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| Title | Functional Assessment of Cancer Therapy-General Version 4 (FACT-G V4) |
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| CDISC Reference | Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
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| QRS Short Name | |
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| QRS Permission Status | Approved |
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| Team | Pancreatic Cancer Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
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| Supplement Version | 1.0 |
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| Status | DRAFT |
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| Date | 2023-0207-1028 |
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| Notes | - This supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.
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Revision History
| Date | Version |
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| 2023-0207-1028 | 1.0 Draft |
© 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
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This document describes the CDISC implementation of the Functional Assessment of Cancer Therapy-General Version 4 (FACT-G V4)| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | QRSSUPP-670 |
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instrument.
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2 Copyright Status
David Cella, PhD. , owns the copyright for the FACT-G V4 instrument and has granted CDISC permission to include this supplement in the CDISC inventory of QRS data standards supplements. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument.
These materials discuss and/or include the FACIT Measurement System, which is owned exclusively by Dr. David Cella. No part of the FACIT Measurement System may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of Dr. David Cella and payment of any applicable fees. Copyright Dr. David Cella. All rights reserved. Copyright 1987, 1997 David Cella, Ph.DPhD.
The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values.
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| Info |
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We are unable to make the example consistently show blue in the Wiki. All examples are updated for each QRS instrument so we ask that you please review the example below. |
The following table
| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | QRSSUPP-667 |
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represents the items from the
FACT-G V4 instrument.
The subject was not evaluated on this instrument at visit 2. Since the visit was missed, the reason for not completing the visit was not collected, and no date is assumed for when the visit would have occurred.| Dataset wrap |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSREASND | QSLOBXFL | VISITNUM | QSDTC | QSEVLINT |
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| 1 | STUDYX | QS | 2324-P0001 | 1 | FAC00101 | FAC001-I Have a Lack of Energy | FACT-G V4 | PHYSICAL WELL-BEING | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 2 | STUDYX | QS | 2324-P0001 | 2 | FAC00102 | FAC001-I Have Nausea | FACT-G V4 | PHYSICAL WELL-BEING | Not at all | 0 | 0 |
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| Y | 1 | 2015-05-15 | -P7D | | 3 | STUDYX | QS | 2324-P0001 | 3 | FAC00103 | FAC001-Trouble Meeting Needs of Family | FACT-G V4 | PHYSICAL WELL-BEING | Somewhat | 2 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | | 4 | STUDYX | QS | 2324-P0001 | 4 | FAC00104 | FAC001-I Have Pain | FACT-G V4 | PHYSICAL WELL-BEING | A little bit | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | | 5 | STUDYX | QS | 2324-P0001 | 5 | FAC00105 | FAC001-Botheredby Treatment Side Effect | FACT-G V4 | PHYSICAL WELL-BEING | Not at all | 0 | 0 |
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| Y | 1 | 2015-05-15 | -P7D | | 6 | STUDYX | QS | 2324-P0001 | 6 | FAC00106 | FAC001-I Feel Ill | FACT-G V4 | PHYSICAL WELL-BEING | A little bit | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | | 7 | STUDYX | QS | 2324-P0001 | 7 | FAC00107 | FAC001-I Am Forced to Spend Time in Bed | FACT-G V4 | PHYSICAL WELL-BEING | A little bit | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | | 8 | STUDYX | QS | 2324-P0001 | 8 | FAC00108 | FAC001-I Feel Close to My Friends | FACT-G V4 | SOCIAL/FAMILY WELL-BEING | Quite a bit | 3 | 3 |
