• FAQ

    FAQ

    The most frequently asked questions

Frequently asked questions about clinical trials:

Below you will find an overview of the most frequently asked questions about Swiss-GO's clinical cancer research studies. We hope that you will find the right answer to your query directly. If not, please contact your doctor or email This email address is being protected from spambots. You need JavaScript enabled to view it..

 

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:
1) quality-of-life
2) patient satisfaction

When should the questionnaire(s) be given to the patients?

Preoperative questionnaire (CRF 007)
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).

Tip:
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.

FAQs IRMA Study Version2

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.

FAQs 2Study Version2

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”.

Address

Swiss GO Trial Group
Gynecological Oncology
Hospital for Women
University Hospital Basel
Spitalstrasse 21
CH-4031 Basel
Switzerland

Contact Info

Phone: +41 61 265 75 00
Fax:      +41 61 265 93 22

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