Frequently Asked Questions
Q: What is the difference between FACT and FACIT?
A: "FACIT" (Functional Assessment of Chronic Illness Therapy) was adopted as the formal name of the measurement system in 1997 to portray the expansion of the more familiar "FACT" (Functional Assessment of Cancer Therapy) series of questionnaires into other chronic illnesses and conditions. Thus, FACIT is a broader, more encompassing term that includes the FACT questionnaires under its umbrella.
Q: How do I obtain permission to use one or more of the FACIT scales? Is there a fee for use?
A: Permission for use of one or more of the FACIT scales in English can be obtained by completing a simple users agreement by registering your project. By registering your project, you are agreeing to the points outlined on the Questionnaires page as well as the Copyright page of this website. Currently, there is no cost for use of any English version of the questionnaires. Translations will be emailed to you once you've registered and indicated the language and questionnaire you'd like to use. There is a fee of $1,500 per Latin language and $2,000 per non-Latin language for use in pharmaceutical clinical trials. Please contact us at firstname.lastname@example.org for a quote.
Q. Do I need permission to duplicate the form for use in a research project or clinical setting?
A: Yes, because to do otherwise would violate copyright law. However, we encourage its use and routinely grant permission as part of the initial registration. Duplicate copies can be made from an electronic or paper copy as long as the copyright is respected.
Q: When do I have to complete the registration?
A: The registration form is our way of tracking all of the various uses of questionnaires and their translations, so is not limited to those using it formally in a clinical trial. It is also your way of getting permission to copy and use the instrument as well as access to the scoring and interpretation materials. We ask that anyone planning on using one or more FACIT questionnaires for any purpose (where information will be collected from a patient or participant population) complete a copy of this form. This information is often useful in guiding development of new measures, languages, user tools, and interpretation guidelines. At times, it also provides us with opportunities to contact users for collaboration in an area of mutual interest. The information gathered is kept confidential to the extent possible, although generic summaries (not identifying user name or title of project) are often generated and may be made available to the public.
Q: Is it OK to re-format the questionnaires?
A: In general we encourage collaborators not to change the structure or format of the FACIT questionnaires. However, some small changes are acceptable, particularly if the changes are related to transferring the measure onto a case report form, or adapting it for computer or web-based applications. Since the FACIT scales are copyrighted instruments, we ask that you obtain permission from FACIT.org for any formatting or content changes and that any changes to a FACIT measure be clearly documented in any written report or publication.
Q. Is it O.K. to change the time frame used in the FACIT questionnaires?
A: Most of our data are available uses a time frame of the past 7 days (one week). So, changing the time frame risks ones ability to comfortably compare results to most of our available data. However, we and others have studied this and found little difference between responses to the same question using one time frame versus another. Therefore, the questions themselves tend to retain their validity and value, but the ability to compare to most available data is potentially limited.
Q: What are the alphanumeric codes to the left of each item on the FACIT questionnaires? Can I remove them or change the numbering?
A: The alphanumeric codes are used to uniquely identify individual FACIT items. The advantage of using alphanumeric codes (as opposed to consecutive numbering) is that they allow one to more easily compare common items across questionnaires in the measurement system, and over time as the content and order of questions may change. Any given question will have the same code, regardless of the questionnaire on which it is located. In addition, the FACIT scoring algorithms reference items by their alphanumeric codes, so we encourage collaborators to use the same when naming item variables in their data set. For these reasons, we do not recommend removing or changing the coding system from the forms.
ADMINISTERING THE QUESTIONNAIRE:
Q: What information is available on different modes of questionnaire administration?
A: Although the FACIT scales were originally developed for patient self-administration, we have data to support the validity of interviewer administration (when done by a trained interviewer), either person-to-person or by telephone. We have additional data to support the appropriateness of computer-administered versions of the questionnaire, and we are currently exploring other novel approaches such as audio-visual computer-based testing, computer automated telephone management, and web-based applications of the FACIT scales. Across these modes of administration, while there are always small differences, we have found essential equivalence. For further information, please refer to the modes of administration link.
Q: At what time intervals should I administer a FACIT questionnaire?
A: The administration timing of a FACIT questionnaire or symptom index in a clinical trial is typically based on several trial-specific issues, such as population (early versus advanced disease), endpoints, treatment schedules, QOL monitoring capability, and patient burden. Assessment timing should be a well-thought out process, with the goal of capturing enough data to be able to evaluate responsiveness to interventions or long term effects, while minimizing risks for patient burden and missing data. Administration of a FACIT questionnaire in a health-practice setting will require assessment timing according to different needs such as for the purpose of symptom management. More information regarding considerations for assessment timing can be found under the assessment timing link. Consultation services can also be provided by members of the FACIT.org team.
Q: How do I deal with questions that do not seem applicable for a particular patient group or project?
A: Usually the best strategy is to administer the entire scale, but plan a priori to evaluate the data focusing on the target (appropriate) questions only and the entire (validated) scale. If pilot testing with the target population (not just investigator opinion) reveals a truly not applicable question, it can be deleted but one loses the ability to compare data to available reference data.
At times, individual patients may feel that a given item is not applicable to them. An example would be the FACT-G Physical Well-Being item "I am bothered by side effects of treatment" where patients may feel as though they should skip the item because they are not currently receiving any treatment. In this circumstance, they should be encouraged to select the best response according to their level of "bother". If they are not receiving any treatment then they are not likely bothered by any side effects, so "not at all" would make the most sense. Patients should be encouraged to select the best possible response whenever possible, to avoid problems with missing data.
SELECTING A MEASURE:
Q: Can I use multiple disease specific scales together with the FACT-G?
A: Yes. The only concern is length of assessment and its burden on the patient.
