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NCT02728804 · STUDY IN CONTEXT

S1417CD Financial Impact Assessment Tool in Patients With Metastatic Colorectal Cancer

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

The cumulative incidence estimates of participants experiencing both major financial hardship (MFH) and multiple financial hardships will be reported. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. A major financial hardship is defined as one or more of the following: debt accumulation of any amount, selling or refinancing home, \>= 20% income decline, borrowing money of any amount from family/friends.

The analysis population includes only the 302 participants that were evaluable for the primary endpoint - either completed 12-month evaluation or met primary endpoint.

→

secondary · POSTED

The cumulative incidence estimates of participants experiencing MFH within age groups. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. This is used to assess whether major financial hardship at one year differs by age (\< 65 vs. \>= 65). Age is taken at baseline.

There were a total of 302 participants analyzed which either completed the 12-month evaluation or met the primary endpoint.

→

secondary · POSTED

The cumulative incidence estimates of participants experiencing MFH within racial groups. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. This is used to assess whether major financial hardship at one year differs by race (white vs. non-white).

292 total participants were analyzed which had baseline race information available and either completed the 12-month evaluation or met the primary endpoint.

→

secondary · POSTED

The cumulative percentage of participants experiencing MFH within marital status groups. This is used to assess whether major financial hardship at one year differs by age (married vs. unmarried). Marital status is taken at baseline.

295 participants were analyzed who had baseline marital status information available and either completed the 12-month evaluation or met the primary endpoint.

→

secondary · POSTED

The cumulative incidence estimates of participants experiencing MFH within different employment status groups. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. This is used to assess whether major financial hardship at one year differs by pre-diagnosis employment status (any employment vs. unemployed). Employment status is taken at baseline.

295 participants were analyzed that had baseline employment status information available and either completed the 12-month evaluation or met the primary endpoint.

→

secondary · POSTED

The cumulative incidence estimates of participants experiencing MFH within income groups. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. This is used to assess whether major financial hardship at one year differs by household income (\<$50,000 vs. \>=$50,000 and \<$100,000 vs. \>=$100,000). Household income is taken at baseline.

294 total participants were analyzed which had baseline household income information available and either completed the 12-month evaluation or met the primary endpoint. The number of participants in the \<$50,000 arm and \>=$50,000 arm equal the total (294) participants analyzed. Similarly, the number of participants in the \<$100,000 arm and \>=$100,000 arm equal the total (294) participants analyzed.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

EORTC QLQ · Health-related Quality of Life (HRQOL) as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Version 3.0

