Functional Assessment Of Cancer Therapy - General
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Functional Assessment of Cancer Therapy - General (FACT-G) is a patient-reported outcome measure used to assess health-related quality of life in patients undergoing
cancer Cancer is a group of diseases involving Cell growth#Disorders, abnormal cell growth with the potential to Invasion (cancer), invade or Metastasis, spread to other parts of the body. These contrast with benign tumors, which do not spread. Po ...
therapy. The FACT-G is the original questionnaire that led to the development of the larger Functional Assessment of Chronic Illness Therapy (FACIT) collection of quality of life instruments. The survey assesses the impacts of cancer therapy in four domains: physical, social/family, emotional, and functional. The FACT-G is also offered with additional questions measuring cancer-specific factors that may affect quality of life, leading to the creation of the Functional Assessment of Cancer Therapy -
Head and Neck This article describes the anatomy of the head and neck of the human body, including the brain, bones, muscles, blood vessels, nerves, glands, nose, mouth, teeth, tongue, and throat. Structure Bones The head rests on the top part of the vertebr ...
(FACT-H&N), the Functional Assessment of Cancer Therapy -
Lung The lungs are the primary Organ (biology), organs of the respiratory system in many animals, including humans. In mammals and most other tetrapods, two lungs are located near the Vertebral column, backbone on either side of the heart. Their ...
(FACT-L), and 18 others.


History and development

The Fact-G was developed by David Cella, now president and Chief Scientific Officer of FACIT.org and Chair of the Department of Medical Social Sciences at Northwestern University Feinberg School of Medicine. It was developed to assess the quality of life in cancer patients undergoing clinical trials for cancer therapy. Dr. Cella argues for the value of quality of life measures in general because "implicitly, the relief of a symptom is valued because of its associated benefit to patient function and well-being. Explicitly, it is essential to determine whether any supportive-care intervention is producing a benefit that outweighs its cost." Since development began in 1987, the initial 33-item Fact-G published in 1993 has undergone multiple revisions, with the latest version (Fact-G Version 4) "designed to enhance clarity and precision of measurement" through "formatting simplification, item-reduction, and rewording," resulting in the 27-item scale used today. In addition to revisions and refinement, the FACT-G has been translated into over 60 languages.


Structure and scoring

The FACT-G Version 4 has 27 questions, each of which is answered using a 5-point
Likert scale A Likert scale ( ,) is a psychometric scale named after its inventor, American social psychologist Rensis Likert, which is commonly used in research questionnaires. It is the most widely used approach to scaling responses in survey research, s ...
ranging from 0 (Not at all) to 4 (Very much). Questions are phrased so that higher numbers indicate a better health state, leading to some items being reverse-scored. Questions measure the respondents' health state over the last 7 days in four subscales: Physical Well-Being (PWB, 7 questions), Social/Family Well-Being (SWB, 7 questions), Emotional Well-Being (EWB, 6 questions), and Functional Well-being (FWB, 7 questions). Disease-specific versions of the FACT-G contain these four core subscales, with additional questions appended to address disease-specific factors. Scoring the FACT-G is performed through a simple sum of item scores. Each subscale is scored, and a total score for the FACT-G is obtained by adding each of the subscale scores. With a total possible score greater than 100, additional scoring methods have been used to simplify interpretation. Modifications of scoring include normalizing the total score on a scale of 0-100 through mathematical transformations, as well as the use of a Trial Outcome Index (TOI). The Trial Outcome Index is a simple sum of the Physical Well-Being and Functional Well-Being, and is intended as a summary index of functional status to be used as a clinical trials endpoint.


Current usage

The FACT-G is one of the most widely used patient-reported outcomes measures in cancer research along with the
European Organisation for Research and Treatment of Cancer The European Organisation for Research and Treatment of Cancer (EORTC) is a unique pan-European non-profit clinical cancer research organisation established in 1962 operating as an international association under Belgium law. It develops, conduc ...
Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), according to a 2011
systematic review A systematic review is a scholarly synthesis of the evidence on a clearly presented topic using critical methods to identify, define and assess research on the topic. A systematic review extracts and interprets data from published studies on ...
comparing the two instruments. The authors suggest that researchers interested in the financial impact and physical symptoms of cancer treatment use the EORTC QLQ-C30, while those interested in health-related quality of life or with limited sample sizes use the FACT-G. The review ultimately concludes that "Numerous studies have provided strong support for convergent and discriminant validity of both the QLQ-C30 and FACT-G" and provides an aid to "...clinical researchers in deciding which of the two questionnaires is the most appropriate for their purposes, driven by the outcomes that are of most interest." Professional organizations in the United States, United Kingdom, and Australia have embraced the FACT-G as a standard assessment of quality of life in cancer clinical trials. The
American Society of Clinical Oncology The American Society of Clinical Oncology (ASCO) is a professional organization representing physicians of all oncology sub-specialties who care for people with cancer. Founded in 1964 by Fred Ansfield, Harry Bisel, Herman Freckman, Arnoldus G ...
requested that the
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...
define the FACT-G as the gold standard assessment of health-related quality of life in a proposed amendment to the Food and Drug Administration's "Guidance for Industry on Clinical Trail Endpoints for the Approval of Cancer Drugs and Biologics" although, this amendment was not included in the May 2007 publication. The Patient-Reported Outcomes Measurement Group at the
University of Oxford The University of Oxford is a collegiate university, collegiate research university in Oxford, England. There is evidence of teaching as early as 1096, making it the oldest university in the English-speaking world and the List of oldest un ...
reported that the FACT-G is a promising patient-reported outcome measurement that is worth piloting in the
National Health Service The National Health Service (NHS) is the term for the publicly funded health care, publicly funded healthcare systems of the United Kingdom: the National Health Service (England), NHS Scotland, NHS Wales, and Health and Social Care (Northern ...
as a standard. Finally, The Cancer Institute NSW in Australia scored multiple quality of life instruments used in cancer care, and cited the FACT-G as "most appropriate in the cancer setting" when measuring health related quality of life in cancer patients.


Related scales

The creation of the FACT-G ultimately led to the development of the FACIT family of questionnaires for use in specific circumstances and additional diseases. There are over 20 cancer-specific scales such as the FACT-B for
breast cancer Breast cancer is a cancer that develops from breast tissue. Signs of breast cancer may include a Breast lump, lump in the breast, a change in breast shape, dimpling of the skin, Milk-rejection sign, milk rejection, fluid coming from the nipp ...
and FACT-C for
colorectal cancer Colorectal cancer (CRC), also known as bowel cancer, colon cancer, or rectal cancer, is the development of cancer from the Colon (anatomy), colon or rectum (parts of the large intestine). Signs and symptoms may include Lower gastrointestinal ...
and 27 symptom indexes which are short, 6 or 7 item subscales which focus only on symptoms. 12 treatment-specific measures focus on the quality of life impacts that patients receiving
enteral feeding A feeding tube is a medical device used to provide nutrition to people who cannot obtain nutrition by mouth, are unable to swallow safely, or need nutritional supplementation. The state of being fed by a feeding tube is called gavage, enteral fee ...
or with
neurotoxicity Neurotoxicity is a form of toxicity in which a biological, chemical, or physical agent produces an adverse effect on the structure or function of the central and/or peripheral nervous system. It occurs when exposure to a substance – specifical ...
experience. Finally, 13 non-cancer specific measures focus on topics beyond the impacts of disease and treatment, such as COST, which assesses financial impacts while the Facit-Sp measures spiritual well-being.


References

{{reflist Cancer treatments Clinical data management Clinical research Quality of life