Breast CancerBRDANCT01951534
Decisional Aid Intervention for Women Considering Breast Reconstruction
A study testing Breast Reconstruction Decisional Aid (BRDA) in people with Breast Cancer, run by Rutgers, The State University of New Jersey at 9 sites in United States.
Trial summary
This is an intervention development and pilot study whose purpose is to determine the feasibility and acceptability of the breast reconstruction decisional aid (BRDA) and provide preliminary data on its impact on decisional outcomes. 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?
- Breast Reconstruction Decisional Aid (BRDA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 9 sitesUnited States
- Study dates
- Jan 2011to 7 Jun 2016
- 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
- Patient is scheduled for a surgical consult with a breast surgeon
- Primary diagnosis of Stage 0 (Ductal Carcinoma in situ), 1, 2, or 3a breast cancer
- Patient speaks and reads English
- Patient is considering mastectomy
Who cannot join
- Patient who selects lumpectomy and not mastectomy
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Ocean Medical Center
Brick, New Jersey, 08742
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103
Bayshore Community Hospital
Holmdel, New Jersey, 07733
Southern Ocean Medical Center
Manahawkin, New Jersey, 08050
Jersey Shore University Medical Center
Neptune City, New Jersey, 07754
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Riverview Medical Center
Red Bank, New Jersey, 07701
Somerset Medical Center
Somerville, New Jersey
About this study
This is an intervention development and pilot study whose purpose is to determine the feasibility and acceptability of the breast reconstruction decisional aid (BRDA) and provide preliminary data on its impact on decisional outcomes.
The primary aim of this study is: "Is the intervention trial feasible?" The purpose is to develop a feasible web-based decisional aid (DA) for a larger scale trial. Thus it is important that this trial provide evidence of feasibility. The investigators will define feasibility as the rate of study acceptance and participation.
Read more
The secondary aim of this study is: " Is the BRDA acceptable and used?" The team will evaluate BRDA acceptability, use, difficulty with internet use, and what factors predict uptake and use. The investigators anticipate that, due to interest in the topic, the majority of women will access the website.
An additional secondary aim of this study is: "What is the impact of BRDA on BR knowledge, attitudes about BR, decisional conflict, preparedness and completeness of preparation, anxiety, and discussion with oncologist?" The purpose is to calculate effect sizes for a larger randomized trial.
- Conditions
- Breast Cancer
- Being tested
- Breast Reconstruction Decisional Aid (BRDA), Usual Care
- Keywords
- breast reconstruction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Reconstruction Decisional Aid (BRDA)Behavioural
Usual CareBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Breast Reconstruction Decisional Aid (BRDA) | Experimental | In the BRDA arm, participants will be provided with a website address for using the Breast Reconstruction Decisional Aid, a secure password, and instructions for using the website for the decisional aid. Receives: Behavioral: Breast Reconstruction Decisional Aid (BRDA) |
| Usual Care (UC) | Other | In the UC Condition, the participant will not be given the web-based decisional aid but will be given the Cancer Support Community pamphlet. This 56-page pamphlet contains information about the types of Breast Reconstruction, lists reasons why women choose reconstruction, key factors to considering when deciding, how to plan for surgery, possible risks, and a glossary of terms. The pamphlet is primarily informational. It is not customized, not interactive. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of a decisional aid to assist women with making the decision to undergo breast reconstruction
We will define feasibility as the rate of study acceptance and participation. First, we will examine acceptance as determined by consents and completed baselines. Second, we will examine time for completing surveys. We will judge this trial feasible if: 1) the acceptance rate among eligible patients is equal to or greater than 70%. We will judge completion rates at follow-up to be feasible for a larger scale trial if our completion rate is 75%. 2) If the survey length averages are > 35 minutes, we will deem this unacceptable and shorten the survey.
Measured: 3 years
Secondary outcomes (2)
Acceptability of BRDA
We will define acceptability using both quantitative and qualitative methods. Basic descriptive information will be automatically gathered from the DA tracking system regarding whether participants logged in, how many times, and for how long. Time spent in each module will be tracked and summarized. Participants will rate the DA and provide interview feedback regarding its ease of use. Interview feedback regarding home versus public access will be gathered. A second indicator of acceptability will be ratings on the DA evaluation and interview. The range of items on the scale is 1-7. An item mean of 4 is mid-range. We judge our intervention as acceptable if 75% of BRDA participants used the DA and if the average score on the evaluation was > 5.6, which is 80% of the highest score.
