Breast CarcinomaNCT04817709
Development of a Patient Decision Aid for Women Considering Breast Reconstruction
An observational study of Breast Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This study engages cancer survivors who have considered breast reconstruction after mastectomy in developing and pilot testing an up-to-date, understandable, meaningful patient decision aid video and workbook. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Educational Intervention, Media Intervention and Medical Chart Review
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2017to 20 May 2021
- Phase
- Observational
- 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
Study population: Patients who are considering breast reconstruction surgery after mastectomy
Who may be able to join
- Aims 1 and 2: Patients who are 6 months to 3 years post-mastectomy surgery
- Aim 3: Patients who are scheduled for their first breast reconstruction consultation with plastic surgery
- Able to speak, read, and write English
Who cannot join
- Women with cognitive or psychological impairment (e.g., depression, anxiety, severe mental illness; as documented in their medical record)
- Women for whom the video and workbook would not be appropriate due to clinical characteristics or contraindications (as determined by a provider)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Patient Decision Aid for Women Considering Breast Reconstruction: User-Centered Design and Field-Testing
This study engages cancer survivors who have considered breast reconstruction after mastectomy in developing and pilot testing an up-to-date, understandable, meaningful patient decision aid video and workbook. Once the video and workbook are pilot-tested, a field test with new patients will then compare whether it is more feasible and useful for women considering breast reconstruction after mastectomy to view a video and workbook before their appointment or an educational booklet during their appointment. The video explains the process and types of reconstruction, the timeline for how breast reconstruction is done, and how the cost of this surgery is covered. The workbook helps patients compare your options and prepare for the appointment. The educational booklet explains the same process, types, timeline and costs, and is designed to help the patient and their surgeon compare and discuss the options together during the appointment. By comparing these two methods, researchers may learn which of these is more effective in helping patients make a decision about breast reconstruction.
Read the detailed description
PRIMARY OBJECTIVES:
- To design a patient decision aid video about breast reconstruction. II. To pilot test its acceptability with women. III. To field test the feasibility of delivery pre-consultation and efficacy at preparing women for their discussion with their plastic surgeon.
OUTLINE:
FOCUS GROUP: Survivors who previously considered breast reconstruction participate in a 40 to 60-minute focus group to gather feedback on currently-available patient decision aids and educational materials. The research team uses their feedback to create an initial prototype of a patient decision aid video
PILOT TEST: Survivors who previously considered breast reconstruction review the initial prototype of the patient decision aid video, then complete a questionnaire providing their feedback about the video's strengths and areas that could be improved. The research team then incorporates their feedback into the video."
FIELD TEST: Patients are randomized to 1 of 2 arms.
ARM I: Before their appointment, patients spend up to 30 minutes viewing a video and workbook. They also spend 5 to 10 minutes completing a questionnaire before and after the video and workbook, and again after their appointment. After their appointment, the research assistant reviews their medical record to confirm what decisions the patient and doctor made about breast reconstruction.
ARM II: During their appointment, patients spend up to 30 minutes reviewing the standard educational booklet about breast reconstruction. They also spend 5 to 10 minutes completing a questionnaire before and after the booklet, and again after their appointment. After their appointment, the research assistant reviews their medical record to confirm what decisions the patient and doctor made about breast reconstruction.
- Conditions
- Breast Carcinoma
- Being tested
- Educational Intervention, Usual Care, Media Intervention, Medical Chart Review, Questionnaire Administration
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Review workbook
Usual CareOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive educational materials
Media InterventionOther
Watch video
Medical Chart ReviewOther
Also called Chart Review
Review of medical records
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Patients view a video and read a workbook over 30 minutes about breast reconstruction surgery before their appointment. Patients also complete a questionnaire over 5-10 minutes before and after the video and after talking with the plastic surgeon. Patients' medical records are reviewed once they have made a decision about the type of reconstruction (if any). Receives: Other: Educational Intervention; Other: Media Intervention; Other: Medical Chart Review; Other: Questionnaire Administration | |
| Arm 2 | Patents receive an educational booklet about breast reconstruction surgery during appointment. Patients also complete a questionnaire over 5-10 minutes before and after talking with the plastic surgeon. Patients' medical records are reviewed once they have made a decision about the type of reconstruction (if any). Receives: Other: Usual Care; Other: Medical Chart Review; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery Rate
The statistician will calculate how many women to whom the research assistant was able to deliver the video/workbook or educational materials (i.e., by sending them the URL link or scheduling time to show them the video/workbook or educational materials on an iPad at the clinic), out of the total n = 130 eligible women. The statistician will also calculate the rates of women who prefer to view the video and workbook at home or at the clinic; and of women who re-visit the video and workbook after the consultation.