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-eloxatin-e2dbb09f
nct id
NCT02728804
qol key
qol-0006
source section id
NCT02728804-om-0006
source outcome index
6
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Health-related Quality of Life (HRQOL) as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Version 3.0
measure definition
The relationship between major financial hardship and HRQOL will be assessed. Landmark analysis will be used to establish major financial hardship as a baseline predictor of HRQOL. In particular, patients will be categorized as having major financial hardship at their 3 month assessment (yes vs. no). Linear regression will then be used to assess whether the 3-month assessment of financial hardship predicts the 6-month HRQOL score. HRQOL at 3 months will be included as an adjustment covariate. The 6-month HRQOL score will be based on the EORTC QLQ-C30 questionnaire transformed into a linear sco
time frame
Up to 12 months
analysis role
secondary
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-eloxatin-e2dbb09f
nct id
NCT02728804
trial label
S1417CD Financial Impact Assessment Tool in Patients With Metastatic Colorectal Cancer
applicability
unclear
applicability note
Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
1
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT02728804
    outcome key
    om-0000
    source section id
    NCT02728804-om-0000
    source outcome index
    0
    endpoint
    Cumulative Incidence Rate of Treatment-related Major Financial Hardship
    endpoint definition
    The cumulative incidence estimates of participants experiencing both major financial hardship (MFH) and multiple financial hardships will be reported. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. A major financial hardship is defined as one or more of the following: debt accumulation of any amount, selling or refinancing home, \>= 20% income decline, borrowing money of any amount from family/friends.
    time origin
    Up to 12 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population includes only the 302 participants that were evaluable for the primary endpoint - either completed 12-month evaluation or met primary endpoint.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT02728804
    outcome key
    om-0001
    source section id
    NCT02728804-om-0001
    source outcome index
    1
    endpoint
    Association of Age and Cumulative Incidence Rate of Major Financial Hardship
    endpoint definition
    The cumulative incidence estimates of participants experiencing MFH within age groups. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. This is used to assess whether major financial hardship at one year differs by age (\< 65 vs. \>= 65). Age is taken at baseline.
    time origin
    Up to 12 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    There were a total of 302 participants analyzed which either completed the 12-month evaluation or met the primary endpoint.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT02728804
    outcome key
    om-0002
    source section id
    NCT02728804-om-0002
    source outcome index
    2
    endpoint
    Association of Race and Cumulative Incidence Rate of Major Financial Hardship
    endpoint definition
    The cumulative incidence estimates of participants experiencing MFH within racial groups. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. This is used to assess whether major financial hardship at one year differs by race (white vs. non-white).
    time origin
    Up to 12 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    292 total participants were analyzed which had baseline race information available and either completed the 12-month evaluation or met the primary endpoint.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT02728804
    outcome key
    om-0003
    source section id
    NCT02728804-om-0003
    source outcome index
    3
    endpoint
    Association of Marital Status and Cumulative Incidence Rate of Major Financial Hardship
    endpoint definition
    The cumulative percentage of participants experiencing MFH within marital status groups. This is used to assess whether major financial hardship at one year differs by age (married vs. unmarried). Marital status is taken at baseline.
    time origin
    Up to 12 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    295 participants were analyzed who had baseline marital status information available and either completed the 12-month evaluation or met the primary endpoint.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT02728804
    outcome key
    om-0004
    source section id
    NCT02728804-om-0004
    source outcome index
    4
    endpoint
    Association of Employment Status and Cumulative Incidence Rate of Major Financial Hardship
    endpoint definition
    The cumulative incidence estimates of participants experiencing MFH within different employment status groups. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. This is used to assess whether major financial hardship at one year differs by pre-diagnosis employment status (any employment vs. unemployed). Employment status is taken at baseline.
    time origin
    Up to 12 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    295 participants were analyzed that had baseline employment status information available and either completed the 12-month evaluation or met the primary endpoint.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT02728804
    outcome key
    om-0005
    source section id
    NCT02728804-om-0005
    source outcome index
    5
    endpoint
    Association of Income and Cumulative Incidence Rate of Major Financial Hardship
    endpoint definition
    The cumulative incidence estimates of participants experiencing MFH within income groups. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. This is used to assess whether major financial hardship at one year differs by household income (\<$50,000 vs. \>=$50,000 and \<$100,000 vs. \>=$100,000). Household income is taken at baseline.
    time origin
    Up to 12 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    294 total participants were analyzed which had baseline household income information available and either completed the 12-month evaluation or met the primary endpoint. The number of participants in the \<$50,000 arm and \>=$50,000 arm equal the total (294) participants analyzed. Similarly, the number of participants in the \<$100,000 arm and \>=$100,000 arm equal the total (294) participants analyzed.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT02728804
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Health Services Research (Questionnaire Administration)
    regimen
    Patients complete questionnaires (including the Baseline, Financial/Employment Impact, Insurance Impact, Quality of Life, and Treatment Perceptions questionnaires) over 30-60 minutes at baseline and at 3, 6, 9, and 12 months. Caregivers complete questionnaires over 30-60 minutes at baseline and at 6 and 12 months. Quality-of-Life Assessment: Complete questionnaire Questionnaire Administration: Complete questionnaires
    analyzed count
    302
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02728804-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT02728804
    outcome key
    om-0001
    arm key
    OG000
    arm label
    < 65 Years
    regimen
    This group is comprised of eligible and evaluable participants that are under 65 years of age.
    analyzed count
    192
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02728804-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT02728804
    outcome key
    om-0001
    arm key
    OG001
    arm label
    >=65 Years
    regimen
    This group is comprised of eligible and evaluable participants that are under 65 years of age.
    analyzed count
    110
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02728804-om-0001#groups/OG001
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT02728804
    outcome key
    om-0002
    arm key
    OG000
    arm label
    White
    regimen
    This group is comprised of eligible and evaluable participants that identify as White.
    analyzed count
    240
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02728804-om-0002#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT02728804
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Non-White
    regimen
    This group is comprised of eligible and evaluable participants that identify as a non-White race.
    analyzed count
    52
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02728804-om-0002#groups/OG001
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT02728804
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Not Married
    regimen
    This group is comprised of eligible and evaluable participants that are neither married nor partnered.
    analyzed count
    116
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02728804-om-0003#groups/OG000
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT02728804
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Married
    regimen
    This group is comprised of eligible and evaluable participants that are either married or partnered.
    analyzed count
    179
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02728804-om-0003#groups/OG001
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT02728804
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Unemployed
    regimen
    This group is comprised of eligible and evaluable participants that are unemployed.
    analyzed count
    101
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02728804-om-0004#groups/OG000
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT02728804
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Any Employment
    regimen
    This group is comprised of eligible and evaluable participants that are employed by any means. This includes full-time employment, part-time employment, self-employed, and on leave from full-time employment.
    analyzed count
    194
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02728804-om-0004#groups/OG001
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT02728804
    outcome key
    om-0005
    arm key
    OG000
    arm label
    <$50,000
    regimen
    This group is comprised of eligible and evaluable participants whose yearly income is less than $50,000.
    analyzed count
    168
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02728804-om-0005#groups/OG000
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT02728804
    outcome key
    om-0005
    arm key
    OG001
    arm label
    >=$50,000
    regimen
    This group is comprised of eligible and evaluable participants whose yearly income is at least $50,000.
    analyzed count
    126
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02728804-om-0005#groups/OG001
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT02728804
    outcome key
    om-0005
    arm key
    OG002
    arm label
    <$100,000
    regimen
    This group is comprised of eligible and evaluable participants whose yearly income is less than $100,000.
    analyzed count
    239
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02728804-om-0005#groups/OG002
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT02728804
    harm key
    EG000
    source section id
    NCT02728804-ae
    event group key
    EG000
    event group label
    Health Services Research (Questionnaire Administration)
    serious affected
    0
    serious at risk
    0
    other affected
    0
    other at risk
    0
    frequency threshold
    0
    collection period
    Duration of study participant - up to 12 months.
    event definition
    Serious adverse events and other (non-serious adverse events) were not assessed for the study. All-cause mortality was assessed for the 380 participants at the start of the study.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT02728804
    qol key
    qol-0006
    source section id
    NCT02728804-om-0006
    source outcome index
    6
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Health-related Quality of Life (HRQOL) as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Version 3.0
    measure definition
    The relationship between major financial hardship and HRQOL will be assessed. Landmark analysis will be used to establish major financial hardship as a baseline predictor of HRQOL. In particular, patients will be categorized as having major financial hardship at their 3 month assessment (yes vs. no). Linear regression will then be used to assess whether the 3-month assessment of financial hardship predicts the 6-month HRQOL score. HRQOL at 3 months will be included as an adjustment covariate. The 6-month HRQOL score will be based on the EORTC QLQ-C30 questionnaire transformed into a linear sco
    time frame
    Up to 12 months
    analysis role
    secondary
    reporting status
    NOT_POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice