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Title

Functional Assessment of Cancer Therapy-General Version 4 (FACT-G V4)

CDISC ReferenceQuestionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

FACT-G V4

QRS Permission StatusApproved
TeamPancreatic Cancer Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Date2023-0207-1028
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

DateVersion
2023-0207-10281.0 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)

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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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  1. All items rated on a 5-point scale include a numeric rating (0-4) and a definition of what is represented by the rating (e.g., 0 = "Not at all", 4 = "Very much"). For the FACT-G V4, QSORRES is populated with the text description; the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.

    1. FAC00114 may be rated on a 5-point scale or the subject may prefer not to answer. When the checkbox is marked that the subject prefers not to rate answer the item, this is noted with QSSTAT = "NOT DONE" and QSREASND = "PREFER NOT TO ANSWER". QSORRES, QSSTRESC, and QSSTRESN are all missing.

  2. The time period of evaluation for the FACT-G V4 is populated in the QSEVLINT field in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the FACT-G V4 is the past 7 days (QSEVLINT = "-P7D").

  3. Items are divided into 4 subcategories

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    represented in QSSCAT: "PHYSICAL WELL-BEING", "SOCIAL/FAMILY WELL-BEING", "EMOTIONAL WELL-BEING", and "FUNCTIONAL WELL-BEING".

  4. Records are created in qs.xpt for every item on the instrument

    1. For items with no data, QSORRES, QSSTRESC, and QSSTRESN are all missing and QSSTAT = "NOT DONE".  If the reason is known then that reason is represented in QSREASND (e.g., QSREASND = "PREFER NOT TO ANSWER"). If the reason is unknown, then QSSTAT = "NOT DONE" and QSREASND is missing.

  5. The FACT-G V4 instrument includes subscale scores for each subcategory in addition to a total score per FACIT.org's scoring materials and are considered as captured data on the CRF and are not considered as derived in the example below. These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from FACIT.org.

    1. Subscores and total scores are represented in QSORRES.

    2. If scores are received or derived by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM whenever feasible.
  6. Terminology
    1. QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.

    2. A full list of value sets for the result field is provided in Section 4, SDTM Mapping Strategy.

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Info

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

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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
Nameqs
Dataset2
RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSSCATQSORRESQSSTRESCQSSTRESNQSSTATQSREASNDQSLOBXFLVISITNUMQSDTCQSEVLINT
1STUDYXQS2324-P00011FAC00101FAC001-I Have a Lack of EnergyFACT-G V4PHYSICAL WELL-BEINGA little bit11

Y12015-05-15-P7D
2STUDYXQS2324-P00012FAC00102FAC001-I Have NauseaFACT-G V4PHYSICAL WELL-BEINGNot at all00

Y12015-05-15-P7D
3STUDYXQS2324-P00013FAC00103FAC001-Trouble Meeting Needs of FamilyFACT-G V4PHYSICAL WELL-BEINGSomewhat22

Y12015-05-15-P7D
4STUDYXQS2324-P00014FAC00104FAC001-I Have PainFACT-G V4PHYSICAL WELL-BEINGA little bit11

Y12015-05-15-P7D
5STUDYXQS2324-P00015FAC00105FAC001-Botheredby Treatment Side EffectFACT-G V4PHYSICAL WELL-BEINGNot at all00

Y12015-05-15-P7D
6STUDYXQS2324-P00016FAC00106FAC001-I Feel IllFACT-G V4PHYSICAL WELL-BEINGA little bit11

Y12015-05-15-P7D
7STUDYXQS2324-P00017FAC00107FAC001-I Am Forced to Spend Time in BedFACT-G V4PHYSICAL WELL-BEINGA little bit11

Y12015-05-15-P7D
8STUDYXQS2324-P00018FAC00108FAC001-I Feel Close to My FriendsFACT-G V4SOCIAL/FAMILY WELL-BEINGQuite a bit33

Y12015-05-15-P7D
9STUDYXQS2324-P00019FAC00109FAC001-Get Emotional Support From FamilyFACT-G V4SOCIAL/FAMILY WELL-BEINGQuite a bit33

Y12015-05-15-P7D
10STUDYXQS2324-P000110FAC00110FAC001-I Get Support From FriendsFACT-G V4SOCIAL/FAMILY WELL-BEINGSomewhat22

Y12015-05-15-P7D
11STUDYXQS2324-P000111FAC00111FAC001-My Family Has Accepted My IllnessFACT-G V4SOCIAL/FAMILY WELL-BEINGQuite a bit33