Q: Is it O.K. to use only certain questions or subscales of the FACIT?
A: In general, yes. Combining available and relevant subscales should be done thoughtfully. Please keep in mind that many disease-specific subscales were developed to add to the FACT-G what was relevant in a particular type of cancer. This may mean that selecting only a disease-specific subscale will result in missing some important things only captured by the FACT-G. Unless relevancy or patient burden is of significant consideration, we recommend that the entire measure be used, with select subscales or combinations of subscales identified and analyzed as the primary or secondary endpoint(s).
Q: What is a symptom index?
A: Symptom indices are currently available for select tumor sites (e.g., the FACT Breast Symptom Index; FBSI). They were derived from existing FACT disease-specific scales due to a growing need for brief symptom-based patient-reported outcome measures. The indices are comprised of symptoms considered by cancer experts to be priority symptoms for targeted tumor sites, and are comprised of a combination of general cancer and disease-specific concerns. Please refer to the selecting an endpoint link for further information.
Q: Are the FACIT questionnaires appropriate for use with people other than cancer patients?
A: Yes. The FACT-G (the general version), created specifically for cancer patients, has been validated in HIV disease, multiple sclerosis, and even the general population (with minor modifications). Other FACIT questionnaires have to varying degrees been tested in different groups, so it is best to ask on a scale-by-scale basis.
Q: Is the FACT appropriate for cancer patients after they have completed treatment?
A: Yes. The FACT has been tested in several long-term survivor samples and found to be valid. It has been administered to people in the general population with minor modifications to establish population norms for interpretation.
Q. How do I gain access to the scoring and interpretation materials on the website?
A: Simply complete the registration and a username and password will be automatically generated for you.
Q. Where can I find normative data for comparisons?
A: Normative data are currently available for the FACT-G in its scoring and interpretation materials. Normative data does not exist for many of the subscales.
Q. Is it possible to compare across versions of the questionnaire?
A: Yes, we have scoring recommendations to help compare across versions 3 and 4 of the FACIT questionnaires.
Q: Are there scales of the FACT system that tend not to change much over time?
A: Yes, depending on the context of the evaluation. For example, the Social Well-Being (SWB) subscale of the FACT-G (the General version) tends not to change much in a clinical trial of a drug therapy for a medical condition. We assess SWB because it is important to people whose feedback has helped build these questionnaires. However, an investigator may opt to avoid using a non-responsive subset of questions as a trial endpoint. This does not mean excluding the subscale from the questionnaire, but rather selecting a score (a subscale score or the Trial Outcome Index) as the outcome endpoint, as the total score should be evaluated and will depend on the inclusion of the SWB subscale.
Q: What is the "Trial Outcome Index (TOI)?"
A: The Trial Outcome Index can be computed for any FACIT disease-, treatment-, or condition-specific scale. It is the sum of the Physical Well-Being (PWB), Functional Well-Being (FWB), and "additional concerns" subscales. The TOI is an efficient summary index of physical/functional outcomes. It is a common endpoint used in clinical trials, because it is responsive to change in physical/functional outcomes, sometimes more than a total (overall) multidimensional aggregated score which includes social and emotional well-being. While social and emotional well-being are very important to quality of life, they are not as likely to change as quickly or dramatically over-time or in response to therapy.
Q: What is a clinically meaningful difference?
A: Although much work is being done in this area, there is a lack of consensus on how clinical significance should be quantified. The FACIT approach has been to combine both anchor-based and distribution-based methods to derive estimates for our instruments. Distribution-based definitions are based on statistical distributions, e.g., effect size measures (Cohen, 1988) and other measures using means and standard deviations obtained from research studies or reference populations. Anchor-based interpretations of clinical meaningfulness are defined as measures that compare, or anchor, health-related quality of life changes (or differences) to other clinical changes (or groups). The most commonly used anchor-based measure is the global assessment originally described by researchers at McMaster University (Jaeschke, Singer & Guyatt, 1989). Another anchor that we have used is the ECOG performance status rating.
Q. How can I get copies of a translated version of a FACIT questionnaire?
A: License for use of a translated questionnaire may require a fee. This decision is made on an individual project basis according to the nature of the trial, the questionnaires and translations to be used, the sponsor, and standing contractual arrangements. Please e-mail us at email@example.com with any questions.
Q: What does linguistic validation of a FACIT measure mean?
A: A Linguistic validation study focuses on the quality of the translation and whether it was understandable by and relevant to the target population. This differs from a full scale validation in that only preliminary psychometric analysis is done if sufficient data are available. We do not investigate test-retest reliability in this type of validation study nor do we look at change over time. The main purpose is to assess the appropriateness of the translation that was conducted, in terms of equivalence with the English as well as cultural appropriateness. In theory, if the translation process creates an equivalent version of the questionnaire, then the psychometric properties of the original questionnaire should also apply to the translation. Therefore, full scale validation studies are not typically done for translations, although we do check validity and comparability of translations retrospectively when data are available.
Q: I am looking for a translation of a FACIT subscale that does not appear to be available. What should I do?
A: It is best that you contact us directly for an update on the status of translations of a particular subscale. We do our best to keep the information on the website up to date, but in some cases new translations are initiated before the website has been updated. If we confirm that the translation you are interested in is not yet available or is not in progress, then you must obtain permission to conduct a translation. Any translations conducted without such permission will be considered unauthorized translations. It is essential that all translations follow the FACIT Translation Methodology and be coordinated and approved by FACIT.org before being used in research studies or included in publications. Please e-mail us at firstname.lastname@example.org for more information.
Q: What user materials are available for administration, scoring and interpretation of results?
A: We have developed a variety of information to assist in the administration and scoring of the FACIT questionnaires, and in the interpretation of results. Please contact us with any questions.