Measured: Up to 3 months prior to plastic surgery consultation
Secondary outcomes (5)
Breast Reconstruction Knowledge Questionnaire
This questionnaire includes 10 true/false items assessing participants' knowledge of breast reconstruction. Items are scored such that 0% correct responses equals no knowledge and 100% correct responses equals perfect knowledge.
Measured: Up to 3 months prior to plastic surgery consultation
Preparation for Decision Making Scale
This questionnaire includes 11 multiple choice items assessing how well-prepared participants feel they are for making this shared medical decision with their doctors. Participants rate each item on 5-point Likert scale from 1 (Not at all) to 5 (a great deal). To calculate a total score, responses are summed and multiplied by 2 to yield the total score. Total scores range from 0 (Poorly prepared) to 100 (Excellently prepared). Alpha coefficients observed between 0.92 to 0.96. This scale discriminates between people who do/do not find the decision aid helpful (p < 0.0001). For this study, a threshold of 75 out of 100 will be considered acceptable.
Measured: Immediately after intervention
Decisional Conflict Scale
This scale includes 16 question-items assessing participants' level of decisional conflict, defined as anxiety that blocks taking action. Participants rate each item on a Likert Scale with 5 responses from 0 (Not at All) to 4 (Extremely). Scores are summed, divided by 16, and multiplied by 25 to yield a total score of 0 (Less conflicted) to 100 (Highly conflicted). Total scores above 37.5 out of 100 are associated with delaying decisions and uncertainty about implementing their preferred treatment option; scores below 25 out of 100 are associated with making decisions and successfully implementing their preferred treatment option.
Measured: Immediately before intervention, immediately after intervention, immediately after consultation
BREAST-Questionnaire (Q)
The BREAST-Q assesses women's self-reported ratings of their satisfaction with their breasts and associated quality of life in terms of psychosocial, sexual, and physical well-being. Participants rate 64 items from 1 (Very Dissatisfied) to 4 (Very Satisfied). Psychometric properties include a person separation index of 0.76 to 0.95, Cronbach's alphas of 0.81 to 0.96, and test-retest reproducibility of 0.73 to 0.96 Before surgery, after surgery
Measured: Up to 1 year prior to surgery, up to 1 year after surgery
Type of surgery completed
The study coordinator will abstract the type(s) of reconstructive surgery completed, including immediate versus delayed reconstruction, autologous versus implant-based reconstruction, nipple reconstruction, contralateral balancing surgery, oncoplastic tissue rearrangement, and/or no reconstruction. This questionnaire is not a validated scale and thus no scoring or psychometric properties are appropriate. Responses will be used to model potential covariate relationships with the primary and other secondary outcome measures.
Measured: Up to 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start20 Mar 2017
- Primary completion20 May 2021
- Study completion20 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Reece, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817709
- Sponsor's protocol ID
- PA17-0002
- Other IDs
- NCI-2020-07838, PA17-0002
- Status last verified
- May 2021
- First submitted
- 29 Oct 2020
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Patient Decision Aid for Women Considering Breast Reconstruction: User-Centered Design and Field-Testing
- ClinicalTrials.gov ID
- NCT04817709
- Acronym / sponsor ID
- PA17-0002
- Conditions
- Breast Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 26 Mar 2021 (actual)
- 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 study engages cancer survivors who have considered breast reconstruction after mastectomy in developing and pilot testing an up-to-date, understandable, meaningful patient decision aid video and workbook. Once the video and workbook are pilot-tested, a field test with new patients will then compare whether it is more feasible and useful for women considering breast reconstruction after mastectomy to view a video and workbook before their appointment or an educational booklet during their appointment. The video explains the process and types of reconstruction, the timeline for how breast reconstruction is done, and how the cost of this surgery is covered. The workbook helps patients compare your options and prepare for the appointment. The educational booklet explains the same process, types, timeline and costs, and is designed to help the patient and their surgeon compare and discuss the options together during the appointment. By comparing these two methods, researchers may learn which of these is more effective in helping patients make a decision about breast reconstruction.