Y12015-05-15-P7D
12STUDYXQS2324-P000112FAC00112FAC001-Satisfied Communication IllnessFACT-G V4SOCIAL/FAMILY WELL-BEINGVery much44

Y12015-05-15-P7D
13STUDYXQS2324-P000113FAC00113FAC001-I Feel close to My PartnerFACT-G V4SOCIAL/FAMILY WELL-BEINGVery much44

Y12015-05-15-P7D
14STUDYXQS2324-P000114FAC00114FAC001-I Am Satisfied With My Sex LifeFACT-G V4SOCIAL/FAMILY WELL-BEING


NOT DONEPREFER NOT TO ANSWERY
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12015-05-15-P7D
15STUDYXQS2324-P000115FAC00115FAC001-I Feel SadFACT-G V4EMOTIONAL WELL-BEINGA little bit11

Y12015-05-15-P7D
16STUDYXQS2324-P000116FAC00116FAC001-Satisfied With How I Am CopingFACT-G V4EMOTIONAL WELL-BEINGQuite a bit33

Y12015-05-15-P7D
17STUDYXQS2324-P000117FAC00117FAC001-Losing Hope Against IllnessFACT-G V4EMOTIONAL WELL-BEINGA little bit11

Y12015-05-15-P7D
18STUDYXQS2324-P000118FAC00118FAC001-I Feel NervousFACT-G V4EMOTIONAL WELL-BEINGA little bit11

Y12015-05-15-P7D
19STUDYXQS2324-P000119FAC00119FAC001-I Worry About DyingFACT-G V4EMOTIONAL WELL-BEINGA little bit11

Y12015-05-15-P7D
20STUDYXQS2324-P000120FAC00120FAC001-Worry My Condition Will Get WorseFACT-G V4EMOTIONAL WELL-BEINGSomewhat22

Y12015-05-15-P7D
21STUDYXQS2324-P000121FAC00121FAC001-I Am Able to WorkFACT-G V4FUNCTIONAL WELL-BEINGA little bit11

Y12015-05-15-P7D
22STUDYXQS2324-P000122FAC00122FAC001-My Work Is FulfillingFACT-G V4FUNCTIONAL WELL-BEINGQuite a bit33

Y12015-05-15-P7D
23STUDYXQS2324-P000123FAC00123FAC001-I Am Able to Enjoy LifeFACT-G V4FUNCTIONAL WELL-BEINGQuite a bit33

Y12015-05-15-P7D
24STUDYXQS2324-P000124FAC00124FAC001-I Have Accepted My IllnessFACT-G V4FUNCTIONAL WELL-BEINGSomewhat22

Y12015-05-15-P7D
25STUDYXQS2324-P000125FAC00125FAC001-I Am Sleeping WellFACT-G V4FUNCTIONAL WELL-BEINGSomewhat22

Y12015-05-15-P7D
26STUDYXQS2324-P000126FAC00126FAC001-Enjoy Things I Usually Do for FunFACT-G V4FUNCTIONAL WELL-BEINGSomewhat22

Y12015-05-15-P7D
27STUDYXQS2324-P000127FAC00127FAC001-Content With Quality of My LifeFACT-G V4FUNCTIONAL WELL-BEINGQuite a bit33

Y12015-05-15-P7D
28STUDYXQS2324-P000128FAC00128FAC001-Physical Subscale ScoreFACT-G V4
222222

Y12015-05-15-P7D
29STUDYXQS2324-P000129FAC00129FAC001-Social/Family Subscale ScoreFACT-G V4
222222

Y12015-05-15-P7D
30STUDYXQS2324-P000130FAC00130FAC001-Emotional Subscale ScoreFACT-G V4
171717

Y12015-05-15-P7D
31STUDYXQS2324-P000131FAC00131FAC001-Functional Subscale ScoreFACT-G V4
161616

Y12015-05-15-P7D
32STUDYXQS2324-P000132FAC00132FAC001-Total ScoreFACT-G V4
777777

Y12015-05-15-P7D
33STUDYXQS2324-P000133FAC00101FAC001-I Have a Lack of EnergyFACT-G V4PHYSICAL WELL-BEING


NOT DONE

2

34STUDYXQS2324-P000134FAC00102FAC001-I Have NauseaFACT-G V4PHYSICAL WELL-BEING


NOT DONE

2

35STUDYXQS2324-P000135FAC00103FAC001-Trouble Meeting Needs of FamilyFACT-G V4PHYSICAL WELL-BEING


