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NCT01649856 · OUTCOME

Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores

A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma · Source last updated 2017-10-11

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

Measure
MEAN
Unit
units on a scale
Interval / dispersion
Standard Deviation
Time frame
At Cycle 7 (each cycle was 14 or 21 days)

What was measured

The CTSQ is a validated 16-item questionnaire that measures three domains related to satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.

Analysis population: ITT Population (CTSQ Subpopulation): All participants who completed the CTSQ at Cycles 3 and 7; number (n) = number of participants in the analysis for the specified domain.

Groups in this outcome

Rituximab SC

Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m\^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.

Rituximab IV

Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m\^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.

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

Analysis denominator · Participants

GroupSource count
Rituximab SC280
Rituximab IV141

Reported measurements

Expectations of Therapy (n=280,141)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab SC79.3517.422Not reportedNot reportedNot reported
Rituximab IV82.9416.536Not reportedNot reportedNot reported
Feelings about Side Effects (n=276,141)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab SC60.6921.594Not reportedNot reportedNot reported
Rituximab IV57.6223.339Not reportedNot reportedNot reported
Satisfaction with Therapy (n=278,141)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab SC85.9211.428Not reportedNot reportedNot reported
Rituximab IV83.6013.451Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.422
        value
        79.35
      2. group Id
        OG001
        spread
        16.536
        value
        82.94
    title
    Expectations of Therapy (n=280,141)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.594
        value
        60.69
      2. group Id
        OG001
        spread
        23.339
        value
        57.62
    title
    Feelings about Side Effects (n=276,141)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.428
        value
        85.92
      2. group Id
        OG001
        spread
        13.451
        value
        83.60
    title
    Satisfaction with Therapy (n=278,141)
denoms
  1. counts
    1. group Id
      OG000
      value
      280
    2. group Id
      OG001
      value
      141
    units
    Participants
description
The CTSQ is a validated 16-item questionnaire that measures three domains related to satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.
dispersion Type
Standard Deviation
groups
  1. description
    Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m\^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
    id
    OG000
    title
    Rituximab SC
  2. description
    Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m\^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
    id
    OG001
    title
    Rituximab IV
param Type
MEAN
population Description
ITT Population (CTSQ Subpopulation): All participants who completed the CTSQ at Cycles 3 and 7; number (n) = number of participants in the analysis for the specified domain.
reporting Status
POSTED
time Frame
At Cycle 7 (each cycle was 14 or 21 days)
title
Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores
type
SECONDARY
unit Of Measure
units on a scale

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Preserved source evidence · Not medical advice