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| Y | 1 | 2015-05-15 | -P7D | | 9 | STUDYX | QS | 2324-P0001 | 9 | FAC00109 | FAC001-Get Emotional Support From Family | FACT-G V4 | SOCIAL/FAMILY WELL-BEING | Quite a bit | 3 | 3 |
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| Y | 1 | 2015-05-15 | -P7D | | 10 | STUDYX | QS | 2324-P0001 | 10 | FAC00110 | FAC001-I Get Support From Friends | FACT-G V4 | SOCIAL/FAMILY WELL-BEING | Somewhat | 2 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | | 11 | STUDYX | QS | 2324-P0001 | 11 | FAC00111 | FAC001-My Family Has Accepted My Illness | FACT-G V4 | SOCIAL/FAMILY WELL-BEING | Quite a bit | 3 | 3 |
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| Y | 1 | 2015-05-15 | -P7D | | 12 | STUDYX | QS | 2324-P0001 | 12 | FAC00112 | FAC001-Satisfied Communication Illness | FACT-G V4 | SOCIAL/FAMILY WELL-BEING | Very much | 4 | 4 |
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| Y | 1 | 2015-05-15 | -P7D | | 13 | STUDYX | QS | 2324-P0001 | 13 | FAC00113 | FAC001-I Feel close to My Partner | FACT-G V4 | SOCIAL/FAMILY WELL-BEING | Very much | 4 | 4 |
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| Y | 1 | 2015-05-15 | -P7D | | 14 | STUDYX | QS | 2324-P0001 | 14 | FAC00114 | FAC001-I Am Satisfied With My Sex Life | FACT-G V4 | SOCIAL/FAMILY WELL-BEING |
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| NOT DONE | PREFER NOT TO ANSWER | Y| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | QRSSUPP-694 |
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| 1 | 2015-05-15 | -P7D | | 15 | STUDYX | QS | 2324-P0001 | 15 | FAC00115 | FAC001-I Feel Sad | FACT-G V4 | EMOTIONAL WELL-BEING | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 16 | STUDYX | QS | 2324-P0001 | 16 | FAC00116 | FAC001-Satisfied With How I Am Coping | FACT-G V4 | EMOTIONAL WELL-BEING | Quite a bit | 3 | 3 |
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| Y | 1 | 2015-05-15 | -P7D | | 17 | STUDYX | QS | 2324-P0001 | 17 | FAC00117 | FAC001-Losing Hope Against Illness | FACT-G V4 | EMOTIONAL WELL-BEING | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 18 | STUDYX | QS | 2324-P0001 | 18 | FAC00118 | FAC001-I Feel Nervous | FACT-G V4 | EMOTIONAL WELL-BEING | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 19 | STUDYX | QS | 2324-P0001 | 19 | FAC00119 | FAC001-I Worry About Dying | FACT-G V4 | EMOTIONAL WELL-BEING | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 20 | STUDYX | QS | 2324-P0001 | 20 | FAC00120 | FAC001-Worry My Condition Will Get Worse | FACT-G V4 | EMOTIONAL WELL-BEING | Somewhat | 2 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | | 21 | STUDYX | QS | 2324-P0001 | 21 | FAC00121 | FAC001-I Am Able to Work | FACT-G V4 | FUNCTIONAL WELL-BEING | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 22 | STUDYX | QS | 2324-P0001 | 22 | FAC00122 | FAC001-My Work Is Fulfilling | FACT-G V4 | FUNCTIONAL WELL-BEING | Quite a bit | 3 | 3 |
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| Y | 1 | 2015-05-15 | -P7D | | 23 | STUDYX | QS | 2324-P0001 | 23 | FAC00123 | FAC001-I Am Able to Enjoy Life | FACT-G V4 | FUNCTIONAL WELL-BEING | Quite a bit | 3 | 3 |
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| Y | 1 | 2015-05-15 | -P7D | | 24 | STUDYX | QS | 2324-P0001 | 24 | FAC00124 | FAC001-I Have Accepted My Illness | FACT-G V4 | FUNCTIONAL WELL-BEING | Somewhat | 2 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | | 25 | STUDYX | QS | 2324-P0001 | 25 | FAC00125 | FAC001-I Am Sleeping Well | FACT-G V4 | FUNCTIONAL WELL-BEING | Somewhat | 2 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | | 26 | STUDYX | QS | 2324-P0001 | 26 | FAC00126 | FAC001-Enjoy Things I Usually Do for Fun | FACT-G V4 | FUNCTIONAL WELL-BEING | Somewhat | 2 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | | 27 | STUDYX | QS | 2324-P0001 | 27 | FAC00127 | FAC001-Content With Quality of My Life | FACT-G V4 | FUNCTIONAL WELL-BEING | Quite a bit | 3 | 3 |
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| Y | 1 | 2015-05-15 | -P7D | | 28 | STUDYX | QS | 2324-P0001 | 28 | FAC00128 | FAC001-Physical Subscale Score | FACT-G V4 |
| 22 | 22 | 22 |
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| Y | 1 | 2015-05-15 | -P7D | | 29 | STUDYX | QS | 2324-P0001 | 29 | FAC00129 | FAC001-Social/Family Subscale Score | FACT-G V4 |
| 22 | 22 | 22 |
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| Y | 1 | 2015-05-15 | -P7D | | 30 | STUDYX | QS | 2324-P0001 | 30 | FAC00130 | FAC001-Emotional Subscale Score | FACT-G V4 |
| 17 | 17 | 17 |
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| Y | 1 | 2015-05-15 | -P7D | | 31 | STUDYX | QS | 2324-P0001 | 31 | FAC00131 | FAC001-Functional Subscale Score | FACT-G V4 |
| 16 | 16 | 16 |