Detailed description
PRIMARY OBJECTIVES:
- To design a patient decision aid video about breast reconstruction. II. To pilot test its acceptability with women. III. To field test the feasibility of delivery pre-consultation and efficacy at preparing women for their discussion with their plastic surgeon.
OUTLINE:
FOCUS GROUP: Survivors who previously considered breast reconstruction participate in a 40 to 60-minute focus group to gather feedback on currently-available patient decision aids and educational materials. The research team uses their feedback to create an initial prototype of a patient decision aid video
PILOT TEST: Survivors who previously considered breast reconstruction review the initial prototype of the patient decision aid video, then complete a questionnaire providing their feedback about the video's strengths and areas that could be improved. The research team then incorporates their feedback into the video."
FIELD TEST: Patients are randomized to 1 of 2 arms.
ARM I: Before their appointment, patients spend up to 30 minutes viewing a video and workbook. They also spend 5 to 10 minutes completing a questionnaire before and after the video and workbook, and again after their appointment. After their appointment, the research assistant reviews their medical record to confirm what decisions the patient and doctor made about breast reconstruction.
ARM II: During their appointment, patients spend up to 30 minutes reviewing the standard educational booklet about breast reconstruction. They also spend 5 to 10 minutes completing a questionnaire before and after the booklet, and again after their appointment. After their appointment, the research assistant reviews their medical record to confirm what decisions the patient and doctor made about breast reconstruction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Other: Educational Intervention, Other: Media Intervention, Other: Medical Chart Review, Other: Questionnaire AdministrationPatients view a video and read a workbook over 30 minutes about breast reconstruction surgery before their appointment. Patients also complete a questionnaire over 5-10 minutes before and after the video and after talking with the plastic surgeon. Patients' medical records are reviewed once they have made a decision about the type of reconstruction (if any). |
| Arm 2 | – | Other: Usual Care, Other: Medical Chart Review, Other: Questionnaire AdministrationPatents receive an educational booklet about breast reconstruction surgery during appointment. Patients also complete a questionnaire over 5-10 minutes before and after talking with the plastic surgeon. Patients' medical records are reviewed once they have made a decision about the type of reconstruction (if any). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are considering breast reconstruction surgery after mastectomy
Key inclusion criteria (3 listed)
- Aims 1 and 2: Patients who are 6 months to 3 years post-mastectomy surgery
- Aim 3: Patients who are scheduled for their first breast reconstruction consultation with plastic surgery
- Able to speak, read, and write English
Key exclusion criteria (2 listed)
- Women with cognitive or psychological impairment (e.g., depression, anxiety, severe mental illness; as documented in their medical record)
- Women for whom the video and workbook would not be appropriate due to clinical characteristics or contraindications (as determined by a provider)
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 |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReview workbook | Other | Arm 1 |
| Usual CareAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive educational materials | Other | Arm 2 |
| Media InterventionWatch video | Other | Arm 1 |
| Medical Chart ReviewAlso: Chart ReviewReview of medical records | Other | Arm 1, Arm 2 |
| Questionnaire AdministrationComplete questionnaires | Other | Arm 1, Arm 2 |
Primary outcome
Delivery Rate
Time frame: Up to 3 months prior to plastic surgery consultation
The statistician will calculate how many women to whom the research assistant was able to deliver the video/workbook or educational materials (i.e., by sending them the URL link or scheduling time to show them the video/workbook or educational materials on an iPad at the clinic), out of the total n = 130 eligible women. The statistician will also calculate the rates of women who prefer to view the video and workbook at home or at the clinic; and of women who re-visit the video and workbook after the consultation.
5 secondary outcomes
Breast Reconstruction Knowledge Questionnaire
Time frame: Up to 3 months prior to plastic surgery consultation
Preparation for Decision Making Scale
Time frame: Immediately after intervention
Decisional Conflict Scale
Time frame: Immediately before intervention, immediately after intervention, immediately after consultation
BREAST-Questionnaire (Q)
Time frame: Up to 1 year prior to surgery, up to 1 year after surgery
Type of surgery completed
Time frame: Up to 1 year after surgery
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 May 2021.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Gregory Reece principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma, run by M.D. Anderson Cancer Center at 1 site 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 3 inclusion and 2 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 May 2021. 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 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?
Delivery Rate (time frame: Up to 3 months prior to plastic surgery consultation). 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 May 2021.