NOT DONE

2

36STUDYXQS2324-P000136FAC00104FAC001-I Have PainFACT-G V4PHYSICAL WELL-BEING


NOT DONE

2

37STUDYXQS2324-P000137FAC00105FAC001-Botheredby Treatment Side EffectFACT-G V4PHYSICAL WELL-BEING


NOT DONE

2

38STUDYXQS2324-P000138FAC00106FAC001-I Feel IllFACT-G V4PHYSICAL WELL-BEING


NOT DONE

2

39STUDYXQS2324-P000139FAC00107FAC001-I Am Forced to Spend Time in BedFACT-G V4PHYSICAL WELL-BEING


NOT DONE

2

40STUDYXQS2324-P000140FAC00108FAC001-I Feel Close to My FriendsFACT-G V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

41STUDYXQS2324-P000141FAC00109FAC001-Get Emotional Support From FamilyFACT-G V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

42STUDYXQS2324-P000142FAC00110FAC001-I Get Support From FriendsFACT-G V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

43STUDYXQS2324-P000143FAC00111FAC001-My Family Has Accepted My IllnessFACT-G V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

44STUDYXQS2324-P000144FAC00112FAC001-Satisfied Communication IllnessFACT-G V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

45STUDYXQS2324-P000145FAC00113FAC001-I Feel close to My PartnerFACT-G V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

46STUDYXQS2324-P000146FAC00114FAC001-I Am Satisfied With My Sex LifeFACT-G V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

47STUDYXQS2324-P000147FAC00115FAC001-I Feel SadFACT-G V4EMOTIONAL WELL-BEING


NOT DONE

2

48STUDYXQS2324-P000148FAC00116FAC001-Satisfied With How I Am CopingFACT-G V4EMOTIONAL WELL-BEING


NOT DONE

2

49STUDYXQS2324-P000149FAC00117FAC001-Losing Hope Against IllnessFACT-G V4EMOTIONAL WELL-BEING


NOT DONE

2

50STUDYXQS2324-P000150FAC00118FAC001-I Feel NervousFACT-G V4EMOTIONAL WELL-BEING


NOT DONE

2

51STUDYXQS2324-P000151FAC00119FAC001-I Worry About DyingFACT-G V4EMOTIONAL WELL-BEING


NOT DONE

2

52STUDYXQS2324-P000152FAC00120FAC001-Worry My Condition Will Get WorseFACT-G V4EMOTIONAL WELL-BEING


NOT DONE

2

53STUDYXQS2324-P000153FAC00121FAC001-I Am Able to WorkFACT-G V4FUNCTIONAL WELL-BEING


NOT DONE

2

54STUDYXQS2324-P000154FAC00122FAC001-My Work Is FulfillingFACT-G V4FUNCTIONAL WELL-BEING


NOT DONE

2

55STUDYXQS2324-P000155FAC00123FAC001-I Am Able to Enjoy LifeFACT-G V4FUNCTIONAL WELL-BEING


NOT DONE

2

56STUDYXQS2324-P000156FAC00124FAC001-I Have Accepted My IllnessFACT-G V4FUNCTIONAL WELL-BEING


NOT DONE

2

57STUDYXQS2324-P000157FAC00125FAC001-I Am Sleeping WellFACT-G V4FUNCTIONAL WELL-BEING


NOT DONE

2

58STUDYXQS2324-P000158FAC00126FAC001-Enjoy Things I Usually Do for FunFACT-G V4FUNCTIONAL WELL-BEING


NOT DONE

2

59STUDYXQS2324-P000159FAC00127FAC001-Content With Quality of My LifeFACT-G V4FUNCTIONAL WELL-BEING


NOT DONE

2

60STUDYXQS2324-P000160

FAC00128

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FAC001-Physical Subscale ScoreFACT-G V4



NOT DONE

2

61STUDYXQS2324-P000161FAC00129FAC001-Social/Family Subscale ScoreFACT-G V4



NOT DONE

2

62STUDYXQS2324-P000162FAC00130FAC001-Emotional Subscale ScoreFACT-G V4



NOT DONE

2

63STUDYXQS2324-P000163FAC00131FAC001-Functional Subscale ScoreFACT-G V4



NOT DONE

2

64STUDYXQS2324-P000164FAC00132FAC001-Total ScoreFACT-G V4



NOT DONE

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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