The IRMA Study is a multicenter observational cohort study of women undergoing immediate breast reconstruction following either prophylactic mastectomy or mastectomy due to breast cancer.
The aim of immediate breast reconstruction following mastectomy (IRMA) is to rebuild the shape and appearance of the removed breast. IRMA includes skin-sparing mastectomy (SSM) and nipple-areola sparing mastectomy (NSM). Based on data from the US Surveillance, Epidemiology and End Result Program (SEER), NSM rates have risen 202% since 2009. Despite the increasing popularity of immediate breast reconstruction, limited prospective studies have been done to identify risk factors for complications. Of particular importance is to assess the effects of combining the procedure with radiotherapy, and undergoing a one- versus two-step surgical procedure.
This study's primary objective is to track prospectively postoperative complications, tumor recurrence as well as quality of life and body image among patients undergoing IRMA (skin-sparing mastectomy or nipple-areola sparing mastectomy).
By actively monitoring these patients, we aim to identify an optimal strategy for IRMA that may lead to the development of clinical guidelines, which are currently lacking.
The development of this study is led by the Brustzentrum Thurgau. Financial support has been provided by the Krebsliga Thurgau and private sponsors.
As of January 2022, 13 participating sites have recruited 207 out of 360 envisioned patients. Accrual has reached 58%.
Every clinical trial has to be registered in a public register before starting patient recruitment. Please find here the link to the Irma Trial at ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT04390529
Please find below some Frequently asked Questions (FAQs) to the questionnaires used in the IRMA trial.
What are the BREAST-Q© questionnaires?
Researchers worldwide use the BREAST-Q© questionnaires, which are available in multiple languages, to identify patients' attitudes and perceptions and track any changes over time. There are several different modules available. For the IRMA Study, we are using the Reconstruction module (Version 1.0).
The questionnaires have 2 overarching themes or domains:
2) patient satisfaction
When should the questionnaire(s) be given to the patients?
This should be completed before the initial surgery. It will serve as a reference point from which we will measure changes up to five years after surgery. It can be given to a patient any time after signing the informed consent, but it must be completed before undergoing the initial surgery.
Postoperative questionnaire (CRF 008)
This questionnaire should be completed 7 times (within 3 months after initial surgery, 6 months postoperatively, and annually for 5 years after surgery). The allowable time frame for completing most postoperative questionnaires is ±30 days of the scheduled date, except for the first postoperative questionnaire (7-90 days postoperatively).
Although the allowable timeframe to complete the first postoperative BREAST-Q questionnaire is 7 to 90 days after surgery (see protocol), we recommend giving the patients more rather than less time after the initial hospitalization. Moreover, the questionnaire's instructions refer to the respondent’s feelings over the “last 14 days”.
What if a patient does not complete a questionnaire?
There are several reasons why a patient may not complete a questionnaire. In the SecuTrial database, “not completed” can be selected, and then several common reasons are listed. If none of these reasons match the circumstances, please select “Other”, which will trigger a free text box entitled “Specify” where a brief explanation can typed.
Can a “missed” questionnaire be mailed to a patient?
Yes. If a questionnaire was mistakenly not given to the patient at her visit, a blank copy with her IRMA study unique identification number and a self-addressed envelope (preferably with pre-paid postage) could be sent in the mail to the patient. Please include a note indicating the date by which the questionnaire should be completed and returned.
What if the patient does not complete every item on a questionnaire?
Our study includes women undergoing a broad spectrum of treatment courses, ranging from those having the procedure for prophylactic reasons to breast cancer patients having two operations combined with other cancer treatment types. Therefore, not all sections of the questionnaires apply to every patient (i.e., not applicable).
A respondent should answer the questions relevant to her. In other words, if a question is asking about a procedure she did not have (e.g., a question about an implant but the patient had autologous tissue reconstruction), she should leave the question(s) blank. Otherwise, the patients should answer all questions.
What if there are missing answers, double entries (>1 answer marked), or the space between two responses was selected? How should this be handled in the database (SecuTrial)?
Unfortunately, there are standard SecuTrial response options when a value (answer) has not been given by the respondent. The ‘circle with a check mark inside’ to the right of the question (left of the responses) can be changed to indicate a ‘missing value’ but a reason must be provided.
When the circle is selected, the following other options appear:
- Value not collected Please select when the reason for missing value is unknown
- Value not collected due to rule Automatically generated by SecuTrial and can not be selected
- Other reason for missing value Please select when the response is unclear (e.g., double-entry) and then add a brief explanation in the free text box that appears directly below this option
When should we use the “comment” option on the far right-hand side of the screen?
Like many other databases, there is a possibility to provide additional details about special circumstances with data collection and entry. This is possible in our database by selecting “comment” on the right side of the screen. We do not want to discourage using this option; however, we hope that comments are entered sparingly and primarily to help clarify problems.
If a patient is in both the IRMA Study and the PREPEC Study, can only one questionnaire be completed instead of two?
No. Unfortunately, patients in both studies need to complete very similar questionnaires (yet different versions) on several occasions (preop, 6, 12, 24 months postoperatively – in addition to the first postop within 90 days). The IRMA Study began before Version 2.0 was released; therefore, we use Version 1.0. When you are enrolling patients who could be in both studies, please inform them that it will be slightly more effort to complete two questionnaires. We regret any inconvenience.
What if another hospitalization occurs during a reporting period, but the reoperation form (CRF 006) has already been completed?
If you have already completed a reoperation form (CRF 006) for the corresponding follow-up period and want to record additional hospitalizations, please select “Next visit” at the upper right-hand corner of the Visit plan. Please select from the drop-down menu the option “Add. Hospitalization 1”.