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| Y | 1 | 2015-05-15 | -P7D | | 32 | STUDYX | QS | 2324-P0001 | 32 | FAC00132 | FAC001-Total Score | FACT-G V4 |
| 77 | 77 | 77 |
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| Y | 1 | 2015-05-15 | -P7D | | 33 | STUDYX | QS | 2324-P0001 | 33 | FAC00101 | FAC001-I Have a Lack of Energy | FACT-G V4 | PHYSICAL WELL-BEING |
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| NOT DONE |
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| 2 |
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| | 34 | STUDYX | QS | 2324-P0001 | 34 | FAC00102 | FAC001-I Have Nausea | FACT-G V4 | PHYSICAL WELL-BEING |
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| NOT DONE |
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| 2 |
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| | 35 | STUDYX | QS | 2324-P0001 | 35 | FAC00103 | FAC001-Trouble Meeting Needs of Family | FACT-G V4 | PHYSICAL WELL-BEING |
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| NOT DONE |
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| 2 |
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| | 36 | STUDYX | QS | 2324-P0001 | 36 | FAC00104 | FAC001-I Have Pain | FACT-G V4 | PHYSICAL WELL-BEING |
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| NOT DONE |
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| 2 |
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| | 37 | STUDYX | QS | 2324-P0001 | 37 | FAC00105 | FAC001-Botheredby Treatment Side Effect | FACT-G V4 | PHYSICAL WELL-BEING |
|
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| NOT DONE |
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| 2 |
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| | 38 | STUDYX | QS | 2324-P0001 | 38 | FAC00106 | FAC001-I Feel Ill | FACT-G V4 | PHYSICAL WELL-BEING |
|
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| NOT DONE |
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| 2 |
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| | 39 | STUDYX | QS | 2324-P0001 | 39 | FAC00107 | FAC001-I Am Forced to Spend Time in Bed | FACT-G V4 | PHYSICAL WELL-BEING |
|
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| NOT DONE |
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| 2 |
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| | 40 | STUDYX | QS | 2324-P0001 | 40 | FAC00108 | FAC001-I Feel Close to My Friends | FACT-G V4 | SOCIAL/FAMILY WELL-BEING |
|
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| NOT DONE |
|
| 2 |
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| | 41 | STUDYX | QS | 2324-P0001 | 41 | FAC00109 | FAC001-Get Emotional Support From Family | FACT-G V4 | SOCIAL/FAMILY WELL-BEING |
|
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| NOT DONE |
|
| 2 |
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| | 42 | STUDYX | QS | 2324-P0001 | 42 | FAC00110 | FAC001-I Get Support From Friends | FACT-G V4 | SOCIAL/FAMILY WELL-BEING |
|
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| NOT DONE |
|
| 2 |
|
| | 43 | STUDYX | QS | 2324-P0001 | 43 | FAC00111 | FAC001-My Family Has Accepted My Illness | FACT-G V4 | SOCIAL/FAMILY WELL-BEING |
|
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| NOT DONE |
|
| 2 |
|
| | 44 | STUDYX | QS | 2324-P0001 | 44 | FAC00112 | FAC001-Satisfied Communication Illness | FACT-G V4 | SOCIAL/FAMILY WELL-BEING |
|
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| NOT DONE |
|
| 2 |
|
| | 45 | STUDYX | QS | 2324-P0001 | 45 | FAC00113 | FAC001-I Feel close to My Partner | FACT-G V4 | SOCIAL/FAMILY WELL-BEING |
|
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| NOT DONE |
|
| 2 |
|
| | 46 | STUDYX | QS | 2324-P0001 | 46 | FAC00114 | FAC001-I Am Satisfied With My Sex Life | FACT-G V4 | SOCIAL/FAMILY WELL-BEING |
|
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| NOT DONE |
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| 2 |
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| | 47 | STUDYX | QS | 2324-P0001 | 47 | FAC00115 | FAC001-I Feel Sad | FACT-G V4 | EMOTIONAL WELL-BEING |
|
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| NOT DONE |
|
| 2 |
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| | 48 | STUDYX | QS | 2324-P0001 | 48 | FAC00116 | FAC001-Satisfied With How I Am Coping | FACT-G V4 | EMOTIONAL WELL-BEING |
|
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| NOT DONE |
|
| 2 |
|
| | 49 | STUDYX | QS | 2324-P0001 | 49 | FAC00117 | FAC001-Losing Hope Against Illness | FACT-G V4 | EMOTIONAL WELL-BEING |
|
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| NOT DONE |
|
| 2 |
|
