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NCT02728804 · OUTCOME

Cumulative Incidence Rate of Treatment-related Major Financial Hardship

S1417CD Financial Impact Assessment Tool in Patients With Metastatic Colorectal Cancer · Source last updated 2023-01-26

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 12 months

What was measured

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.

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

Groups in this outcome

Health Services Research (Questionnaire Administration)

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Health Services Research (Questionnaire Administration)302

Reported measurements

Any MFH
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Health Services Research (Questionnaire Administration)71.3Not reported65.776.1Not reported
New Debt
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Health Services Research (Questionnaire Administration)57.6Not reported51.763.0Not reported
>=20% Income Decline
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Health Services Research (Questionnaire Administration)26.6Not reported21.332.0Not reported
Loans from Family and/or Friends
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Health Services Research (Questionnaire Administration)26.0Not reported21.530.7Not reported
Refinance of Home
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Health Services Research (Questionnaire Administration)3.4Not reported1.75.9Not reported
Sale of Home
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Health Services Research (Questionnaire Administration)2.6Not reported1.34.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        65.7
        upper Limit
        76.1
        value
        71.3
    title
    Any MFH
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        51.7
        upper Limit
        63.0
        value
        57.6
    title
    New Debt
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        21.3
        upper Limit
        32.0
        value
        26.6
    title
    >=20% Income Decline
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        21.5
        upper Limit
        30.7
        value
        26.0
    title
    Loans from Family and/or Friends
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.7
        upper Limit
        5.9
        value
        3.4
    title
    Refinance of Home
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.3
        upper Limit
        4.7
        value
        2.6
    title
    Sale of Home
denoms
  1. counts
    1. group Id
      OG000
      value
      302
    units
    Participants
description
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.
dispersion Type
95% Confidence Interval
groups
  1. description
    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
    id
    OG000
    title
    Health Services Research (Questionnaire Administration)
param Type
NUMBER
population Description
The analysis population includes only the 302 participants that were evaluable for the primary endpoint - either completed 12-month evaluation or met primary endpoint.
reporting Status
POSTED
time Frame
Up to 12 months
title
Cumulative Incidence Rate of Treatment-related Major Financial Hardship
type
PRIMARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice