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NCT02767388 · OUTCOME

Change From Baseline Capture Task Performance at 1- and 3- Months

Electrophysiological Biomarkers of Chemotherapy-related Cognitive Impairment and Recovery · Source last updated 2023-09-29

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

Measure
MEAN
Unit
change in proportional response time
Interval / dispersion
Standard Deviation
Time frame
Collected at Study Induction, 1 month after Study Induction, 3 months after Study Induction

What was measured

Response time - measured as the time required to respond to a target hidden among distractor items - is the primary outcome measure of the capture task. Proportional response time was calculated by subtracting mean response time in the neutral condition from response time in the capture condition, and dividing that number by the standard deviation of response time across conditions. Changes in proportional response time across study visits is reported. Positive values correspond to an increase in response time and negative values correspond to a decrease in response time.

Analysis population: The number analyzed differed between rows due to participant dropout from Month-1 to Month-3. Differences in number analyzed and numbers in the Participant Flow module were due to patient dropout and either: (1) a minority of patients requesting not to complete testing; or (2) difficulties with electrophysiology or stimulus presentation equipment.

Groups in this outcome

HM - Chemotherapy

Study patients diagnosed with HM that are scheduled to receive chemotherapy treatment.

HM - No Chemotherapy

Study patients diagnosed with HM that are scheduled to receive non-chemotherapy treatment options.

Healthy Controls

Study participants that are demographically matched to HM study patients and meet all inclusion criteria

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

Analysis denominator · Participants

GroupSource count
HM - Chemotherapy8
HM - No Chemotherapy11
Healthy Controls12

Reported measurements

Change at 1-Month

Analysis denominator · Participants

GroupSource count
HM - Chemotherapy8
HM - No Chemotherapy11
Healthy Controls12
Values in change in proportional response time · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
HM - Chemotherapy.103.223Not reportedNot reportedNot reported
HM - No Chemotherapy-.039.190Not reportedNot reportedNot reported
Healthy Controls.066.201Not reportedNot reportedNot reported
Change at 3-Month

Analysis denominator · Participants

GroupSource count
HM - Chemotherapy8
HM - No Chemotherapy10
Healthy Controls11
Values in change in proportional response time · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
HM - Chemotherapy.067.113Not reportedNot reportedNot reported
HM - No Chemotherapy-.002.191Not reportedNot reportedNot reported
Healthy Controls-.084.165Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        .223
        value
        .103
      2. group Id
        OG001
        spread
        .190
        value
        -.039
      3. group Id
        OG002
        spread
        .201
        value
        .066
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        12
      units
      Participants
    title
    Change at 1-Month
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        .113
        value
        .067
      2. group Id
        OG001
        spread
        .191
        value
        -.002
      3. group Id
        OG002
        spread
        .165
        value
        -.084
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        11
      units
      Participants
    title
    Change at 3-Month
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      11
    3. group Id
      OG002
      value
      12
    units
    Participants
description
Response time - measured as the time required to respond to a target hidden among distractor items - is the primary outcome measure of the capture task. Proportional response time was calculated by subtracting mean response time in the neutral condition from response time in the capture condition, and dividing that number by the standard deviation of response time across conditions. Changes in proportional response time across study visits is reported. Positive values correspond to an increase in response time and negative values correspond to a decrease in response time.
dispersion Type
Standard Deviation
groups
  1. description
    Study patients diagnosed with HM that are scheduled to receive chemotherapy treatment.
    id
    OG000
    title
    HM - Chemotherapy
  2. description
    Study patients diagnosed with HM that are scheduled to receive non-chemotherapy treatment options.
    id
    OG001
    title
    HM - No Chemotherapy
  3. description
    Study participants that are demographically matched to HM study patients and meet all inclusion criteria
    id
    OG002
    title
    Healthy Controls
param Type
MEAN
population Description
The number analyzed differed between rows due to participant dropout from Month-1 to Month-3. Differences in number analyzed and numbers in the Participant Flow module were due to patient dropout and either: (1) a minority of patients requesting not to complete testing; or (2) difficulties with electrophysiology or stimulus presentation equipment.
reporting Status
POSTED
time Frame
Collected at Study Induction, 1 month after Study Induction, 3 months after Study Induction
title
Change From Baseline Capture Task Performance at 1- and 3- Months
type
PRIMARY
unit Of Measure
change in proportional response time

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Preserved source evidence · Not medical advice