Measured: 3 years
Impact of breast reconstruction decisional aid on knowledge and attitudes
This is an exploratory objective to calculate effect sizes for a larger randomized trial. Using survey data that we will collect as part of this research, we will look at the impact of BRDA on knowledge and attitudes.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study startJan 2011
- Primary completion30 Jun 2015
- Study completion7 Jun 2016
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 Rutgers, The State University of New JerseyThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
- Responsible party
- Sponsor
- Investigators
- Sharon Manne, PhD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951534
- Sponsor's protocol ID
- 131025
- Other IDs
- R21CA149531-01A1
- Acronym
- BRDA
- Status last verified
- Jan 2017
- First submitted
- 7 May 2013
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decisional Aid Intervention for Women Considering Breast Reconstruction
- ClinicalTrials.gov ID
- NCT01951534
- Acronym / sponsor ID
- BRDA / 131025
- Conditions
- Breast Cancer
- Keywords
- breast reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
- Study start
- Jan 2011
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 7 Jun 2016 (actual)
- First posted
- 26 Sep 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.
This is an intervention development and pilot study whose purpose is to determine the feasibility and acceptability of the breast reconstruction decisional aid (BRDA) and provide preliminary data on its impact on decisional outcomes.
The primary aim of this study is: "Is the intervention trial feasible?" The purpose is to develop a feasible web-based decisional aid (DA) for a larger scale trial. Thus it is important that this trial provide evidence of feasibility. The investigators will define feasibility as the rate of study acceptance and participation.
The secondary aim of this study is: " Is the BRDA acceptable and used?" The team will evaluate BRDA acceptability, use, difficulty with internet use, and what factors predict uptake and use. The investigators anticipate that, due to interest in the topic, the majority of women will access the website.
An additional secondary aim of this study is: "What is the impact of BRDA on BR knowledge, attitudes about BR, decisional conflict, preparedness and completeness of preparation, anxiety, and discussion with oncologist?" The purpose is to calculate effect sizes for a larger randomized trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Reconstruction Decisional Aid (BRDA) | Experimental | Behavioral: Breast Reconstruction Decisional Aid (BRDA)In the BRDA arm, participants will be provided with a website address for using the Breast Reconstruction Decisional Aid, a secure password, and instructions for using the website for the decisional aid. |
| Usual Care (UC) | Other | Behavioral: Usual CareIn the UC Condition, the participant will not be given the web-based decisional aid but will be given the Cancer Support Community pamphlet. This 56-page pamphlet contains information about the types of Breast Reconstruction, lists reasons why women choose reconstruction, key factors to considering when deciding, how to plan for surgery, possible risks, and a glossary of terms. The pamphlet is primarily informational. It is not customized, not interactive. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is scheduled for a surgical consult with a breast surgeon
- Primary diagnosis of Stage 0 (Ductal Carcinoma in situ), 1, 2, or 3a breast cancer
- Patient speaks and reads English
- Patient is considering mastectomy
Key exclusion criteria (1 listed)
- Patient who selects lumpectomy and not mastectomy
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 |
|---|---|---|
| Breast Reconstruction Decisional Aid (BRDA) | Behavioural | Breast Reconstruction Decisional Aid (BRDA) |
| Usual Care | Behavioural | Usual Care (UC) |
Primary outcome
Feasibility of a decisional aid to assist women with making the decision to undergo breast reconstruction
Time frame: 3 years
We will define feasibility as the rate of study acceptance and participation. First, we will examine acceptance as determined by consents and completed baselines. Second, we will examine time for completing surveys. We will judge this trial feasible if: 1) the acceptance rate among eligible patients is equal to or greater than 70%. We will judge completion rates at follow-up to be feasible for a larger scale trial if our completion rate is 75%. 2) If the survey length averages are > 35 minutes, we will deem this unacceptable and shorten the survey.
2 secondary outcomes
Acceptability of BRDA
Time frame: 3 years
Impact of breast reconstruction decisional aid on knowledge and attitudes
Time frame: 3 years
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 24 Jan 2017.
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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.
Sharon Manne, PhD principal investigator
Rutgers Cancer Institute of New Jersey
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast Reconstruction Decisional Aid (BRDA) in people with Breast Cancer, run by Rutgers, The State University of New Jersey at 9 sites in United States.
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 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 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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?
Feasibility of a decisional aid to assist women with making the decision to undergo breast reconstruction (time frame: 3 years). 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 24 Jan 2017.