    PICS is a measure of patient perception of involvement with her care, and has seven 5-point Likert scale items that assess the extent to which the patient asked questions, offered opinions, and expressed concerns when meeting with the surgeon.

    Measured: T1 (1 week after surgical consultation)

  4. Satisfaction With Information (Sub-scale of BREAST-Q)

    The BREAST-Q is a procedure-specific and validated PRO that measures Hr-QOL and patient satisfaction with breast reconstruction. The "Satisfaction with Information" Subscale specifically measures patient satisfaction with the preoperative information and care provided by the plastic surgeon and other members of the medical team. There are 15 items that use a four-level Likert scale response format, the score is transformed on a scale of 0 to 100 with higher scores indicating greater satisfaction.

    Measured: T1 (1 week after surgical consultation)

  5. Qualitative Interview Assessment

    A subgroup of participants allocated to both the experimental and usual care groups will be asked to participate in a brief qualitative telephone interview. Purposeful sampling will be used to recruit 5 patients from each group to achieve data saturation and variability. Telephone interviews will be conducted by a social worker trained in qualitative methods. All participants randomized to the workshop will additionally be asked to complete a written survey for evaluation of the intervention immediately after participation in the workshop.

    Measured: Within three months after initial consultation

  6. Uptake Rate of Breast Reconstruction-Service Outcome

    The uptake rate of breast reconstruction (if patients chose breast reconstruction or no reconstruction)

    Measured: Six months after initial consultation

  7. Length of Consultation-service Outcome

    The length of the initial consultation with the plastic surgeon, measured in minutes. Consultations are expected to be between 20-60 mins.

    Measured: Duration of initial consultation

  8. Number of Consultations-service Outcomes

    The number of consultations with the plastic surgeon until the patient has made a reconstruction choice (defined as signing a surgical consent form) will be recorded. Patients can spend months considering their choices, so it is appropriate to follow them for a period of at least six months after their initial consultation.

    Measured: Six months after initial consultation

  9. Breast Reconstruction Knowledge Test

    This breast reconstruction knowledge test is a 12-item 3-response questionnaire that records the score on a continuous integer scale, and measured patient's knowledge regarding breast reconstruction.

    Measured: Change in baseline breast reconstruction knowledge at 1 week after initial consultation

  10. Medical Outcomes Study Social Support Survey

    Medical Outcomes Study Social Support Survey has a series of 18 questions that measure 4 domains of social support (emotional, tangible, affectionate, and social interactions). Responses range from 1 (none of the time) to 5 (all the time). The items in each domain were summed and then transformed to yield scores ranging from 0 to 100. Higher scores indicate more support.

    Measured: baseline

Timeline

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

  1. First posted20 May 2013 (estimated)
  2. Study startSep 2012
  3. Primary completionJul 2013
  4. Study completionJul 2013

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
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01857882
Sponsor's protocol ID
11-1027-CE
Acronym
DSW
Status last verified
Jun 2015
First submitted
6 May 2013
Last updated
17 Jun 2015
Data monitoring committee
No

Publications

  • Causarano N, Platt J, Baxter NN, Bagher S, Jones JM, Metcalfe KA, Hofer SO, O'Neill AC, Cheng T, Starenkyj E, Zhong T. Pre-consultation educational group intervention to improve shared decision-making for postmastectomy breast reconstruction: a pilot randomized controlled trial. Support Care Cancer. 2015 May;23(5):1365-75. doi: 10.1007/s00520-014-2479-6. Epub 2014 Oct 29.

    PubMed 25351455

  • Platt J, Baxter N, Jones J, Metcalfe K, Causarano N, Hofer SO, O'Neill A, Cheng T, Starenkyj E, Zhong T. Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial. Trials. 2013 Jul 6;14:199. doi: 10.1186/1745-6215-14-199.

    PubMed 23829442

Questions about this trial

What is this clinical trial studying?

A study testing Decision Support Workshop in people with Breast Cancer, run by University Health Network, Toronto at 1 site in Canada.

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 4 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 17 Jun 2015. 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 Canada. 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?

Yes. Results are posted in the registry (first posted 17 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Decision Self-efficacy Scale (time frame: Change from baseline decision self-efficacy at 1 week after surgical consultation). 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 NCT01857882, which also lists 2 linked publications.

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 17 Jun 2015.

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Decision Support Workshop for Breast Reconstruction | AzTrials