NCT00103285 · OUTCOME

Optimal Time Point for Advance Health Related Quality of Life Intervention

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia · Source last updated 2021-06-14

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: At 1 month after diagnosis and 3 months post-therapy.

What was measured

Percentage of patients with elevated Anxiety.

Analysis population: Parents of 159 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the BASC-2 Anxiety Scale at 1 month after diagnosis, and 3 months post-therapy. Of these, 159 patients had data at 1 month after diagnosis and 96 patients had data at 3 months post therapy.

Groups in this outcome

Induction Therapy

All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) \< 0.1% OR MRD \>= 0.1% and \< 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD \>= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study. cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT vincristine sulfate: Given IV

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

Analysis denominator · Participants

Group	Source count
Induction Therapy	159

Reported measurements

At 1 month after diagnosis

Analysis denominator · Participants

Group	Source count
Induction Therapy	159

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Induction Therapy	25.2	Not reported	18.5	31.9	Not reported

At 3 months post-therapy

Analysis denominator · Participants

Group	Source count
Induction Therapy	96

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Induction Therapy	24.0	Not reported	16.0	32.0	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
1.31
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
12.73
group Description
Parents of 159 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the BASC-2 Anxiety Scale at 1 month after diagnosis, and 3 months post-therapy. Of these 159 had data at 1 month after diagnosis and 96 at 3 months post therapy.
group Ids
OG000
non Inferiority Type
OTHER
param Type
Odds Ratio (OR)
param Value
4.1
statistical Method
Regression, Logistic

Complete source fields

analyses

ci Lower Limit
1.31
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
12.73
group Description
Parents of 159 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the BASC-2 Anxiety Scale at 1 month after diagnosis, and 3 months post-therapy. Of these 159 had data at 1 month after diagnosis and 96 at 3 months post therapy.
group Ids
OG000
non Inferiority Type
OTHER
param Type
Odds Ratio (OR)
param Value
4.1
statistical Method
Regression, Logistic

classes

categories
measurements
group Id
OG000
lower Limit
18.5
upper Limit
31.9
value
25.2
denoms
counts
group Id
OG000
value
159
units
Participants
title
At 1 month after diagnosis
categories
measurements
group Id
OG000
lower Limit
16.0
upper Limit
32.0
value
24.0
denoms
counts
group Id
OG000
value
96
units
Participants
title
At 3 months post-therapy

denoms

counts
group Id
OG000
value
159
units
Participants

description

Percentage of patients with elevated Anxiety.

dispersion Type

95% Confidence Interval

groups

description
All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) \< 0.1% OR MRD \>= 0.1% and \< 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD \>= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study. cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT vincristine sulfate: Given IV
id
OG000
title
Induction Therapy

param Type

NUMBER

population Description

Parents of 159 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the BASC-2 Anxiety Scale at 1 month after diagnosis, and 3 months post-therapy. Of these, 159 patients had data at 1 month after diagnosis and 96 patients had data at 3 months post therapy.

reporting Status

POSTED

time Frame

At 1 month after diagnosis and 3 months post-therapy.

title

Optimal Time Point for Advance Health Related Quality of Life Intervention

type

SECONDARY

unit Of Measure

Percentage of participants

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Preserved source evidence · Not medical advice