| | 50 | STUDYX | QS | 2324-P0001 | 50 | FAC00118 | FAC001-I Feel Nervous | FACT-G V4 | EMOTIONAL WELL-BEING |
|
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| NOT DONE |
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| 2 |
|
| | 51 | STUDYX | QS | 2324-P0001 | 51 | FAC00119 | FAC001-I Worry About Dying | FACT-G V4 | EMOTIONAL WELL-BEING |
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| NOT DONE |
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| 2 |
|
| | 52 | STUDYX | QS | 2324-P0001 | 52 | FAC00120 | FAC001-Worry My Condition Will Get Worse | FACT-G V4 | EMOTIONAL WELL-BEING |
|
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| NOT DONE |
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| 2 |
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| | 53 | STUDYX | QS | 2324-P0001 | 53 | FAC00121 | FAC001-I Am Able to Work | FACT-G V4 | FUNCTIONAL WELL-BEING |
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| NOT DONE |
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| 2 |
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| | 54 | STUDYX | QS | 2324-P0001 | 54 | FAC00122 | FAC001-My Work Is Fulfilling | FACT-G V4 | FUNCTIONAL WELL-BEING |
|
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| NOT DONE |
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| 2 |
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| | 55 | STUDYX | QS | 2324-P0001 | 55 | FAC00123 | FAC001-I Am Able to Enjoy Life | FACT-G V4 | FUNCTIONAL WELL-BEING |
|
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| NOT DONE |
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| 2 |
|
| | 56 | STUDYX | QS | 2324-P0001 | 56 | FAC00124 | FAC001-I Have Accepted My Illness | FACT-G V4 | FUNCTIONAL WELL-BEING |
|
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| NOT DONE |
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| 2 |
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| | 57 | STUDYX | QS | 2324-P0001 | 57 | FAC00125 | FAC001-I Am Sleeping Well | FACT-G V4 | FUNCTIONAL WELL-BEING |
|
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| NOT DONE |
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| 2 |
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| | 58 | STUDYX | QS | 2324-P0001 | 58 | FAC00126 | FAC001-Enjoy Things I Usually Do for Fun | FACT-G V4 | FUNCTIONAL WELL-BEING |
|
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| NOT DONE |
|
| 2 |
|
| | 59 | STUDYX | QS | 2324-P0001 | 59 | FAC00127 | FAC001-Content With Quality of My Life | FACT-G V4 | FUNCTIONAL WELL-BEING |
|
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| NOT DONE |
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| 2 |
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| | 60 | STUDYX | QS | 2324-P0001 | 60 | FAC00128 | Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | QRSSUPP-668 |
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| FAC001-Physical Subscale Score | FACT-G V4 |
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| NOT DONE |
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| 2 |
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| | 61 | STUDYX | QS | 2324-P0001 | 61 | FAC00129 | FAC001-Social/Family Subscale Score | FACT-G V4 |
|
|
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| NOT DONE |
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| 2 |
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| | 62 | STUDYX | QS | 2324-P0001 | 62 | FAC00130 | FAC001-Emotional Subscale Score | FACT-G V4 |
|
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| NOT DONE |
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| 2 |
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| | 63 | STUDYX | QS | 2324-P0001 | 63 | FAC00131 | FAC001-Functional Subscale Score | FACT-G V4 |
|
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| NOT DONE |
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| 2 |
|
| | 64 | STUDYX | QS | 2324-P0001 | 64 | FAC00132 | FAC001-Total Score | FACT-G V4 |
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| NOT DONE |
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| 2 |
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This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.
QSSCAT alignment with QSTESTCD
As stated in Section 3.1 assumptions, Assumptions, items on the FACT-G V4 are grouped into subcategories. The following table below includes the subcategory names along with the applicable item numbers for each category. The values of the subcategories are used to populate QSSCAT and are annotated on the CRF.
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